A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis

• ClinicalTrials.gov Identifier: NCT03895372
• Recruitment Status: Completed
• First Posted: March 29, 2019
• Results First Posted: August 27, 2021
• Last Update Posted: August 27, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Psoriasis
• Interventions: Drug: PF-06826647 or Placebo; Drug: PF-06826647
• Enrollment: 179

Participant Flow

Recruitment Details

This study included 2 treatment periods (16-week investigational treatment period and 24-week extension treatment period) followed by a 4-week follow-up. A total of 179 participants were enrolled and 178 participants were treated in investigational treatment period and 153 participants completed this period and entered the extension treatment period. A total of 130 participants completed the extension treatment period.

Pre-assignment Details

This was a Phase 2b, randomized, double blind, placebo controlled, parallel group, and multicenter study in participants with moderate to severe plaque psoriasis.

Arm/Group Title	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Arm/Group Description	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.	This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Period Title: Investigational Treatment Period
Started	23	22	11	11	12	11	45	43
Completed	19	19	10	9	12	9	37	38
Not Completed	4	3	1	2	0	2	8	5
Reason Not Completed
Adverse Event	1	0	0	0	0	0	4	3
Lack of Efficacy	1	0	0	0	0	0	0	0
Lost to Follow-up	0	0	0	0	0	0	1	0
Other	0	0	0	0	0	1	0	2
Protocol Violation	0	0	0	1	0	0	0	0
Withdrawal by Subject	2	3	1	1	0	1	3	0
Period Title: Extension Treatment Period
Started	19	19	10	9	12	9	37	38
Completed	16	14	10	8	9	8	33	32
Not Completed	3	5	0	1	3	1	4	6
Reason Not Completed
Adverse Event	0	1	0	1	0	0	3	3
Other	1	3	0	0	1	0	0	2
Pregnancy	0	0	0	0	1	0	0	0
Withdrawal by Subject	2	1	0	0	1	1	1	1

Baseline Characteristics

Arm/Group Title		Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group	Total
Arm/Group Description		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.	This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.	Total of all reporting groups
Overall Number of Baseline Participants		23	22	11	11	12	11	45	43	178
Baseline Analysis Population Description		Demographic and baseline characteristics were summarized by randomized treatment group for all randomized and treated participants.
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	23 participants	22 participants	11 participants	11 participants	12 participants	11 participants	45 participants	43 participants	178 participants
18-44 Years		9 39.1%	11 50.0%	7 63.6%	3 27.3%	6 50.0%	6 54.5%	24 53.3%	20 46.5%	86 48.3%
45-64 Years		12 52.2%	9 40.9%	4 36.4%	6 54.5%	6 50.0%	4 36.4%	19 42.2%	20 46.5%	80 44.9%
>=65 Years		2 8.7%	2 9.1%	0 0.0%	2 18.2%	0 0.0%	1 9.1%	2 4.4%	3 7.0%	12 6.7%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	23 participants	22 participants	11 participants	11 participants	12 participants	11 participants	45 participants	43 participants	178 participants
	Female	7 30.4%	8 36.4%	2 18.2%	5 45.5%	3 25.0%	4 36.4%	19 42.2%	8 18.6%	56 31.5%
	Male	16 69.6%	14 63.6%	9 81.8%	6 54.5%	9 75.0%	7 63.6%	26 57.8%	35 81.4%	122 68.5%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	23 participants	22 participants	11 participants	11 participants	12 participants	11 participants	45 participants	43 participants	178 participants
	Hispanic or Latino	1 4.3%	1 4.5%	1 9.1%	0 0.0%	1 8.3%	0 0.0%	1 2.2%	4 9.3%	9 5.1%
	Not Hispanic or Latino	22 95.7%	21 95.5%	10 90.9%	11 100.0%	11 91.7%	11 100.0%	44 97.8%	39 90.7%	169 94.9%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	23 participants	22 participants	11 participants	11 participants	12 participants	11 participants	45 participants	43 participants	178 participants
White		20 87.0%	19 86.4%	10 90.9%	11 100.0%	10 83.3%	11 100.0%	37 82.2%	40 93.0%	158 88.8%
Black or African American		0 0.0%	1 4.5%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.2%	1 2.3%	3 1.7%
Asian		3 13.0%	2 9.1%	1 9.1%	0 0.0%	2 16.7%	0 0.0%	6 13.3%	2 4.7%	16 9.0%
Native Hawaiian or Other Pacific Islander		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.2%	0 0.0%	1 0.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period
Description	The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. The statistical analysis was for the data at Week 16.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).

Arm/Group Title	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed	42	22	21	45	41
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
Week 1	0; (0.00 to 6.41)	0; (0.00 to 12.60)	0; (0.00 to 12.33)	0; (0.00 to 5.97)	0; (0.00 to 6.57)
Week 2	0; (0.00 to 6.41)	0; (0.00 to 12.60)	0; (0.00 to 12.33)	2.2; (0.23 to 9.17)	0; (0.00 to 6.57)
Week 4	0; (0.00 to 6.41)	0; (0.00 to 12.60)	0; (0.00 to 12.33)	11.1; (5.50 to 21.80)	7.3; (2.72 to 17.32)
Week 6	0; (0.00 to 6.41)	4.5; (0.48 to 19.56)	4.8; (0.50 to 20.57)	20.0; (11.72 to 31.73)	26.8; (17.12 to 39.77)
Week 8	2.4; (0.25 to 9.85)	4.5; (0.48 to 19.56)	4.8; (0.50 to 20.57)	24.4; (15.47 to 35.88)	34.1; (23.04 to 46.94)
Week 12	2.4; (0.25 to 9.85)	13.6; (5.12 to 31.13)	9.5; (2.56 to 24.50)	37.8; (25.96 to 50.95)	48.8; (35.14 to 62.56)
Week 16	4.8; (1.27 to 13.53)	13.6; (5.12 to 31.13)	9.5; (2.56 to 24.50)	37.8; (25.96 to 50.95)	51.2; (37.44 to 64.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 50 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2621
	Comments	One-sided Hochberg p-value, significant level is 0.05.
	Method	Chan and Zhang method
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	8.87
	Confidence Interval	(2-Sided) 90%; -4.50 to 26.26
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 100 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2621
	Comments	One-sided Hochberg p-value, significant level is 0.05.
	Method	Chan and Zhang method
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	4.76
	Confidence Interval	(2-Sided) 90%; -7.07 to 21.48
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 200 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0004
	Comments	One-sided Hochberg p-value, significant level is 0.05.
	Method	Chan and Zhang method
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	33.02
	Confidence Interval	(2-Sided) 90%; 18.01 to 47.11
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 400 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	One-sided Hochberg p-value, significant level is 0.05.
	Method	Chan and Zhang method
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	46.46
	Confidence Interval	(2-Sided) 90%; 30.62 to 60.56
	Estimation Comments	[Not Specified]

2. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period
Description	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time.
Time Frame	From Week 16 to Week 40

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period.

Arm/Group Title	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Arm/Group Description:	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.	This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Overall Number of Participants Analyzed	19	18	10	9	12	9	37	38
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with AEs	11 57.9%	8 44.4%	7 70.0%	6 66.7%	7 58.3%	7 77.8%	24 64.9%	26 68.4%
Participants with SAEs	0 0.0%	1 5.6%	0 0.0%	0 0.0%	0 0.0%	1 11.1%	2 5.4%	0 0.0%
Participants with severe AEs	2 10.5%	0 0.0%	0 0.0%	0 0.0%	1 8.3%	2 22.2%	2 5.4%	3 7.9%
Participants discontinued from study due to AEs	0 0.0%	1 5.6%	0 0.0%	1 11.1%	1 8.3%	0 0.0%	3 8.1%	3 7.9%
Participants discontinued study drug due to AE and continue study	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 8.3%	0 0.0%	1 2.7%	0 0.0%
Participants with dose reduced or temporary discontinuation due to AEs	0 0.0%	0 0.0%	1 10.0%	0 0.0%	0 0.0%	1 11.1%	4 10.8%	1 2.6%

3. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period
Description	Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame	From Week 16 to Week 40

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who entered the extension treatment period.

Arm/Group Title	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Arm/Group Description:	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.	This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Overall Number of Participants Analyzed	19	18	10	9	12	9	37	38
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with AEs	4 21.1%	3 16.7%	2 20.0%	3 33.3%	0 0.0%	1 11.1%	10 27.0%	5 13.2%
Participants with SAEs	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 5.4%	0 0.0%
Participants with severe AEs	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.7%	1 2.6%
Participants discontinued from study due to AEs	0 0.0%	1 5.6%	0 0.0%	1 11.1%	0 0.0%	0 0.0%	2 5.4%	2 5.3%
Participants discontinued study drug due to AE and continue study	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Participants with dose reduced or temporary discontinuation due to AEs	0 0.0%	0 0.0%	1 10.0%	0 0.0%	0 0.0%	0 0.0%	3 8.1%	0 0.0%

4. Primary Outcome

Title	Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Description	Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, prothrombin international (Intl.) normalized ratio, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal.
Time Frame	From Week 16 to Week 40

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period, with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time from week 16 to week 40.

Arm/Group Title		Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.	This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Overall Number of Participants Analyzed		19	18	10	9	12	9	37	38
Measure Type: Count of Participants; Unit of Measure: Participants
HGB (g/dL) <0.8*LLN	Number Analyzed	19 participants	17 participants	10 participants	9 participants	12 participants	9 participants	37 participants	38 participants
		0 0.0%	1 5.9%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.7%	0 0.0%
Hematocrit (%) <0.8*LLN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	37 participants
		0 0.0%	1 5.6%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.7%	0 0.0%
Erythrocytes (10^6/mm^3) <0.8*LLN	Number Analyzed	18 participants	15 participants	7 participants	9 participants	12 participants	8 participants	35 participants	37 participants
		2 11.1%	2 13.3%	0 0.0%	2 22.2%	1 8.3%	0 0.0%	1 2.9%	0 0.0%
Reticulocytes (10^3/mm^3) <0.5*LLN	Number Analyzed	19 participants	17 participants	10 participants	9 participants	11 participants	8 participants	34 participants	36 participants
		0 0.0%	1 5.9%	0 0.0%	1 11.1%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Reticulocytes (10^3/mm^3) >1.5*ULN	Number Analyzed	19 participants	17 participants	10 participants	9 participants	11 participants	8 participants	34 participants	36 participants
		0 0.0%	1 5.9%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.8%
Ery. Mean Corpuscular Volume (um^3) <0.9*LLN	Number Analyzed	17 participants	15 participants	8 participants	9 participants	11 participants	7 participants	35 participants	36 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Ery. Mean Corpuscular Volume (um^3) >1.1*ULN	Number Analyzed	17 participants	15 participants	8 participants	9 participants	11 participants	7 participants	35 participants	36 participants
		1 5.9%	0 0.0%	1 12.5%	0 0.0%	0 0.0%	0 0.0%	1 2.9%	0 0.0%
Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN	Number Analyzed	18 participants	17 participants	10 participants	9 participants	11 participants	9 participants	36 participants	37 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Ery. Mean Corpuscular HGB (pg/cell) >1.1*ULN	Number Analyzed	18 participants	17 participants	10 participants	9 participants	11 participants	9 participants	36 participants	37 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Platelets (10^3/mm^3) <0.5*LLN	Number Analyzed	17 participants	18 participants	10 participants	9 participants	10 participants	9 participants	35 participants	37 participants
		0 0.0%	1 5.6%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Platelets (10^3/mm^3) >1.75*ULN	Number Analyzed	17 participants	18 participants	10 participants	9 participants	10 participants	9 participants	35 participants	37 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Reticulocytes/Erythrocytes (%) <0.5*LLN	Number Analyzed	19 participants	17 participants	10 participants	9 participants	11 participants	8 participants	33 participants	35 participants
		0 0.0%	1 5.9%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Reticulocytes/Erythrocytes (%) >1.5*ULN	Number Analyzed	19 participants	17 participants	10 participants	9 participants	11 participants	8 participants	33 participants	35 participants
		0 0.0%	2 11.8%	0 0.0%	1 11.1%	0 0.0%	0 0.0%	1 3.0%	2 5.7%
Leukocytes(10^3/mm^3) <0.6*LLN	Number Analyzed	18 participants	18 participants	10 participants	7 participants	11 participants	9 participants	35 participants	35 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Leukocytes(10^3/mm^3) >1.5*ULN	Number Analyzed	18 participants	18 participants	10 participants	7 participants	11 participants	9 participants	35 participants	35 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Lymphocytes/Leukocytes (%) <0.8*LLN	Number Analyzed	18 participants	18 participants	10 participants	6 participants	11 participants	8 participants	30 participants	36 participants
		0 0.0%	1 5.6%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.8%
Lymphocytes/Leukocytes (%) >1.2*ULN	Number Analyzed	18 participants	18 participants	10 participants	6 participants	11 participants	8 participants	30 participants	36 participants
		0 0.0%	5 27.8%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 6.7%	5 13.9%
Neutrophils/Leukocytes (%) <0.8*LLN	Number Analyzed	18 participants	18 participants	10 participants	6 participants	10 participants	8 participants	32 participants	37 participants
		1 5.6%	3 16.7%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 3.1%	3 8.1%
Neutrophils/Leukocytes (%) >1.2*ULN	Number Analyzed	18 participants	18 participants	10 participants	6 participants	10 participants	8 participants	32 participants	37 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Basophils (10^3/mm^3) >1.2*ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	36 participants	36 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Basophils/Leukocytes (%) >1.2*ULN	Number Analyzed	16 participants	18 participants	10 participants	8 participants	11 participants	8 participants	33 participants	31 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Eosinophils (10^3/mm^3) >1.2*ULN	Number Analyzed	19 participants	17 participants	10 participants	9 participants	12 participants	9 participants	37 participants	37 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.7%
Eosinophils/Leukocytes (%) >1.2*ULN	Number Analyzed	19 participants	18 participants	9 participants	9 participants	12 participants	9 participants	35 participants	36 participants
		0 0.0%	1 5.6%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Monocytes (10^3/mm^3) >1.2*ULN	Number Analyzed	19 participants	18 participants	10 participants	8 participants	12 participants	9 participants	37 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	1 12.5%	0 0.0%	0 0.0%	0 0.0%	1 2.6%
Monocytes/Leukocytes (%) >1.2*ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	37 participants
		2 10.5%	1 5.6%	1 10.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	3 8.1%
Activated Partial Thromboplastin Time (sec) >1.1 x ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	38 participants
		1 5.3%	0 0.0%	0 0.0%	1 11.1%	1 8.3%	0 0.0%	0 0.0%	0 0.0%
Prothrombin Time (sec) >1.1*ULN	Number Analyzed	18 participants	18 participants	9 participants	9 participants	12 participants	8 participants	37 participants	38 participants
		3 16.7%	0 0.0%	0 0.0%	1 11.1%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Prothrombin Intl. Normalized Ratio >1.1*ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Neutrophils total count (10^3/mm^3) <0.8*LLN	Number Analyzed	19 participants	18 participants	10 participants	7 participants	10 participants	9 participants	31 participants	35 participants
		1 5.3%	3 16.7%	1 10.0%	2 28.6%	2 20.0%	1 11.1%	7 22.6%	4 11.4%
Neutrophils total count (10^3/mm^3) >1.2*ULN	Number Analyzed	19 participants	18 participants	10 participants	7 participants	10 participants	9 participants	31 participants	35 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 3.2%	1 2.9%
Lymphocytes total count (10^3/mm^3) <0.8*LLN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	11 participants	9 participants	37 participants	38 participants
		0 0.0%	2 11.1%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.7%	0 0.0%
Lymphocytes total count (10^3/mm^3) >1.2*ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	11 participants	9 participants	37 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 11.1%	1 2.7%	0 0.0%

5. Primary Outcome

Title	Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Description	Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol.
Time Frame	From Week 16 to Week 40

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period, with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time from week 16 to week 40.

Arm/Group Title		Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.	This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Overall Number of Participants Analyzed		19	18	10	9	12	9	37	38
Measure Type: Count of Participants; Unit of Measure: Participants
Bilirubin (mg/dL) >1.5*ULN	Number Analyzed	18 participants	18 participants	10 participants	9 participants	12 participants	8 participants	35 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.9%	0 0.0%
Direct Bilirubin (mg/dL) >1.5*ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Indirect Bilirubin (mg/dL) >1.5*ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	8 participants	35 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Aspartate Aminotransferase (U/L) > 3.0*ULN	Number Analyzed	19 participants	17 participants	8 participants	9 participants	12 participants	9 participants	34 participants	31 participants
		0 0.0%	1 5.9%	0 0.0%	0 0.0%	0 0.0%	1 11.1%	1 2.9%	2 6.5%
Alanine Aminotransferase (U/L) > 3.0*ULN	Number Analyzed	18 participants	16 participants	7 participants	8 participants	11 participants	8 participants	33 participants	25 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 6.1%	0 0.0%
Gamma Glutamyl Transferase (U/L) > 3.0*ULN	Number Analyzed	17 participants	15 participants	9 participants	9 participants	10 participants	9 participants	33 participants	31 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 6.1%	0 0.0%
Alkaline Phosphatase (U/L) > 3.0*ULN	Number Analyzed	17 participants	17 participants	9 participants	8 participants	11 participants	9 participants	35 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Protein (g/dL) <0.8*LLN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Protein (g/dL) >1.2*ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Albumin (g/dL) <0.8*LLN	Number Analyzed	18 participants	16 participants	7 participants	9 participants	10 participants	8 participants	34 participants	33 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Albumin (g/dL) >1.2*ULN	Number Analyzed	18 participants	16 participants	7 participants	9 participants	10 participants	8 participants	34 participants	33 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Blood Urea Nitrogen (mg/dL) >1.3*ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	37 participants
		1 5.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Urea (mg/dL) >1.3*ULN	Number Analyzed	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	1 participants
		0	0	0	0	0 0.0%	0	0	0 0.0%
Creatinine (mg/dL) >1.3*ULN	Number Analyzed	19 participants	18 participants	9 participants	9 participants	12 participants	9 participants	37 participants	37 participants
		0 0.0%	1 5.6%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.7%
Urate (mg/dL) >1.2*ULN	Number Analyzed	17 participants	17 participants	9 participants	9 participants	12 participants	9 participants	34 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.6%
HDL Cholesterol (mg/dL) <0.8*LLN	Number Analyzed	16 participants	15 participants	9 participants	8 participants	9 participants	8 participants	33 participants	32 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
LDL Cholesterol (mg/dL) >1.2*ULN	Number Analyzed	16 participants	14 participants	10 participants	8 participants	9 participants	8 participants	33 participants	30 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Triglycerides (mg/dL) >1.3*ULN	Number Analyzed	16 participants	15 participants	8 participants	8 participants	9 participants	8 participants	33 participants	32 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 12.5%	0 0.0%	1 3.1%
Sodium (Meq/L) <0.95*LLN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Sodium (Meq/L) >1.05*ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Potassium (Meq/L) <0.9*LLN	Number Analyzed	19 participants	18 participants	9 participants	9 participants	12 participants	9 participants	37 participants	37 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Potassium (Meq/L) >1.1*ULN	Number Analyzed	19 participants	18 participants	9 participants	9 participants	12 participants	9 participants	37 participants	37 participants
		1 5.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.7%
Chloride (Meq/L) <0.9*LLN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	37 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Chloride (Meq/L) >1.1*ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	37 participants	37 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Calcium (mg/dL) <0.9*LLN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	36 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Calcium (mg/dL) >1.1*ULN	Number Analyzed	19 participants	18 participants	10 participants	9 participants	12 participants	9 participants	36 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Bicarbonate (Meq/L) <0.9*LLN	Number Analyzed	19 participants	17 participants	9 participants	9 participants	12 participants	9 participants	37 participants	37 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Bicarbonate (Meq/L) >1.1*ULN	Number Analyzed	19 participants	17 participants	9 participants	9 participants	12 participants	9 participants	37 participants	37 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Glucose (mg/dL) <0.6*LLN	Number Analyzed	10 participants	13 participants	7 participants	6 participants	10 participants	6 participants	19 participants	25 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Glucose (mg/dL) >1.5*ULN	Number Analyzed	10 participants	13 participants	7 participants	6 participants	10 participants	6 participants	19 participants	25 participants
		1 10.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	3 15.8%	2 8.0%
Creatine Kinase (U/L) >2.0*ULN	Number Analyzed	17 participants	18 participants	9 participants	9 participants	12 participants	8 participants	36 participants	35 participants
		2 11.8%	6 33.3%	2 22.2%	5 55.6%	2 16.7%	3 37.5%	5 13.9%	12 34.3%
Cholesterol (mg/dL) >1.3*ULN	Number Analyzed	15 participants	14 participants	9 participants	7 participants	9 participants	8 participants	30 participants	32 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

6. Primary Outcome

Title	Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Description	Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria.
Time Frame	From Week 16 to Week 40

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period, with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time from week 16 to week 40.

Arm/Group Title		Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.	This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Overall Number of Participants Analyzed		19	18	10	9	12	9	37	38
Measure Type: Count of Participants; Unit of Measure: Participants
Urine pH (Scalar) <4.5	Number Analyzed	16 participants	13 participants	10 participants	8 participants	9 participants	8 participants	33 participants	32 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Urine pH (Scalar) >8	Number Analyzed	16 participants	13 participants	10 participants	8 participants	9 participants	8 participants	33 participants	32 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Urine Glucose >=1	Number Analyzed	15 participants	12 participants	9 participants	8 participants	8 participants	8 participants	32 participants	32 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 3.1%
Urine Ketones (Scalar) >=1	Number Analyzed	16 participants	12 participants	10 participants	8 participants	9 participants	7 participants	32 participants	31 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Urine Protein >=1	Number Analyzed	16 participants	13 participants	10 participants	8 participants	9 participants	8 participants	33 participants	32 participants
		1 6.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 3.0%	0 0.0%
Urine Hemoglobin (Scalar) >=1	Number Analyzed	16 participants	12 participants	10 participants	8 participants	9 participants	8 participants	33 participants	31 participants
		0 0.0%	1 8.3%	1 10.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 6.5%
Urine Urobilinogen (EU/dL) >=1	Number Analyzed	16 participants	13 participants	10 participants	8 participants	8 participants	8 participants	33 participants	32 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 6.1%	0 0.0%
Urine Bilirubin (Scalar) >=1	Number Analyzed	16 participants	13 participants	10 participants	8 participants	9 participants	8 participants	33 participants	32 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Urine Nitrite (Scalar) >=1	Number Analyzed	16 participants	12 participants	10 participants	8 participants	9 participants	8 participants	33 participants	31 participants
		2 12.5%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Urine Leukocyte Esterase (Scalar) >=1	Number Analyzed	15 participants	12 participants	10 participants	7 participants	9 participants	8 participants	32 participants	32 participants
		2 13.3%	1 8.3%	0 0.0%	1 14.3%	0 0.0%	1 12.5%	2 6.3%	0 0.0%
Urine Erythrocytes (Scalar) >=20	Number Analyzed	4 participants	5 participants	2 participants	2 participants	3 participants	1 participants	3 participants	9 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Urine Leukocytes (/HPF) >=20	Number Analyzed	4 participants	4 participants	2 participants	1 participants	3 participants	1 participants	8 participants	14 participants
		1 25.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 100.0%	0 0.0%	0 0.0%
Urine Hyaline Casts (/LPF) >1	Number Analyzed	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants
						0 0.0%
Urine Bacteria (/LPF) >20	Number Analyzed	3 participants	0 participants	0 participants	1 participants	0 participants	0 participants	1 participants	0 participants
		0 0.0%			0 0.0%			0 0.0%

7. Primary Outcome

Title	Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
Description	Criteria for ECG abnormalities: maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 milliseconds (msec) and Pctchg>=50% for baseline value of <=200 msec for PR interval, a maximum IFB: Pctchg>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to <=480 msec, 480 msec to <=500 msec and a maximum change of <30 change =<60 or >60 msec from baseline.
Time Frame	From Week 16 to Week 40

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and were treated in the extension treatment period and evaluated against criteria.

Arm/Group Title		Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.	This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Overall Number of Participants Analyzed		17	17	10	9	11	8	37	36
Measure Type: Count of Participants; Unit of Measure: Participants
PR interval, single beat (msec) Pctchg >=25/50%	Number Analyzed	17 participants	17 participants	10 participants	9 participants	10 participants	7 participants	37 participants	36 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 10.0%	0 0.0%	0 0.0%	0 0.0%
QRS duration, singe beat (msec) Pctchg >=50%	Number Analyzed	17 participants	17 participants	10 participants	9 participants	11 participants	8 participants	37 participants	36 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 9.1%	0 0.0%	0 0.0%	0 0.0%
QT interval, single beat (msec) >500	Number Analyzed	17 participants	17 participants	10 participants	9 participants	11 participants	8 participants	37 participants	36 participants
		0 0.0%	0 0.0%	1 10.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
450< QTcF - Fridericia's correction formula (msec) <=480	Number Analyzed	17 participants	17 participants	10 participants	9 participants	11 participants	8 participants	37 participants	36 participants
		0 0.0%	0 0.0%	1 10.0%	0 0.0%	1 9.1%	0 0.0%	1 2.7%	0 0.0%
480< QTcF - Fridericia's correction formula (msec) <=500	Number Analyzed	17 participants	17 participants	10 participants	9 participants	11 participants	8 participants	37 participants	36 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 9.1%	0 0.0%	0 0.0%	0 0.0%
30< QTcF - Fridericia's correction formula (msec) change <=60	Number Analyzed	17 participants	17 participants	10 participants	9 participants	11 participants	8 participants	37 participants	36 participants
		1 5.9%	0 0.0%	0 0.0%	0 0.0%	2 18.2%	0 0.0%	3 8.1%	1 2.8%
QTcF - Fridericia's correction formula (msec) change >60	Number Analyzed	17 participants	17 participants	10 participants	9 participants	11 participants	8 participants	37 participants	36 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 9.1%	0 0.0%	0 0.0%	0 0.0%

8. Primary Outcome

Title	Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
Description	The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: sitting diastolic blood pressure (BP) < 50 millimeter of mercury (mmHg), sitting diastolic BP change >= 20 mmHg increase, sitting diastolic BP change >= 20 mmHg decrease, sitting systolic BP < 90 mmHg, sitting systolic BP change >= 30 mmHg increase, and sitting systolic BP change >= 30 mmHg decrease.
Time Frame	From Week 16 to Week 40

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who entered the extension treatment period.

Arm/Group Title	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Arm/Group Description:	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.	This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Overall Number of Participants Analyzed	19	18	10	9	12	9	37	38
Measure Type: Count of Participants; Unit of Measure: Participants
Sitting diastolic BP (mmHg) <50	0 0.0%	1 5.6%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Sitting diastolic BP (mmHg) change >= 20 increase	0 0.0%	1 5.6%	1 10.0%	0 0.0%	0 0.0%	0 0.0%	4 10.8%	4 10.5%
Sitting diastolic BP (mmHg) change >= 20 decrease	1 5.3%	1 5.6%	0 0.0%	2 22.2%	0 0.0%	0 0.0%	3 8.1%	4 10.5%
Sitting systolic BP (mmHg) <90	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.7%	0 0.0%
Sitting systolic BP (mmHg) change >= 30 increase	0 0.0%	0 0.0%	0 0.0%	1 11.1%	0 0.0%	2 22.2%	4 10.8%	5 13.2%
Sitting systolic BP (mmHg) change >= 30 decrease	0 0.0%	2 11.1%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.7%	1 2.6%

9. Secondary Outcome

Title	Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period
Description	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. The statistical analysis was for the data at Week 16.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).

Arm/Group Title	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed	42	22	21	45	41
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
Week 1	0; (0.00 to 6.41)	0; (0.00 to 12.60)	0; (0.00 to 12.33)	2.2; (0.23 to 9.17)	0; (0.00 to 6.57)
Week 2	4.8; (1.27 to 13.53)	0; (0.00 to 12.60)	0; (0.00 to 12.33)	8.9; (3.93 to 18.01)	2.4; (0.26 to 10.10)
Week 4	7.1; (2.56 to 17.39)	4.5; (0.48 to 19.56)	0; (0.00 to 12.33)	24.4; (15.47 to 35.88)	31.7; (19.88 to 44.52)
Week 6	7.1; (2.56 to 17.39)	13.6; (5.12 to 31.13)	4.8; (0.50 to 20.57)	33.3; (21.80 to 46.08)	43.9; (31.18 to 57.87)
Week 8	4.8; (1.27 to 15.53)	13.6; (5.12 to 31.13)	14.3; (5.37 to 32.81)	40.0; (28.66 to 52.89)	61.0; (46.94 to 73.77)
Week 12	9.5; (4.22 to 19.38)	13.6; (5.12 to 31.13)	9.5; (2.56 to 24.50)	51.1; (38.26 to 64.12)	70.7; (57.87 to 82.16)
Week 16	14.3; (6.41 to 25.56)	18.2; (8.17 to 35.25)	9.5; (2.56 to 24.50)	46.7; (33.79 to 59.13)	73.2; (60.23 to 82.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 50 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	3.90
	Confidence Interval	(2-Sided) 90%; -11.82 to 23.42
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 100 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-4.76
	Confidence Interval	(2-Sided) 90%; -18.61 to 13.29
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 200 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	32.38
	Confidence Interval	(2-Sided) 90%; 14.32 to 47.52
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 400 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	58.89
	Confidence Interval	(2-Sided) 90%; 41.01 to 72.41
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period
Description	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). The statistical analysis was for the data at Week 16.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).

Arm/Group Title	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed	42	22	21	45	41
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
Week 1	2.4; (0.25 to 9.85)	0; (0.00 to 12.60)	4.8; (0.50 to 20.57)	4.4; (1.19 to 12.58)	4.9; (1.30 to 13.87)
Week 2	2.4; (0.25 to 9.85)	0; (0.00 to 12.60)	4.8; (0.50 to 20.57)	11.1; (5.50 to 21.80)	7.3; (2.72 to 17.32)
Week 4	9.5; (4.22 to 19.38)	9.1; (2.44 to 23.60)	4.8; (0.50 to 20.57)	35.6; (23.73 to 48.68)	36.6; (24.57 to 50.00)
Week 6	14.3; (6.41 to 25.56)	13.6; (5.12 to 31.13)	14.3; (5.37 to 32.81)	46.7; (33.79 to 59.13)	53.7; (39.77 to 66.11)
Week 8	14.3; (6.41 to 25.56)	18.2; (8.17 to 35.25)	14.3; (5.37 to 32.81)	44.4; (31.73 to 56.75)	63.4; (50.00 to 75.43)
Week 12	14.3; (6.41 to 25.56)	18.2; (8.17 to 35.25)	19.0; (8.58 to 37.19)	46.7; (33.79 to 59.13)	78.0; (64.86 to 87.04)
Week 16	16.7; (9.06 to 27.68)	18.2; (8.17 to 35.25)	14.3; (5.37 to 32.81)	44.4; (31.73 to 56.75)	70.7; (57.87 to 82.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 50 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.52
	Confidence Interval	(2-Sided) 90%; -14.52 to 20.77
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 100 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-2.38
	Confidence Interval	(2-Sided) 90%; -17.67 to 17.01
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 200 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	27.78
	Confidence Interval	(2-Sided) 90%; 8.86 to 43.26
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 400 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	54.07
	Confidence Interval	(2-Sided) 90%; 36.46 to 68.27
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period
Description	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). The statistical analysis was for the data at Week 16.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).

Arm/Group Title	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed	42	22	21	45	41
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
Week 1	2.4; (0.25 to 9.85)	0; (0.00 to 12.60)	4.8; (0.50 to 20.57)	4.4; (1.19 to 12.58)	4.9; (1.30 to 13.87)
Week 2	2.4; (0.25 to 9.85)	0; (0.00 to 12.60)	4.8; (0.50 to 20.57)	11.1; (5.50 to 21.80)	7.3; (2.72 to 17.32)
Week 4	9.5; (4.22 to 19.38)	9.1; (2.44 to 23.60)	4.8; (0.50 to 20.57)	35.6; (23.73 to 48.68)	36.6; (24.57 to 50.00)
Week 6	14.3; (6.41 to 25.56)	13.6; (5.12 to 31.13)	14.3; (5.37 to 32.81)	46.7; (33.79 to 59.13)	53.7; (39.77 to 66.11)
Week 8	14.3; (6.41 to 25.56)	18.2; (8.17 to 35.25)	14.3; (5.37 to 32.81)	44.4; (31.73 to 56.75)	63.4; (50.00 to 75.43)
Week 12	14.3; (6.41 to 25.56)	18.2; (8.17 to 35.25)	19.0; (8.58 to 37.19)	46.7; (33.79 to 59.13)	78.0; (64.86 to 87.04)
Week 16	16.7; (9.06 to 27.68)	18.2; (8.17 to 35.25)	14.3; (5.37 to 32.81)	44.4; (31.73 to 56.75)	70.7; (57.87 to 82.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 50 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.52
	Confidence Interval	(2-Sided) 90%; -14.52 to 20.77
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 100 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-2.38
	Confidence Interval	(2-Sided) 90%; -17.67 to 17.01
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 200 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	27.78
	Confidence Interval	(2-Sided) 90%; 8.86 to 43.26
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 400 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	54.07
	Confidence Interval	(2-Sided) 90%; 36.46 to 68.27
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period
Description	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who were evaluated against criteria.

Arm/Group Title		Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed		42	22	21	45	41
Measure Type: Number; Unit of Measure: Percentage of participants
Week 1	Number Analyzed	42 participants	22 participants	21 participants	44 participants	40 participants
		2.4	0	4.8	11.4	5.0
Week 2	Number Analyzed	42 participants	22 participants	21 participants	45 participants	41 participants
		7.1	13.6	4.8	28.9	22.0
Week 4	Number Analyzed	40 participants	21 participants	21 participants	44 participants	40 participants
		22.5	19.0	14.3	50.0	65.0
Week 6	Number Analyzed	38 participants	21 participants	20 participants	44 participants	39 participants
		28.9	33.3	30.0	59.1	69.2
Week 8	Number Analyzed	37 participants	20 participants	20 participants	41 participants	40 participants
		32.4	35.0	25.0	70.7	75.0
Week 12	Number Analyzed	36 participants	20 participants	21 participants	41 participants	40 participants
		38.9	45.0	38.1	73.2	92.5
Week 16	Number Analyzed	36 participants	20 participants	20 participants	38 participants	39 participants
		41.7	45.0	45.0	68.4	94.9

13. Secondary Outcome

Title	Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period
Description	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 100 response was defined as at least a 100 percent (%) reduction in PASI relative to Baseline.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who were evaluated against criteria.

Arm/Group Title		Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed		42	22	21	45	41
Measure Type: Number; Unit of Measure: Percentage of participants
Week 1	Number Analyzed	42 participants	22 participants	21 participants	44 participants	40 participants
		0	0	0	0	0
Week 2	Number Analyzed	42 participants	22 participants	21 participants	45 participants	41 participants
		0	0	0	2.2	0
Week 4	Number Analyzed	40 participants	21 participants	21 participants	44 participants	40 participants
		0	0	0	4.5	0
Week 6	Number Analyzed	38 participants	21 participants	20 participants	44 participants	39 participants
		0	4.8	0	9.1	7.7
Week 8	Number Analyzed	37 participants	20 participants	20 participants	41 participants	40 participants
		0	5.0	0	17.1	15.0
Week 12	Number Analyzed	36 participants	20 participants	21 participants	41 participants	40 participants
		0	5.0	4.8	12.2	22.5
Week 16	Number Analyzed	36 participants	20 participants	20 participants	38 participants	39 participants
		0	15.0	5.0	15.8	20.5

14. Secondary Outcome

Title	Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Description	Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The statistical analysis was for the data at Week 16.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.

Arm/Group Title		Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed		42	22	21	45	41
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
Week 1	Number Analyzed	42 participants	22 participants	21 participants	44 participants	40 participants
		-1.88 (0.697)	-2.82 (0.969)	-1.96 (0.984)	-4.32 (0.676)	-3.00 (0.708)
Week 2	Number Analyzed	42 participants	22 participants	21 participants	45 participants	41 participants
		-3.44 (0.959)	-3.83 (1.330)	-3.24 (1.356)	-0.804 (0.926)	-7.40 (0.970)
Week 4	Number Analyzed	40 participants	21 participants	21 participants	44 participants	40 participants
		-5.08 (1.108)	-5.16 (1.528)	-4.68 (1.553)	-12.25 (1.065)	-12.16 (1.114)
Week 6	Number Analyzed	38 participants	21 participants	20 participants	44 participants	39 participants
		-6.02 (1.268)	-6.96 (1.737)	-7.53 (1.769)	-14.45 (1.212)	-14.78 (1.268)
Week 8	Number Analyzed	37 participants	20 participants	20 participants	41 participants	40 participants
		-7.43 (1.333)	-7.55 (1.827)	-9.29 (1.847)	-15.74 (1.274)	-17.12 (1.324)
Week 12	Number Analyzed	36 participants	20 participants	21 participants	41 participants	40 participants
		-8.09 (1.364)	-8.58 (1.863)	-10.02 (1.861)	-16.79 (1.300)	-19.69 (1.340)
Week 16	Number Analyzed	36 participants	20 participants	20 participants	38 participants	39 participants
		-7.88 (1.417)	-9.34 (1.932)	-11.42 (1.928)	-17.68 (1.354)	-20.21 (1.387)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 50 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.46
	Confidence Interval	(2-Sided) 90%; -5.42 to 2.51
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 100 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.54
	Confidence Interval	(2-Sided) 90%; -7.50 to 0.42
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 200 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.80
	Confidence Interval	(2-Sided) 90%; -13.05 to -6.56
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 400 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-12.33
	Confidence Interval	(2-Sided) 90%; -15.61 to -9.04
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Description	Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The statistical analysis was for the data at Week 16.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.

Arm/Group Title		Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed		42	22	21	45	41
Least Squares Mean (Standard Error); Unit of Measure: Percent change
Week 1	Number Analyzed	42 participants	22 participants	21 participants	44 participants	40 participants
		-5.63 (2.858)	-9.42 (3.975)	-8.93 (4.039)	-17.41 (2.774)	-12.55 (2.908)
Week 2	Number Analyzed	42 participants	22 participants	21 participants	45 participants	41 participants
		-16.18 (3.809)	-14.80 (5.283)	-14.37 (5.385)	-33.65 (3.677)	-30.58 (3.851)
Week 4	Number Analyzed	40 participants	21 participants	21 participants	44 participants	40 participants
		-22.66 (4.437)	-20.88 (6.107)	-22.70 (6.205)	-51.26 (4.259)	-53.81 (4.449)
Week 6	Number Analyzed	38 participants	21 participants	20 participants	44 participants	39 participants
		-27.07 (4.833)	-30.25 (6.619)	-33.79 (6.739)	-60.63 (4.620)	-64.03 (4.828)
Week 8	Number Analyzed	37 participants	20 participants	20 participants	41 participants	40 participants
		-31.16 (4.983)	-33.27 (6.831)	-39.81 (6.909)	-66.51 (4.763)	-72.81 (4.954)
Week 12	Number Analyzed	36 participants	20 participants	21 participants	41 participants	40 participants
		-32.66 (5.137)	-37.24 (7.010)	-42.25 (6.996)	-70.28 (4.886)	-84.17 (5.039)
Week 16	Number Analyzed	36 participants	20 participants	20 participants	38 participants	39 participants
		-33.29 (5.369)	-41.92 (7.304)	-46.31 (7.271)	-74.03 (5.122)	-86.33 (5.236)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 50 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.63
	Confidence Interval	(2-Sided) 90%; -23.61 to 6.35
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 100 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-13.02
	Confidence Interval	(2-Sided) 90%; -27.98 to 1.94
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 200 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-40.74
	Confidence Interval	(2-Sided) 90%; -53.02 to -28.46
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 400 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-53.04
	Confidence Interval	(2-Sided) 90%; -65.44 to -40.63
	Estimation Comments	[Not Specified]

16. Secondary Outcome

Title	Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
Description	The intensity of pruritus was assessed by a PP-NRS, an 11-category numeric rating scale from 0 to 10, which was participant reported. Participants were asked to assess their itch over the past 24 hours, anchored by the terms "no itch" (0) and "worst itch imaginable" (10) at the ends. The statistical analysis was for the data at Week 16.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.

Arm/Group Title		Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed		38	17	20	42	38
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
Study Day 2, Week 1	Number Analyzed	38 participants	17 participants	19 participants	41 participants	37 participants
		-0.60 (0.238)	0.05 (0.355)	-0.64 (0.331)	-0.76 (0.229)	-0.41 (0.241)
Study Day 3, Week 1	Number Analyzed	38 participants	17 participants	20 participants	40 participants	38 participants
		-0.71 (0.239)	-0.65 (0.354)	-0.90 (0.325)	-0.83 (0.230)	-0.88 (0.239)
Study Day 4, Week 1	Number Analyzed	38 participants	17 participants	19 participants	41 participants	37 participants
		-0.76 (0.234)	-0.83 (0.348)	-0.89 (0.323)	-1.24 (0.224)	-1.04 (0.236)
Study Day 5, Week 1	Number Analyzed	38 participants	16 participants	18 participants	41 participants	35 participants
		-0.63 (0.233)	-0.91 (0.348)	-1.12 (0.324)	-1.26 (0.223)	-1.08 (0.237)
Study Day 6, Week 1	Number Analyzed	38 participants	17 participants	19 participants	41 participants	34 participants
		-0.82 (0.246)	-0.94 (0.362)	-0.81 (0.336)	-1.49 (0.235)	-1.34 (0.250)
Study Day 7, Week 1	Number Analyzed	37 participants	17 participants	18 participants	38 participants	37 participants
		-0.72 (0.272)	-1.11 (0.399)	-0.86 (0.372)	-1.75 (0.261)	-1.11 (0.273)
Study Day 8, Week 1	Number Analyzed	37 participants	16 participants	20 participants	42 participants	37 participants
		-0.83 (0.274)	-1.26 (0.403)	-0.92 (0.371)	-1.65 (0.261)	-1.21 (0.276)
Study Day 9, Week 1	Number Analyzed	37 participants	17 participants	18 participants	39 participants	37 participants
		-0.79 (0.289)	-1.32 (0.425)	-1.08 (0.394)	-1.50 (0.278)	-1.43 (0.292)
Study Day 10, Week 1	Number Analyzed	37 participants	16 participants	20 participants	40 participants	36 participants
		-0.85 (0.284)	-1.48 (0.420)	-1.01 (0.384)	-1.63 (0.272)	-1.46 (0.286)
Study Day 11, Week 1	Number Analyzed	33 participants	15 participants	19 participants	37 participants	36 participants
		-0.70 (0.291)	-1.55 (0.429)	-1.11 (0.392)	-1.67 (0.278)	-1.27 (0.291)
Study Day 12, Week 2	Number Analyzed	32 participants	16 participants	18 participants	38 participants	35 participants
		-0.63 (0.289)	-1.67 (0.424)	-0.92 (0.390)	-1.93 (0.275)	-1.39 (0.289)
Study Day 13, Week 2	Number Analyzed	34 participants	16 participants	19 participants	41 participants	33 participants
		-0.78 (0.294)	-1.49 (0.433)	-1.15 (0.397)	-2.18 (0.280)	-1.61 (0.296)
Study Day 14, Week 2	Number Analyzed	34 participants	17 participants	20 participants	38 participants	36 participants
		-0.82 (0.317)	-1.66 (0.464)	-1.21 (0.426)	-2.15 (0.302)	-1.81 (0.317)
Study Day 15, Week 2	Number Analyzed	36 participants	16 participants	19 participants	40 participants	38 participants
		-0.75 (0.308)	-1.48 (0.454)	-1.18 (0.417)	-2.20 (0.294)	-1.83 (0.309)
Study Day 16, Week 2	Number Analyzed	34 participants	16 participants	18 participants	37 participants	37 participants
		-0.73 (0.314)	-1.52 (0.462)	-1.13 (0.426)	-2.29 (0.301)	-1.80 (0.314)
Week 4	Number Analyzed	36 participants	17 participants	20 participants	41 participants	37 participants
		-0.54 (0.354)	-1.74 (0.517)	-1.64 (0.477)	-2.90 (0.337)	-2.57 (0.354)
Week 8	Number Analyzed	34 participants	17 participants	20 participants	37 participants	38 participants
		-1.24 (0.391)	-1.10 (0.561)	-1.93 (0.517)	-4.10 (0.374)	-4.12 (0.381)
Week 12	Number Analyzed	34 participants	17 participants	20 participants	38 participants	37 participants
		-0.84 (0.455)	-1.66 (0.651)	-2.18 (0.599)	-3.92 (0.433)	-4.27 (0.442)
Week 16	Number Analyzed	33 participants	17 participants	18 participants	35 participants	36 participants
		-0.93 (0.453)	-2.15 (0.645)	-2.14 (0.604)	-4.40 (0.435)	-4.59 (0.440)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 50 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.22
	Confidence Interval	(2-Sided) 90%; -2.52 to 0.09
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 100 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.21
	Confidence Interval	(2-Sided) 90%; -2.46 to 0.05
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 200 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.47
	Confidence Interval	(2-Sided) 90%; -4.51 to -2.43
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 400 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.66
	Confidence Interval	(2-Sided) 90%; -4.71 to -2.61
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
Description	The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The statistical analysis was for the data at Week 16.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).

Arm/Group Title	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed	42	22	21	45	41
Measure Type: Number; Number (90% Confidence Interval); Unit of Measure: Percentage of participants
Study Day 2, Week 1	7.1; (2.65 to 17.39)	0; (0.00 to 12.60)	4.8; (0.50 to 20.57)	6.7; (2.47 to 16.17)	12.2; (6.05 to 23.04)
Study Day 3, Week 1	7.1; (2.65 to 17.39)	0; (0.00 to 12.60)	19.0; (8.58 to 37.19)	6.7; (2.47 to 16.17)	12.2; (6.05 to 23.04)
Study Day 4, Week 1	9.5; (4.22 to 19.38)	4.5; (0.48 to 19.56)	14.3; (5.37 to 32.81)	13.3; (5.97 to 23.73)	14.6; (6.57 to 26.23)
Study Day 5, Week 1	7.1; (2.65 to 17.39)	9.1; (2.44 to 23.60)	14.3; (5.37 to 32.81)	15.6; (8.42 to 25.96)	19.5; (10.10 to 31.18)
Study Day 6, Week 1	4.8; (1.27 to 13.53)	13.6; (5.12 to 31.13)	19.0; (8.58 to 37.19)	20.0; (11.72 to 31.73)	19.5; (10.10 to 31.18)
Study Day 7, Week 1	9.5; (4.22 to 19.38)	9.1; (2.44 to 23.60)	19.0; (8.58 to 37.19)	17.8; (9.17 to 29.70)	19.5; (10.10 to 31.18)
Study Day 8, Week 1	11.9; (5.91 to 22.74)	9.1; (2.44 to 23.60)	14.3; (5.37 to 32.81)	20.0; (11.72 to 31.73)	19.5; (10.10 to 31.18)
Study Day 9, Week 1	9.5; (4.22 to 19.38)	9.1; (2.44 to 23.60)	9.5; (2.56 to 24.50)	20.0; (11.72 to 31.73)	22.0; (12.96 to 35.14)
Study Day 10, Week 1	11.9; (5.91 to 22.74)	4.5; (0.48 to 19.56)	19.0; (8.58 to 37.19)	24.4; (15.47 to 35.88)	19.5; (10.10 to 31.18)
Study Day 11, Week 1	9.5; (4.22 to 19.38)	4.5; (0.48 to 19.56)	19.0; (8.58 to 37.19)	20.0; (11.72 to 31.73)	26.8; (17.12 to 39.77)
Study Day 12, Week 2	4.8; (1.27 to 13.53)	4.5; (0.48 to 19.56)	19.0; (8.58 to 37.19)	22.2; (12.58 to 33.79)	29.3; (17.84 to 42.13)
Study Day 13, Week 2	11.9; (5.91 to 22.74)	18.2; (8.17 to 32.25)	14.3; (5.37 to 32.81)	40.0; (28.66 to 52.89)	26.8; (17.12 to 39.77)
Study Day 14, Week 2	11.9; (5.91 to 22.74)	22.7; (11.49 to 39.52)	14.3; (5.37 to 32.81)	33.3; (21.80 to 46.08)	34.1; (23.04 to 46.94)
Study Day 15, Week 2	4.8; (1.27 to 13.53)	9.1; (2.44 to 23.60)	14.3; (5.37 to 32.81)	33.3; (21.80 to 46.08)	29.3; (17.84 to 42.13)
Study Day 16, Week 2	14.3; (6.41 to 25.56)	13.6; (5.12 to 31.13)	9.5; (2.56 to 24.50)	24.4; (15.47 to 35.88)	39.0; (26.23 to 53.06)
Week 4	14.3; (6.41 to 25.56)	13.6; (5.12 to 31.13)	28.6; (13.24 to 46.41)	44.4; (31.73 to 56.75)	43.9; (31.18 to 57.87)
Week 8	11.9; (5.91 to 22.74)	22.7; (11.49 to 39.52)	23.8; (12.06 to 41.72)	53.3; (40.87 to 66.21)	63.4; (50.00 to 75.43)
Week 12	7.1; (2.65 to 17.39)	31.8; (18.11 to 50.00)	28.6; (13.24 to 46.41)	55.6; (43.25 to 68.27)	63.4; (50.00 to 75.43)
Week 16	14.3; (6.41 to 25.56)	27.3; (12.60 to 44.36)	38.1; (20.57 to 58.28)	55.6; (43.25 to 68.27)	63.4; (50.00 to 75.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 50 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	12.99
	Confidence Interval	(2-Sided) 90%; -4.52 to 32.87
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 100 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	23.81
	Confidence Interval	(2-Sided) 90%; 2.62 to 44.64
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 200 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	41.27
	Confidence Interval	(2-Sided) 90%; 23.47 to 56.18
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 400 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	49.13
	Confidence Interval	(2-Sided) 90%; 30.62 to 63.69
	Estimation Comments	[Not Specified]

18. Secondary Outcome

Title	Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
Description	The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The outcome of PSI is the sum of the scores for the 8 items. The total score range of PSI is 0-32. A negative change from baseline means a better outcome and the bigger score decrease means a better outcome. The statistical analysis was for the data at Week 16.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.

Arm/Group Title		Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed		38	18	21	42	39
Least Squares Mean (Standard Error); Unit of Measure: Unit on a scale
Study Day 2, Week 1	Number Analyzed	38 participants	18 participants	19 participants	42 participants	37 participants
		-1.51 (0.636)	-0.89 (0.927)	-1.98 (0.880)	-2.54 (0.605)	-1.25 (0.639)
Study Day 3, Week 1	Number Analyzed	38 participants	18 participants	21 participants	41 participants	38 participants
		-2.70 (0.653)	-1.95 (0.952)	-3.65 (0.879)	-3.45 (0.624)	-2.79 (0.650)
Study Day 4, Week 1	Number Analyzed	38 participants	17 participants	19 participants	41 participants	37 participants
		-2.88 (0.666)	-3.05 (0.985)	-3.95 (0.915)	-4.61 (0.637)	-4.28 (0.665)
Study Day 5, Week 1	Number Analyzed	38 participants	16 participants	18 participants	41 participants	35 participants
		-2.55 (0.692)	-3.18 (1.032)	-3.87 (0.959)	-5.40 (0.661)	-3.93 (0.696)
Study Day 6, Week 1	Number Analyzed	38 participants	17 participants	19 participants	41 participants	35 participants
		-3.01 (0.716)	-3.98 (1.058)	-3.94 (0.981)	-5.43 (0.684)	-4.77 (0.717)
Study Day 7, Week 1	Number Analyzed	37 participants	17 participants	18 participants	38 participants	38 participants
		-3.23 (0.770)	-4.34 (1.134)	-4.08 (1.059)	-6.42 (0.740)	-4.90 (0.763)
Study Day 8, Week 1	Number Analyzed	37 participants	16 participants	20 participants	42 participants	38 participants
		-3.27 (0.768)	-4.38 (1.137)	-4.65 (1.042)	-6.23 (0.731)	-5.67 (0.762)
Study Day 9, Week 1	Number Analyzed	37 participants	17 participants	18 participants	39 participants	38 participants
		-3.11 (0.788)	-3.95 (1.159)	-4.54 (1.078)	-5.71 (0.756)	-5.70 (0.782)
Study Day 10, Week 1	Number Analyzed	37 participants	17 participants	20 participants	40 participants	37 participants
		-3.29 (0.781)	-4.24 (1.150)	-4.15 (1.055)	-6.22 (0.747)	-6.02 (0.776)
Study Day 11, Week 1	Number Analyzed	33 participants	15 participants	19 participants	37 participants	37 participants
		-2.89 (0.825)	-4.72 (1.216)	-4.41 (1.111)	-7.06 (0.787)	-6.03 (0.812)
Study Day 12, Week 2	Number Analyzed	32 participants	16 participants	19 participants	38 participants	36 participants
		-3.04 (0.763)	-4.54 (1.118)	-4.65 (1.027)	-7.10 (0.726)	-6.62 (0.753)
Study Day 13, Week 2	Number Analyzed	34 participants	16 participants	19 participants	41 participants	34 participants
		-2.94 (0.781)	-5.61 (1.149)	-4.79 (1.055)	-7.94 (0.742)	-7.16 (0.776)
Study Day 14, Week 2	Number Analyzed	34 participants	17 participants	21 participants	38 participants	37 participants
		-3.25 (0.793)	-5.84 (1.162)	-5.22 (1.065)	-8.12 (0.757)	-7.09 (0.784)
Study Day 15, Week 2	Number Analyzed	36 participants	16 participants	20 participants	40 participants	39 participants
		-2.71 (0.830)	-4.98 (1.227)	-5.23 (1.123)	-7.84 (0.793)	-7.47 (0.821)
Study Day 16, Week 2	Number Analyzed	34 participants	16 participants	18 participants	37 participants	38 participants
		-3.27 (0.847)	-5.03 (1.250)	-4.83 (1.150)	-8.12 (0.810)	-7.45 (0.836)
Week 4	Number Analyzed	36 participants	17 participants	20 participants	41 participants	38 participants
		-2.53 (0.990)	-4.83 (1.449)	-6.58 (1.338)	-9.14 (0.943)	-9.02 (0.978)
Week 8	Number Analyzed	34 participants	17 participants	20 participants	37 participants	39 participants
		-3.45 (1.069)	-4.09 (1.536)	-7.30 (1.407)	-11.63 (1.022)	-12.19 (1.026)
Week 12	Number Analyzed	34 participants	17 participants	20 participants	38 participants	38 participants
		-2.27 (1.208)	-5.65 (1.722)	-7.35 (1.572)	-11.50 (1.146)	-13.42 (1.145)
Week 16	Number Analyzed	33 participants	17 participants	18 participants	35 participants	37 participants
		-1.87 (1.260)	-6.07 (1.782)	-8.31 (1.661)	-12.38 (1.205)	-12.68 (1.191)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 50 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.21
	Confidence Interval	(2-Sided) 90%; -7.82 to -0.59
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 100 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.44
	Confidence Interval	(2-Sided) 90%; -9.89 to -2.99
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 200 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-10.51
	Confidence Interval	(2-Sided) 90%; -13.40 to -7.62
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo QD Group, PF-06826647 400 mg QD Group
	Comments	The analysis was based on the data at Week 16.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-10.81
	Confidence Interval	(2-Sided) 90%; -13.68 to -7.94
	Estimation Comments	[Not Specified]

19. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period
Description	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo).

Arm/Group Title	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed	45	22	23	45	43
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with AEs	23 51.1%	13 59.1%	16 69.6%	28 62.2%	29 67.4%
Participants with SAEs	0 0.0%	1 4.5%	0 0.0%	1 2.2%	0 0.0%
Participants with severe AEs	1 2.2%	0 0.0%	1 4.3%	2 4.4%	3 7.0%
Participants discontinued from study due to AEs	1 2.2%	0 0.0%	0 0.0%	5 11.1%	3 7.0%
Participants discontinued study drug due to AE and continue study	0 0.0%	0 0.0%	0 0.0%	1 2.2%	0 0.0%
Participants with dose reduced or temporary discontinuation due to AEs	1 2.2%	1 4.5%	2 8.7%	3 6.7%	3 7.0%

20. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period
Description	Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug ((PF-06826647 or placebo). Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo).

Arm/Group Title	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed	45	22	23	45	43
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with AEs	4 8.9%	0 0.0%	4 17.4%	11 24.4%	8 18.6%
Participants with SAEs	0 0.0%	0 0.0%	0 0.0%	1 2.2%	0 0.0%
Participants with severe AEs	0 0.0%	0 0.0%	0 0.0%	2 4.4%	1 2.3%
Participants discontinued from study due to AEs	0 0.0%	0 0.0%	0 0.0%	4 8.9%	3 7.0%
Participants discontinued study drug due to AE and continue study	0 0.0%	0 0.0%	0 0.0%	1 2.2%	0 0.0%
Participants with dose reduced or temporary discontinuation due to AEs	0 0.0%	0 0.0%	0 0.0%	1 2.2%	1 2.3%

21. Secondary Outcome

Title	Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
Description	Criteria for ECG abnormalities: Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to <=480 msec, 480 msec to <=500 msec and a maximum change of <30change<=60 or >60 msec from baseline.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who had at least 1 ECG assessment.

Arm/Group Title	Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed	44	22	23	44	43
Measure Type: Count of Participants; Unit of Measure: Participants
PR interval, single beat (msec) >=300	1 2.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
PR interval, single beat (msec) Pctchg >=25/50%	0 0.0%	0 0.0%	2 8.7%	1 2.3%	0 0.0%
QRS duration, single beat (msec) >=140	1 2.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
QRS duration, single beat (msec) Pctchg >=50%	1 2.3%	0 0.0%	1 4.3%	0 0.0%	0 0.0%
450< QTcF- Fridericia's correction formula (msec) <=480	1 2.3%	0 0.0%	2 8.7%	2 4.5%	0 0.0%
480< QTcF- Fridericia's correction formula (msec) <=500	1 2.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
30< QTcF- Fridericia's correction formula (msec) change <=60	0 0.0%	1 4.5%	1 4.3%	1 2.3%	2 4.7%
QTcF- Fridericia's correction formula (msec) change >60	1 2.3%	0 0.0%	1 4.3%	0 0.0%	0 0.0%

22. Secondary Outcome

Title	Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
Description	The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: pulse rate >120 beats per minute (BPM), sitting diastolic blood pressure (BP) change >=20 millimeter of mercury (mmHg) increase, sitting diastolic BP change >=20 mmHg decrease, sitting systolic BP <90 mmHg, sitting systolic BP change >=30 mmHg increase, and sitting systolic BP change >=30 mmHg decrease.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and were evaluated against the criteria.

Arm/Group Title		Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed		45	22	23	45	43
Measure Type: Count of Participants; Unit of Measure: Participants
Pulse rate (BMP) >120	Number Analyzed	45 participants	22 participants	23 participants	45 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.3%
Sitting diastolic BP (mmHg) change >=20 increase	Number Analyzed	45 participants	21 participants	23 participants	45 participants	43 participants
		4 8.9%	3 14.3%	1 4.3%	4 8.9%	4 9.3%
Sitting diastolic BP (mmHg) change >=20 decrease	Number Analyzed	45 participants	21 participants	23 participants	45 participants	43 participants
		4 8.9%	2 9.5%	0 0.0%	2 4.4%	4 9.3%
Sitting systolic BP (mmHg) <90 increase	Number Analyzed	45 participants	21 participants	23 participants	45 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.3%
Sitting systolic BP (mmHg) change >=30 increase	Number Analyzed	45 participants	21 participants	23 participants	45 participants	43 participants
		0 0.0%	1 4.8%	2 8.7%	2 4.4%	2 4.7%
Sitting systolic BP (mmHg) change >=30 decrease	Number Analyzed	45 participants	21 participants	23 participants	45 participants	43 participants
		4 8.9%	0 0.0%	1 4.3%	1 2.2%	2 4.7%

23. Secondary Outcome

Title	Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Description	Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo), with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time up to week 16.

Arm/Group Title		Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed		45	22	23	45	43
Measure Type: Count of Participants; Unit of Measure: Participants
HGB (g/dL) <0.8*LLN	Number Analyzed	44 participants	22 participants	23 participants	45 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	2 4.4%	3 7.0%
Hematocrit (%) <0.8*LLN	Number Analyzed	45 participants	22 participants	23 participants	45 participants	42 participants
		0 0.0%	0 0.0%	0 0.0%	2 4.4%	3 7.1%
Erythrocytes (10^6/mm^3) <0.8*LLN	Number Analyzed	41 participants	19 participants	22 participants	42 participants	42 participants
		0 0.0%	0 0.0%	0 0.0%	1 2.4%	4 9.5%
Reticulocytes (10^3/mm^3) <0.5*LLN	Number Analyzed	44 participants	22 participants	21 participants	42 participants	41 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 4.9%
Reticulocytes (10^3/mm^3) >1.5*ULN	Number Analyzed	44 participants	22 participants	21 participants	42 participants	41 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 4.9%
Ery. Mean Corpuscular Volume (um^3) <0.9*LLN	Number Analyzed	38 participants	18 participants	20 participants	43 participants	41 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Ery. Mean Corpuscular Volume (um^3) >1.1*ULN	Number Analyzed	38 participants	18 participants	20 participants	43 participants	41 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.4%
Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN	Number Analyzed	43 participants	22 participants	22 participants	44 participants	42 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN	Number Analyzed	43 participants	22 participants	22 participants	44 participants	42 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN	Number Analyzed	45 participants	22 participants	23 participants	45 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN	Number Analyzed	45 participants	22 participants	23 participants	45 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Platelets (10^3/mm^3) <0.5*LLN	Number Analyzed	42 participants	22 participants	21 participants	42 participants	41 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.4%
Platelets (10^3/mm^3) >1.75*ULN	Number Analyzed	42 participants	22 participants	21 participants	42 participants	41 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Reticulocytes/Erythrocytes (%) <0.5*LLN	Number Analyzed	44 participants	22 participants	21 participants	41 participants	40 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 5.0%
Reticulocytes/Erythrocytes (%) >1.5*ULN	Number Analyzed	44 participants	22 participants	21 participants	41 participants	40 participants
		0 0.0%	0 0.0%	0 0.0%	1 2.4%	2 5.0%
Leukocytes(10^3/mm^3) <0.6*LLN	Number Analyzed	44 participants	20 participants	22 participants	41 participants	39 participants
		0 0.0%	0 0.0%	0 0.0%	1 2.4%	1 2.6%
Leukocytes(10^3/mm^3) >1.5*ULN	Number Analyzed	44 participants	20 participants	22 participants	41 participants	39 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Lymphocytes/Leukocytes (%) <0.8*LLN	Number Analyzed	44 participants	19 participants	21 participants	37 participants	39 participants
		0 0.0%	1 5.3%	0 0.0%	1 2.7%	3 7.7%
Lymphocytes/Leukocytes (%) >1.2*ULN	Number Analyzed	44 participants	19 participants	21 participants	37 participants	39 participants
		0 0.0%	0 0.0%	0 0.0%	3 8.1%	4 10.3%
Neutrophils/Leukocytes (%) <0.8*LLN	Number Analyzed	44 participants	19 participants	20 participants	39 participants	40 participants
		1 2.3%	0 0.0%	0 0.0%	2 5.1%	2 5.0%
Neutrophils/Leukocytes (%) >1.2*ULN	Number Analyzed	44 participants	19 participants	20 participants	39 participants	40 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Basophils (10^3/mm^3) >1.2*ULN	Number Analyzed	45 participants	22 participants	23 participants	44 participants	41 participants
		0 0.0%	0 0.0%	0 0.0%	1 2.3%	0 0.0%
Basophils/Leukocytes (%) >1.2*ULN	Number Analyzed	42 participants	21 participants	21 participants	41 participants	36 participants
		2 4.8%	1 4.8%	1 4.8%	1 2.4%	1 2.8%
Eosinophils (10^3/mm^3) >1.2*ULN	Number Analyzed	44 participants	22 participants	23 participants	45 participants	42 participants
		1 2.3%	1 4.5%	0 0.0%	0 0.0%	0 0.0%
Eosinophils/Leukocytes (%) >1.2*ULN	Number Analyzed	45 participants	21 participants	23 participants	43 participants	41 participants
		2 4.4%	1 4.8%	0 0.0%	0 0.0%	0 0.0%
Monocytes (10^3/mm^3) >1.2*ULN	Number Analyzed	45 participants	21 participants	23 participants	45 participants	42 participants
		1 2.2%	0 0.0%	1 4.3%	0 0.0%	0 0.0%
Monocytes/Leukocytes (%) >1.2*ULN	Number Analyzed	45 participants	22 participants	23 participants	45 participants	42 participants
		2 4.4%	0 0.0%	0 0.0%	1 2.2%	0 0.0%
Activated Partial Thromboplastin Time (sec) >1.1*ULN	Number Analyzed	45 participants	22 participants	23 participants	44 participants	42 participants
		1 2.2%	0 0.0%	0 0.0%	0 0.0%	1 2.4%
Prothrombin Time (sec) >1.1*ULN	Number Analyzed	43 participants	21 participants	22 participants	45 participants	43 participants
		1 2.3%	0 0.0%	0 0.0%	0 0.0%	3 7.0%
Neutrophils total count (10^3/mm^3) <0.8*LLN	Number Analyzed	45 participants	20 participants	21 participants	38 participants	39 participants
		1 2.2%	0 0.0%	2 9.5%	3 7.9%	4 10.3%
Neutrophils total count (10^3/mm^3) >1.2*ULN	Number Analyzed	45 participants	20 participants	21 participants	38 participants	39 participants
		3 6.7%	1 5.0%	1 4.8%	2 5.3%	2 5.1%
Lymphocytes total count (10^3/mm^3) <0.8*LLN	Number Analyzed	45 participants	22 participants	22 participants	45 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	1 2.2%	1 2.3%
Lymphocytes total count (10^3/mm^3) >1.2*ULN	Number Analyzed	45 participants	22 participants	22 participants	45 participants	43 participants
		0 0.0%	0 0.0%	1 4.5%	1 2.2%	1 2.3%

24. Secondary Outcome

Title	Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Description	Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol. LLN=lower limit of normal; ULN=upper limit of normal.
Time Frame	Baseline up to Week 16.

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo), with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time up to week 16.

Arm/Group Title		Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed		45	22	23	45	43
Measure Type: Count of Participants; Unit of Measure: Participants
Bilirubin (mg/dL) >1.5*ULN	Number Analyzed	44 participants	22 participants	22 participants	43 participants	42 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Indirect Bilirubin (mg/dL) >1.5*ULN	Number Analyzed	45 participants	22 participants	22 participants	43 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Aspartate Aminotransferase (U/L) > 3.0*ULN	Number Analyzed	43 participants	20 participants	23 participants	40 participants	36 participants
		1 2.3%	0 0.0%	1 4.3%	0 0.0%	0 0.0%
Alanine Aminotransferase (U/L) > 3.0*ULN	Number Analyzed	40 participants	18 participants	21 participants	38 participants	30 participants
		1 2.5%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Gamma Glutamyl Transferase (U/L) > 3.0*ULN	Number Analyzed	38 participants	21 participants	21 participants	41 participants	36 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Alkaline Phosphatase (U/L) > 3.0*ULN	Number Analyzed	41 participants	20 participants	22 participants	43 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Protein (g/dL) <0.8*LLN	Number Analyzed	45 participants	22 participants	23 participants	44 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Protein (g/dL) >1.2*ULN	Number Analyzed	45 participants	22 participants	23 participants	44 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Albumin (g/dL) <0.8*LLN	Number Analyzed	40 participants	19 participants	20 participants	41 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Albumin (g/dL) >1.2*ULN	Number Analyzed	40 participants	19 participants	20 participants	41 participants	38 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Blood Urea Nitrogen (mg/dL) >1.3*ULN	Number Analyzed	45 participants	22 participants	23 participants	45 participants	42 participants
		1 2.2%	0 0.0%	0 0.0%	2 4.4%	0 0.0%
Urea (mg/dL) >1.3*ULN	Number Analyzed	0 participants	0 participants	1 participants	0 participants	0 participants
				0 0.0%
Creatinine (mg/dL) >1.3*ULN	Number Analyzed	45 participants	21 participants	23 participants	45 participants	42 participants
		0 0.0%	0 0.0%	0 0.0%	1 2.2%	1 2.4%
Urate (mg/dL) >1.2*ULN	Number Analyzed	40 participants	20 participants	23 participants	41 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
HDL Cholesterol (mg/dL) <0.8*LLN	Number Analyzed	40 participants	21 participants	23 participants	43 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Triglycerides (mg/dL) >1.3*ULN	Number Analyzed	39 participants	20 participants	23 participants	43 participants	43 participants
		1 2.6%	0 0.0%	0 0.0%	0 0.0%	3 7.0%
Sodium (Meq/L) <0.95*LLN	Number Analyzed	45 participants	22 participants	23 participants	45 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Sodium (Meq/L) >1.05*ULN	Number Analyzed	45 participants	22 participants	23 participants	45 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Potassium (Meq/L) <0.9*LLN	Number Analyzed	45 participants	21 participants	23 participants	45 participants	41 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Potassium (Meq/L) >1.1*ULN	Number Analyzed	45 participants	21 participants	23 participants	45 participants	41 participants
		1 2.2%	0 0.0%	1 4.3%	0 0.0%	0 0.0%
Chloride (Meq/L) <0.9*LLN	Number Analyzed	45 participants	22 participants	23 participants	44 participants	42 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Chloride (Meq/L) >1.1*ULN	Number Analyzed	45 participants	22 participants	23 participants	44 participants	42 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Calcium (mg/dL) <0.9*LLN	Number Analyzed	45 participants	22 participants	23 participants	44 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Calcium (mg/dL) >1.1*ULN	Number Analyzed	45 participants	22 participants	23 participants	44 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Bicarbonate (Meq/L) <0.9*LLN	Number Analyzed	44 participants	21 participants	23 participants	45 participants	42 participants
		0 0.0%	0 0.0%	1 4.3%	0 0.0%	0 0.0%
Bicarbonate (Meq/L) >1.1*ULN	Number Analyzed	44 participants	21 participants	23 participants	45 participants	42 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Glucose (mg/dL) <0.6*LLN	Number Analyzed	29 participants	16 participants	18 participants	25 participants	27 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Glucose (mg/dL) >1.5*ULN	Number Analyzed	29 participants	16 participants	18 participants	25 participants	27 participants
		1 3.4%	0 0.0%	0 0.0%	0 0.0%	1 3.7%
Creatine Kinase (U/L) >2.0*ULN	Number Analyzed	42 participants	20 participants	22 participants	42 participants	40 participants
		3 7.1%	3 15.0%	2 9.1%	9 21.4%	15 37.5%
Cholesterol (mg/dL) >1.3*ULN	Number Analyzed	38 participants	20 participants	23 participants	38 participants	43 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

25. Secondary Outcome

Title	Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Description	Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo), with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time up to week 16.

Arm/Group Title		Placebo QD Group	PF-06826647 50 mg QD Group	PF-06826647 100 mg QD Group	PF-06826647 200 mg QD Group	PF-06826647 400 mg QD Group
Arm/Group Description:		This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Overall Number of Participants Analyzed		45	22	23	45	43
Measure Type: Count of Participants; Unit of Measure: Participants
Urine pH (Scalar) <4.5	Number Analyzed	39 participants	22 participants	23 participants	43 participants	41 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Urine pH (Scalar) >8	Number Analyzed	39 participants	22 participants	23 participants	43 participants	41 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Urine Glucose >=1	Number Analyzed	37 participants	21 participants	22 participants	42 participants	41 participants
		0 0.0%	0 0.0%	0 0.0%	1 2.4%	1 2.4%
Urine Ketones (Scalar) >=1	Number Analyzed	38 participants	22 participants	22 participants	40 participants	40 participants
		2 5.3%	0 0.0%	1 4.5%	0 0.0%	2 5.0%
Urine Protein >=1	Number Analyzed	39 participants	22 participants	23 participants	42 participants	41 participants
		1 2.6%	0 0.0%	0 0.0%	1 2.4%	2 4.9%
Urine Hemoglobin (Scalar) >=1	Number Analyzed	38 participants	22 participants	23 participants	43 participants	40 participants
		3 7.9%	1 4.5%	0 0.0%	4 9.3%	0 0.0%
Urine Urobilinogen (EU/dL) >=1	Number Analyzed	39 participants	22 participants	22 participants	43 participants	40 participants
		1 2.6%	0 0.0%	0 0.0%	1 2.3%	2 5.0%
Urine Bilirubin (Scalar) >=1	Number Analyzed	39 participants	22 participants	23 participants	43 participants	41 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Urine Nitrite (Scalar) >=1	Number Analyzed	38 participants	22 participants	23 participants	43 participants	40 participants
		0 0.0%	1 4.5%	0 0.0%	0 0.0%	0 0.0%
Urine Leukocyte Esterase (Scalar) >=1	Number Analyzed	37 participants	21 participants	23 participants	41 participants	41 participants
		1 2.7%	2 9.5%	0 0.0%	1 2.4%	0 0.0%
Urine Erythrocytes (Scalar) >=20	Number Analyzed	13 participants	5 participants	8 participants	12 participants	19 participants
		1 7.7%	0 0.0%	0 0.0%	1 8.3%	0 0.0%
Urine Leukocytes (/HPF) >=20	Number Analyzed	12 participants	6 participants	8 participants	18 participants	18 participants
		1 8.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Urine Hyaline Casts (/LPF) >1	Number Analyzed	1 participants	1 participants	0 participants	3 participants	1 participants
		1 100.0%	1 100.0%		3 100.0%	1 100.0%
Urine Bacteria (/LPF) >20	Number Analyzed	2 participants	1 participants	1 participants	4 participants	0 participants
		0 0.0%	0 0.0%	0 0.0%	0 0.0%

Adverse Events

Time Frame	From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Adverse Event Reporting Description	Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
Arm/Group Title	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
Arm/Group Description	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.	This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.	This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
All-Cause Mortality
	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Serious Adverse Events
	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/23 (0.00%)	1/22 (4.55%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	1/11 (9.09%)	3/45 (6.67%)	0/43 (0.00%)
Ear and labyrinth disorders
Hypoacusis * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
General disorders
Chest pain * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	1/45 (2.22%)	0/43 (0.00%)
Infections and infestations
Viral sepsis * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Investigations
Fibrin D dimer increased * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
SARS-CoV-2 test positive * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	1/45 (2.22%)	0/43 (0.00%)
Nervous system disorders
Presyncope * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Vascular disorders
Hypertension * 1	0/23 (0.00%)	1/22 (4.55%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	1/45 (2.22%)	0/43 (0.00%)
1 Term from vocabulary, MedDRA v23.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo QD->PF-06826647 200 mg QD Group	Placebo QD->PF-06826647 400 mg QD Group	PF-06826647 50 mg QD->PF-06826647 200 mg QD Group	PF-06826647 50 mg QD->PF-06826647 400 mg QD Group	PF-06826647 100 mg QD->PF-06826647 200 mg QD Group	PF-06826647 100 mg QD->PF-06826647 400 mg QD Group	PF-06826647 200 mg QD->PF-06826647 200 mg QD Group	PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	14/23 (60.87%)	11/22 (50.00%)	10/11 (90.91%)	8/11 (72.73%)	9/12 (75.00%)	9/11 (81.82%)	29/45 (64.44%)	32/43 (74.42%)
Blood and lymphatic system disorders
Anaemia * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	2/11 (18.18%)	0/12 (0.00%)	0/11 (0.00%)	1/45 (2.22%)	3/43 (6.98%)
Leukocytosis * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Leukopenia * 1	0/23 (0.00%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	1/45 (2.22%)	0/43 (0.00%)
Lymphadenopathy * 1	2/23 (8.70%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	1/11 (9.09%)	1/45 (2.22%)	2/43 (4.65%)
Lymphocytosis * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Neutropenia * 1	1/23 (4.35%)	0/22 (0.00%)	1/11 (9.09%)	1/11 (9.09%)	0/12 (0.00%)	0/11 (0.00%)	3/45 (6.67%)	2/43 (4.65%)
Cardiac disorders
Atrial fibrillation * 1	1/23 (4.35%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Ear and labyrinth disorders
Tinnitus * 1	0/23 (0.00%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Vertigo * 1	1/23 (4.35%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Vestibular disorder * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Endocrine disorders
Autoimmune thyroiditis * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Eye disorders
Diplopia * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Strabismus * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Gastrointestinal disorders
Abdominal pain * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	0/11 (0.00%)	2/45 (4.44%)	1/43 (2.33%)
Abdominal pain upper * 1	0/23 (0.00%)	2/22 (9.09%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	3/43 (6.98%)
Constipation * 1	1/23 (4.35%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Diarrhoea * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	1/11 (9.09%)	0/45 (0.00%)	1/43 (2.33%)
Dyspepsia * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	1/45 (2.22%)	0/43 (0.00%)
Nausea * 1	1/23 (4.35%)	1/22 (4.55%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	2/45 (4.44%)	1/43 (2.33%)
Toothache * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	0/45 (0.00%)	1/43 (2.33%)
Vomiting * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	2/43 (4.65%)
General disorders
Asthenia * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Fatigue * 1	0/23 (0.00%)	1/22 (4.55%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	2/45 (4.44%)	2/43 (4.65%)
Feeling hot * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Oedema peripheral * 1	0/23 (0.00%)	1/22 (4.55%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Peripheral swelling * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Pyrexia * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Vessel puncture site bruise * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Infections and infestations
Bronchitis * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	0/11 (0.00%)	3/45 (6.67%)	1/43 (2.33%)
Erythema migrans * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Folliculitis * 1	2/23 (8.70%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	1/45 (2.22%)	0/43 (0.00%)
Fungal skin infection * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Gastroenteritis * 1	0/23 (0.00%)	1/22 (4.55%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	1/45 (2.22%)	0/43 (0.00%)
Gastroenteritis viral * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Hordeolum * 1	0/23 (0.00%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Laryngitis * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Nasopharyngitis * 1	6/23 (26.09%)	1/22 (4.55%)	3/11 (27.27%)	1/11 (9.09%)	3/12 (25.00%)	2/11 (18.18%)	6/45 (13.33%)	12/43 (27.91%)
Pharyngitis * 1	0/23 (0.00%)	1/22 (4.55%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	0/45 (0.00%)	1/43 (2.33%)
Pneumonia * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Respiratory tract infection * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Sinusitis * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	1/43 (2.33%)
Upper respiratory tract infection * 1	1/23 (4.35%)	1/22 (4.55%)	2/11 (18.18%)	2/11 (18.18%)	0/12 (0.00%)	1/11 (9.09%)	3/45 (6.67%)	4/43 (9.30%)
Urinary tract infection * 1	1/23 (4.35%)	1/22 (4.55%)	1/11 (9.09%)	1/11 (9.09%)	0/12 (0.00%)	0/11 (0.00%)	1/45 (2.22%)	2/43 (4.65%)
Viral upper respiratory tract infection * 1	1/23 (4.35%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	2/12 (16.67%)	0/11 (0.00%)	1/45 (2.22%)	1/43 (2.33%)
Injury, poisoning and procedural complications
Contusion * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	2/11 (18.18%)	1/45 (2.22%)	3/43 (6.98%)
Diffuse axonal injury * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Hand fracture * 1	0/23 (0.00%)	1/22 (4.55%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Ligament sprain * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Road traffic accident * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Skin laceration * 1	0/23 (0.00%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Investigations
Activated partial thromboplastin time prolonged * 1	1/23 (4.35%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Alanine aminotransferase increased * 1	1/23 (4.35%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	2/45 (4.44%)	3/43 (6.98%)
Aspartate aminotransferase increased * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	2/43 (4.65%)
Blood creatine phosphokinase increased * 1	1/23 (4.35%)	1/22 (4.55%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	5/45 (11.11%)	6/43 (13.95%)
Blood pressure diastolic increased * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Blood pressure increased * 1	1/23 (4.35%)	0/22 (0.00%)	1/11 (9.09%)	1/11 (9.09%)	1/12 (8.33%)	2/11 (18.18%)	4/45 (8.89%)	4/43 (9.30%)
Gamma-glutamyltransferase increased * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	3/43 (6.98%)
Prothrombin time prolonged * 1	1/23 (4.35%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
SARS-CoV-2 test positive * 1	0/23 (0.00%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	2/45 (4.44%)	0/43 (0.00%)
Serum ferritin increased * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Transaminases increased * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	2/23 (8.70%)	1/22 (4.55%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	2/11 (18.18%)	0/45 (0.00%)	2/43 (4.65%)
Back pain * 1	1/23 (4.35%)	0/22 (0.00%)	1/11 (9.09%)	1/11 (9.09%)	1/12 (8.33%)	0/11 (0.00%)	1/45 (2.22%)	3/43 (6.98%)
Joint swelling * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Limb discomfort * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Myalgia * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	1/43 (2.33%)
Pain in extremity * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	1/43 (2.33%)
Psoriatic arthropathy * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	1/12 (8.33%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Nervous system disorders
Circadian rhythm sleep disorder * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Dysgeusia * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	1/45 (2.22%)	0/43 (0.00%)
Headache * 1	2/23 (8.70%)	1/22 (4.55%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	2/45 (4.44%)	6/43 (13.95%)
Peripheral sensory neuropathy * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Sciatica * 1	0/23 (0.00%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	1/43 (2.33%)
Syncope * 1	0/23 (0.00%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Pregnancy, puerperium and perinatal conditions
Pregnancy * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Psychiatric disorders
Depression * 1	0/23 (0.00%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	1/12 (8.33%)	0/11 (0.00%)	1/45 (2.22%)	0/43 (0.00%)
Epistaxis * 1	0/23 (0.00%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Nasal mucosal hypertrophy * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Nasal polyps * 1	0/23 (0.00%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Nasal septum deviation * 1	0/23 (0.00%)	0/22 (0.00%)	1/11 (9.09%)	0/11 (0.00%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Skin and subcutaneous tissue disorders
Pseudofolliculitis * 1	0/23 (0.00%)	0/22 (0.00%)	0/11 (0.00%)	1/11 (9.09%)	0/12 (0.00%)	0/11 (0.00%)	0/45 (0.00%)	0/43 (0.00%)
Psoriasis * 1	1/23 (4.35%)	0/22 (0.00%)	0/11 (0.00%)	0/11 (0.00%)	0/12 (0.00%)	1/11 (9.09%)	0/45 (0.00%)	0/43 (0.00%)
Vascular disorders
Hypertension * 1	1/23 (4.35%)	1/22 (4.55%)	0/11 (0.00%)	1/11 (9.09%)	1/12 (8.33%)	0/11 (0.00%)	2/45 (4.44%)	5/43 (11.63%)
1 Term from vocabulary, MedDRA v23.1; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03895372
• Other Study ID Numbers: C2501004; 2018-004669-16 ( EudraCT Number )
• First Submitted: March 13, 2019
• First Posted: March 29, 2019
• Results First Submitted: May 3, 2021
• Results First Posted: August 27, 2021
• Last Update Posted: August 27, 2021