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Trial record 1 of 1 for:    B7981019
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A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03715829
Recruitment Status : Completed
First Posted : October 23, 2018
Results First Posted : March 25, 2022
Last Update Posted : March 25, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Active Non-segmental Vitiligo
Interventions Drug: PF-06651600
Drug: placebo
Drug: PF06700841
Device: narrow-band UVB phototherapy
Enrollment 366
Recruitment Details  
Pre-assignment Details A total of 578 participants were screened for this study; 366 were randomized to treatment and 364 (99.5%) received treatment in the Dose Ranging Period.
Arm/Group Title PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo Extension (EXT) PF-06700841 60 mg - 30 mg QD EXT PF-06651600 200 Mg-50 mg QD + nbUVB EXT PF-06651600 200 mg - 50 mg QD EXT PF-06651600 50 mg QD EXT PF-06651600 30 mg QD
Hide Arm/Group Description Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks. Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks. Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks. Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks. Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks. Participants were randomized to receive placebo for 24 weeks. After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label. Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label. Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded. Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded. Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Period Title: Dose Ranging Period
Started [1] 65 67 67 50 49 66 0 0 0 0 0
Completed 53 58 54 36 42 55 0 0 0 0 0
Not Completed 12 9 13 14 7 11 0 0 0 0 0
Reason Not Completed
Adverse Event             2             4             5             2             3             3             0             0             0             0             0
Lack of Efficacy             0             1             0             1             0             0             0             0             0             0             0
Lost to Follow-up             2             0             1             1             1             2             0             0             0             0             0
Protocol Violation             0             0             0             1             0             0             0             0             0             0             0
Withdrawal by Subject             8             4             3             9             2             3             0             0             0             0             0
Medication Error Without Associated Adverse Event             0             0             1             0             0             0             0             0             0             0             0
No Longer Meets Eligibility Criteria             0             0             1             0             1             0             0             0             0             0             0
Other             0             0             2             0             0             3             0             0             0             0             0
[1]
The first 6 treatment groups entered this Dose Ranging Period.
Period Title: Extension Period
Started [1] 0 0 0 0 0 0 55 43 187 6 2
Completed 0 0 0 0 0 0 47 27 158 3 2
Not Completed 0 0 0 0 0 0 8 16 29 3 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             3             1             6             0             0
Lack of Efficacy             0             0             0             0             0             0             1             9             2             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             2             0             0
Protocol Violation             0             0             0             0             0             0             0             0             1             0             0
Withdrawal by Subject             0             0             0             0             0             0             3             3             12             3             0
Medication Error Without Associated Adverse Event             0             0             0             0             0             0             0             1             1             0             0
No Longer Meets Eligibility Criteria             0             0             0             0             0             0             0             0             1             0             0
Other             0             0             0             0             0             0             1             2             4             0             0
[1]

The last 5 EXT treatment groups entered this Extension Period.

Three participants were lost to follow-up after completing the Dose Ranging Period, and no extension treatment was recorded for these 3 participants. A total of 295 participants were assigned to the Extension Period, among whom 293 received treatment.
Arm/Group Title PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo Total
Hide Arm/Group Description Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks. Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks. Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks. Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks. Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks. Participants were randomized to receive placebo for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 65 67 67 50 49 66 364
Hide Baseline Analysis Population Description
Baseline analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication).
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 65 participants 67 participants 67 participants 50 participants 49 participants 66 participants 364 participants
<18 Years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
18 - 44 Years
33
  50.8%
29
  43.3%
33
  49.3%
20
  40.0%
16
  32.7%
30
  45.5%
161
  44.2%
45 - 64 Years
30
  46.2%
37
  55.2%
34
  50.7%
30
  60.0%
31
  63.3%
32
  48.5%
194
  53.3%
≥65 Years
2
   3.1%
1
   1.5%
0
   0.0%
0
   0.0%
2
   4.1%
4
   6.1%
9
   2.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 67 participants 67 participants 50 participants 49 participants 66 participants 364 participants
Female
30
  46.2%
31
  46.3%
39
  58.2%
28
  56.0%
25
  51.0%
40
  60.6%
193
  53.0%
Male
35
  53.8%
36
  53.7%
28
  41.8%
22
  44.0%
24
  49.0%
26
  39.4%
171
  47.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 67 participants 67 participants 50 participants 49 participants 66 participants 364 participants
Hispanic or Latino
11
  16.9%
9
  13.4%
11
  16.4%
12
  24.0%
7
  14.3%
7
  10.6%
57
  15.7%
Not Hispanic or Latino
54
  83.1%
58
  86.6%
54
  80.6%
38
  76.0%
41
  83.7%
58
  87.9%
303
  83.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
   3.0%
0
   0.0%
1
   2.0%
1
   1.5%
4
   1.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 67 participants 67 participants 50 participants 49 participants 66 participants 364 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
1
   0.3%
Asian
15
  23.1%
17
  25.4%
17
  25.4%
5
  10.0%
11
  22.4%
21
  31.8%
86
  23.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   4.6%
0
   0.0%
0
   0.0%
4
   8.0%
1
   2.0%
2
   3.0%
10
   2.7%
White
44
  67.7%
47
  70.1%
45
  67.2%
39
  78.0%
33
  67.3%
38
  57.6%
246
  67.6%
More than one race
0
   0.0%
1
   1.5%
1
   1.5%
0
   0.0%
2
   4.1%
1
   1.5%
5
   1.4%
Unknown or Not Reported
3
   4.6%
2
   3.0%
4
   6.0%
1
   2.0%
2
   4.1%
4
   6.1%
16
   4.4%
1.Primary Outcome
Title Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period
Hide Description Central read F-VASI was assessed based on the facial photographs taken at the site. Central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. The higher score of F-VASI signified severer symptoms of non-segmental vitiligo. Percent change from baseline in central read F-VASI = ((post-baseline central read F-VASI - baseline central read F-VASI)/baseline central read F-VASI)×100. A negative percent change from baseline in central read F-VASI signified an improvement.
Time Frame Baseline, Week 24 (Baseline was defined as the last measurement prior to Study Day 18)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 62 63 59 45 48 57
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change
-21.2  (4.13) -21.2  (4.16) -18.5  (4.44) -14.6  (5.47) -3.0  (4.65) 2.1  (4.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06651600 200 mg - 50 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Hochberg's step-up procedure was conducted to compare ritlecitinib 200mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference (Net)
Estimated Value -23.2
Confidence Interval (2-Sided) 90%
-32.53 to -13.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06651600 100 mg - 50 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Hochberg's step-up procedure was conducted to compare ritlecitinib 100mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference (Net)
Estimated Value -23.2
Confidence Interval (2-Sided) 90%
-32.53 to -13.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-06651600 50 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Hochberg's step-up procedure was conducted to compare the ritlecitinib 50 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference (Net)
Estimated Value -20.6
Confidence Interval (2-Sided) 90%
-30.23 to -10.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-06651600 30 mg QD, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0068
Comments Hochberg's step-up procedure was conducted to compare the ritlecitinib 30 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference (Net)
Estimated Value -16.7
Confidence Interval (2-Sided) 90%
-27.77 to -5.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-06651600 10 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2015
Comments Hochberg's step-up procedure was conducted to compare the ritlecitinib 10 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference (Net)
Estimated Value -5.1
Confidence Interval (2-Sided) 90%
-15.02 to 4.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.03
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period
Hide Description Adverse Event (AE) was defined as any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; or that was considered to be an important medical event. Causality to study treatment was determined by the investigator.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of investigational product.
Arm/Group Title PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 65 67 67 50 49 66
Measure Type: Count of Participants
Unit of Measure: Participants
Participants With All-Causality TEAEs
56
  86.2%
45
  67.2%
54
  80.6%
30
  60.0%
40
  81.6%
52
  78.8%
Participants With Treatment-Related TEAEs
32
  49.2%
19
  28.4%
20
  29.9%
17
  34.0%
18
  36.7%
20
  30.3%
Participants With All-Causality SAEs
0
   0.0%
0
   0.0%
1
   1.5%
1
   2.0%
1
   2.0%
1
   1.5%
Participants With Treatment-Related SAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period
Hide Description

An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. The abnormal test findings, clinically significant signs and symptoms of anaemia, neutropenia, thrombocytopenia and lymphopenia were reported as AEs. The clinical significance was determined by the investigator.

An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.

Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of investigational product.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 65 67 67 50 49 66
Measure Type: Count of Participants
Unit of Measure: Participants
Participants With Anaemia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Participants With Neutropenia
0
   0.0%
1
   1.5%
0
   0.0%
0
   0.0%
1
   2.0%
1
   1.5%
Participants With Thrombocytopenia
1
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Participants With Lymphopenia
1
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period
Hide Description

Participants had to abstain from all food and drink (except water and non-investigational products) for an 8-hour overnight fast prior to fasting lipid profile panel collection. Fasting lipid assessment included total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. The clinical meaningfulness was determined by the investigator.

Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of investigational product.
Arm/Group Title PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 65 67 67 50 49 66
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period
Hide Description Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of investigational product.
Arm/Group Title PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 65 67 67 50 49 66
Measure Type: Count of Participants
Unit of Measure: Participants
Bilirubin > 1.5 x upper limit of normal (ULN)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST > 2.5 x ULN
1
   1.5%
0
   0.0%
1
   1.5%
0
   0.0%
1
   2.0%
0
   0.0%
ALT > 2.5 x ULN
0
   0.0%
0
   0.0%
1
   1.5%
1
   2.0%
1
   2.0%
1
   1.5%
6.Primary Outcome
Title Number of Participants With TEAEs and SAEs - Extension (Ext) Period
Hide Description AE was defined as any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. SAE was defined as any untoward medical occurrence at any dose that resulted in death; was life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; or that was considered to be an important medical event. Causality to study treatment was determined by the investigator.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of investigational product.
Arm/Group Title Extension (EXT) PF-06700841 60 mg - 30 mg QD EXT PF-06651600 200 Mg-50 mg QD + nbUVB EXT PF-06651600 200 mg - 50 mg QD EXT PF-06651600 50 mg QD EXT PF-06651600 30 mg QD
Hide Arm/Group Description:
After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.
Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.
Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.
Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Overall Number of Participants Analyzed 55 43 187 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
Participants With All-Causality TEAEs
38
  69.1%
32
  74.4%
119
  63.6%
3
  50.0%
2
 100.0%
Participants With Treatment-Related TEAEs
20
  36.4%
12
  27.9%
36
  19.3%
0
   0.0%
0
   0.0%
Participants With All-Causality SAEs
1
   1.8%
0
   0.0%
1
   0.5%
0
   0.0%
0
   0.0%
Participants With Treatment-Related SAEs
1
   1.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period
Hide Description

An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. The abnormal test findings, clinically significant signs and symptoms of anaemia, neutropenia, thrombocytopenia and lymphopenia were reported as AEs. The clinical significance was determined by the investigator.

An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of investigational product.
Arm/Group Title Extension (EXT) PF-06700841 60 mg - 30 mg QD EXT PF-06651600 200 Mg-50 mg QD + nbUVB EXT PF-06651600 200 mg - 50 mg QD EX PF-06651600 50mg QD EXT PF-06651600 30 mg QD
Hide Arm/Group Description:
After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.
Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.
50 mg QD of PF 06651600 for 24 weeks. This arm is double blinded.
Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Overall Number of Participants Analyzed 55 43 187 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
Participants With Anemia
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
Participants With Neutropenia
1
   1.8%
0
   0.0%
1
   0.5%
0
   0.0%
0
   0.0%
Participants With Thrombocytopenia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Participants With Lymphopenia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Primary Outcome
Title Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile - Ext Period
Hide Description Participants had to abstain from all food and drink (except water and non-investigational products) for an 8-hour overnight fast prior to fasting lipid profile panel collection. Fasting lipid assessment included total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. The clinical meaningfulness was determined by the investigator.
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of investigational product.
Arm/Group Title Extension (EXT) PF-06700841 60 mg - 30 mg QD EXT PF-06651600 200 Mg-50 mg QD + nbUVB EXT PF-06651600 200 mg - 50 mg QD EXT PF-06651600 50 mg QD EXT PF-06651600 30 mg QD
Hide Arm/Group Description:
After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.
Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.
Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.
Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Overall Number of Participants Analyzed 55 43 187 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9.Primary Outcome
Title Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period
Hide Description Liver function tests included tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population included all participants who received at least 1 dose of investigational product. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Extension (EXT) PF-06700841 60 mg - 30 mg QD EXT PF-06651600 200 Mg-50 mg QD + nbUVB EXT PF-06651600 200 mg - 50 mg QD EXT PF-06651600 50 mg QD EXT PF-06651600 30 mg QD
Hide Arm/Group Description:
After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label.
Induction dose of ritlecitinib 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by ritlecitinib 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provided nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm was open label.
Induction dose of ritlecitinib 200 mg QD of for 4 weeks followed by ritlecitinib 50 mg QD for 20 weeks. This arm was double blinded.
Ritlecitinib 50 mg QD for 24 weeks. This arm was double blinded.
Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
Overall Number of Participants Analyzed 55 42 186 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
Bilirubin > 1.5 x ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST > 2.5 x ULN
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT > 2.5 x ULN
0
   0.0%
0
   0.0%
1
   0.5%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Percentage of Participants Achieving Central F-VASI75 at Week 24 - DR Period
Hide Description

This outcome measure was the percentage of participants achieving at least 75% improvement from baseline in central read F-VASI (F-VASI75) at Week 24. A negative percent change from baseline in central read F-VASI signified an improvement. The central read F-VASI75 response rate was analyzed by first treating the missing data (non-COVID-19 related) as non responders and then applying Chan and Zhang exact confidence interval (CI) method at Week 24.

Central read F-VASI75=1 if percent change from baseline ≥75; central read F-VASI75=0 if percent change from baseline <75. Percent change from baseline in F-VASI=((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. Baseline was defined as the last measurement prior to study Day 18.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 58 59 52 37 43 57
Measure Type: Number
Unit of Measure: Percentage of Participants
12.1 8.5 7.7 2.7 2.3 0
11.Secondary Outcome
Title Percentage of Participants Achieving T-VASI50 at Week 24 - DR Period
Hide Description Total body VASI (T-VASI) was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: T-VASI= Ʃ[Hand Units]×[Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities (excluding hands), trunk, lower extremities (excluding feet), and feet. The extent of depigmentation was expressed by percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. The data below was the percentage of participants achieving at least 50% improvement from baseline in T-VASI (T-VASI50) at Week 24. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 63 65 65 47 49 66
Measure Type: Number
Unit of Measure: Percentage of Participants
7.9 4.6 4.6 10.6 4.1 9.1
12.Secondary Outcome
Title Percent Change From Baseline in T-VASI at Designated Time Points - DR Period
Hide Description The T-VASI was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities (excluding hands), trunk, lower extremities (excluding the feet), and feet. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in T-VASI=((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change
Week 4 Number Analyzed 64 participants 66 participants 64 participants 50 participants 47 participants 63 participants
-2.4  (1.51) -3.0  (1.50) -2.6  (1.50) -5.1  (1.72) -2.9  (1.76) -1.4  (1.52)
Week 8 Number Analyzed 63 participants 65 participants 63 participants 48 participants 48 participants 64 participants
-6.2  (2.03) -5.4  (2.01) -5.1  (2.01) -6.6  (2.33) -3.0  (2.32) -5.8  (2.02)
Week 12 Number Analyzed 59 participants 62 participants 60 participants 44 participants 46 participants 61 participants
-7.2  (2.44) -11.9  (2.40) -9.1  (2.40) -11.4  (2.82) -4.9  (2.76) -8.0  (2.40)
Week 16 Number Analyzed 56 participants 57 participants 55 participants 43 participants 43 participants 58 participants
-10.0  (2.66) -13.1  (2.67) -12.6  (2.66) -11.9  (3.03) -5.7  (3.03) -12.0  (2.62)
Week 20 Number Analyzed 52 participants 59 participants 53 participants 43 participants 41 participants 55 participants
-13.8  (3.13) -16.0  (2.98) -14.2  (3.07) -12.0  (3.43) -9.2  (3.51) -13.3  (3.04)
Week 24 Number Analyzed 52 participants 58 participants 52 participants 36 participants 41 participants 56 participants
-14.7  (3.49) -19.2  (3.29) -14.7  (3.44) -14.0  (4.15) -12.1  (3.88) -11.0  (3.34)
13.Secondary Outcome
Title Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period
Hide Description

The central read F-VASI was assessed based on the facial photographs taken at the site. The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area.

Percent change from baseline in central read F-VASI = ((post-baseline central read F-VASI - baseline central read F-VASI)/baseline central read F-VASI)×100. Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
Time Frame Baseline, Weeks 4, 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 62 63 59 45 48 57
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change
Week 4 Number Analyzed 61 participants 60 participants 55 participants 44 participants 47 participants 56 participants
0.1  (0.80) 0.4  (0.82) -0.2  (0.84) -1.2  (0.94) 0.0  (0.91) 0.6  (0.83)
Week 8 Number Analyzed 57 participants 57 participants 52 participants 43 participants 47 participants 55 participants
-7.0  (1.42) -5.3  (1.44) -1.8  (1.46) -1.4  (1.62) -0.1  (1.55) -0.2  (1.44)
Week 16 Number Analyzed 51 participants 49 participants 49 participants 34 participants 37 participants 47 participants
-17.0  (3.16) -16.4  (3.25) -10.7  (3.19) -13.3  (3.87) -5.6  (3.67) -0.2  (3.27)
Week 24 Number Analyzed 49 participants 49 participants 41 participants 27 participants 37 participants 50 participants
-21.2  (4.13) -21.2  (4.16) -18.5  (4.44) -14.6  (5.47) -3.0  (4.65) 2.1  (4.06)
14.Secondary Outcome
Title Percent Change From Baseline in Local F-VASI at Designated Time Points - DR Period
Hide Description

The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0.00 4.00): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%.

Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change
Week 4 Number Analyzed 64 participants 66 participants 64 participants 50 participants 47 participants 63 participants
-4.9  (2.63) 3.1  (2.61) -5.0  (2.60) 0.4  (2.96) -5.3  (3.05) -6.3  (2.63)
Week 8 Number Analyzed 63 participants 65 participants 63 participants 48 participants 48 participants 64 participants
-11.3  (5.35) 0.4  (5.32) -8.8  (5.30) 10.1  (6.09) -7.3  (6.12) -7.5  (5.31)
Week 12 Number Analyzed 59 participants 62 participants 60 participants 44 participants 46 participants 61 participants
-15.9  (4.16) -6.5  (4.11) -12.2  (4.10) -7.1  (4.77) -9.8  (4.72) -11.4  (4.08)
Week 16 Number Analyzed 56 participants 57 participants 56 participants 43 participants 44 participants 58 participants
-19.4  (4.85) -6.2  (4.88) -19.7  (4.82) -6.4  (5.48) -10.3  (5.46) -13.3  (4.75)
Week 20 Number Analyzed 52 participants 59 participants 53 participants 43 participants 41 participants 55 participants
-21.9  (5.59) -12.9  (5.35) -23.2  (5.52) 0.0  (6.11) -14.4  (6.30) -15.3  (5.44)
Week 24 Number Analyzed 52 participants 58 participants 52 participants 36 participants 41 participants 56 participants
-28.3  (5.70) -20.6  (5.38) -26.2  (5.61) -4.3  (6.70) -13.9  (6.32) -18.1  (5.43)
15.Secondary Outcome
Title Percent Change From Baseline in SA-VES at Designated Time Points - DR Period
Hide Description The Self-Assessment Vitiligo Extent Score (SA-VES) was a validated patient report outcome measurement instrument to provide information about disease extent. Vitiligo Extent Score (VES) was a measure to express the overall vitiligo involvement of the body (extent). Clinical illustrations for 19 separate body areas that reflected different degrees of involvement (1%, 5%, 10%, 25%, 50% and 75% depigmentation) were chosen to represent the participant's skin lesions to get the total extent of the disease. VES was a sum of all surface measurement that was similar to VASI. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change
Week 4 Number Analyzed 62 participants 66 participants 64 participants 50 participants 47 participants 63 participants
2.7  (17.19) 1.1  (16.71) -1.1  (16.74) 4.9  (19.25) 4.9  (19.84) 50.4  (17.13)
Week 16 Number Analyzed 54 participants 55 participants 56 participants 41 participants 44 participants 58 participants
4.7  (13.82) -0.5  (13.48) -3.7  (13.45) 6.9  (15.53) -0.5  (15.87) 52.5  (13.72)
Week 24 Number Analyzed 50 participants 56 participants 49 participants 32 participants 40 participants 55 participants
0.0  (10.35) -3.5  (10.02) -4.3  (10.11) -4.4  (11.89) -1.6  (11.77) 44.0  (10.16)
16.Secondary Outcome
Title Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period
Hide Description

The T-VASI was calculated using a formula that included contribution from 6 different body regions (possible range, 0-100) with a modified method: VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 separate and mutually exclusive regions: face/neck, hands, upper extremities (excluding hands), trunk, lower extremities (excluding the feet), and feet. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%.

The absolute change from baseline in T-VASI was analyzed using the ANCOVA analysis. Negative change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and have a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
Week 4 Number Analyzed 64 participants 66 participants 64 participants 50 participants 47 participants 63 participants
-0.3  (0.25) -0.5  (0.25) -0.6  (0.25) -1.0  (0.28) -0.4  (0.29) -0.2  (0.25)
Week 8 Number Analyzed 63 participants 65 participants 63 participants 48 participants 48 participants 64 participants
-0.9  (0.32) -0.9  (0.32) -0.9  (0.32) -1.2  (0.37) -0.5  (0.36) -0.9  (0.32)
Week 12 Number Analyzed 59 participants 62 participants 60 participants 44 participants 46 participants 61 participants
-1.1  (0.41) -2.0  (0.40) -1.6  (0.40) -1.8  (0.47) -0.9  (0.46) -1.6  (0.40)
Week 16 Number Analyzed 56 participants 57 participants 55 participants 43 participants 43 participants 58 participants
-1.5  (0.46) -2.1  (0.46) -1.9  (0.46) -1.9  (0.53) -0.9  (0.53) -2.2  (0.46)
Week 20 Number Analyzed 52 participants 59 participants 53 participants 43 participants 41 participants 55 participants
-2.0  (0.55) -2.8  (0.53) -2.3  (0.54) -2.0  (0.61) -1.7  (0.62) -2.2  (0.54)
Week 24 Number Analyzed 52 participants 58 participants 52 participants 36 participants 41 participants 56 participants
-2.3  (0.62) -3.4  (0.59) -2.4  (0.61) -2.7  (0.74) -2.0  (0.69) -1.8  (0.60)
17.Secondary Outcome
Title Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period
Hide Description T-VASI was calculated by a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. The outcome measure was the percentage of participants achieving at least 50% improvement from baseline in T-VASI (T-VASI50). Percent change from baseline in T-VASI=((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
1.6 1.5 0 2.0 0 0
Week 8 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
1.6 1.5 1.5 4.0 0 1.5
Week 12 Number Analyzed 62 participants 66 participants 66 participants 49 participants 48 participants 66 participants
1.6 1.5 1.5 4.1 0 4.5
Week 16 Number Analyzed 63 participants 62 participants 66 participants 47 participants 46 participants 63 participants
0 3.2 0 2.1 0 6.3
Week 20 Number Analyzed 61 participants 67 participants 64 participants 49 participants 48 participants 63 participants
4.9 1.5 1.6 6.1 2.1 9.5
Week 24 Number Analyzed 63 participants 65 participants 65 participants 47 participants 49 participants 66 participants
7.9 4.6 4.6 10.6 4.1 9.1
18.Secondary Outcome
Title Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period
Hide Description T-VASI was calculated by a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. The outcome measure was the percentage of participants achieving at least 75% improvement from baseline in T-VASI (T-VASI75). Percent change from baseline in T-VASI=((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
0 0 0 0 0 0
Week 8 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
0 0 0 0 0 0
Week 12 Number Analyzed 62 participants 66 participants 66 participants 49 participants 48 participants 66 participants
0 0 0 0 0 0
Week 16 Number Analyzed 63 participants 62 participants 66 participants 47 participants 46 participants 63 participants
0 0 0 0 0 0
Week 20 Number Analyzed 61 participants 67 participants 64 participants 49 participants 48 participants 63 participants
0 0 0 0 0 0
Week 24 Number Analyzed 63 participants 65 participants 65 participants 47 participants 49 participants 66 participants
0 0 0 0 0 0
19.Secondary Outcome
Title Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period
Hide Description T-VASI was calculated by a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. The outcome measure was the percentage of participants achieving at least 90% improvement from baseline in T-VASI (T-VASI90). Percent change from baseline in T-VASI=((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
0 0 0 0 0 0
Week 8 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
0 0 0 0 0 0
Week 12 Number Analyzed 62 participants 66 participants 66 participants 49 participants 48 participants 66 participants
0 0 0 0 0 0
Week 16 Number Analyzed 63 participants 62 participants 66 participants 47 participants 46 participants 63 participants
0 0 0 0 0 0
Week 20 Number Analyzed 61 participants 67 participants 64 participants 49 participants 48 participants 63 participants
0 0 0 0 0 0
Week 24 Number Analyzed 63 participants 65 participants 65 participants 47 participants 49 participants 66 participants
0 0 0 0 0 0
20.Secondary Outcome
Title Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period
Hide Description T-VASI was calculated using a formula that included contribution from 6 body regions (possible range, 0-100): T-VASI = Ʃ [Hand Units] × [Depigmentation]. One hand unit, which encompassed the palm plus the volar surface of all the digits, was approximately 1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of each body region. The body was divided into 6 mutually exclusive regions: face/neck, hands, upper extremities, trunk, lower extremities, and feet. The extent of depigmentation was expressed by the percentages: 0, 10%, 25%, 50%, 75%, 90% or 100%. This outcome measure was the percentage of participants achieving 100% improvement from baseline in T-VASI (T-VASI100). Percent change from baseline in T-VASI = ((post-baseline T-VASI - baseline T-VASI)/baseline T-VASI)×100. Negative percent change from baseline in T-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
0 0 0 0 0 0
Week 8 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
0 0 0 0 0 0
Week 12 Number Analyzed 62 participants 66 participants 66 participants 49 participants 48 participants 66 participants
0 0 0 0 0 0
Week 16 Number Analyzed 63 participants 62 participants 66 participants 47 participants 46 participants 63 participants
0 0 0 0 0 0
Week 20 Number Analyzed 61 participants 67 participants 64 participants 49 participants 48 participants 63 participants
0 0 0 0 0 0
Week 24 Number Analyzed 63 participants 65 participants 65 participants 47 participants 49 participants 66 participants
0 0 0 0 0 0
21.Secondary Outcome
Title Percentage of Participants Achieving Central Read F-VASI50 at Designated Time Points - DR Period
Hide Description The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. This outcome measure was the percentage of participants achieving at least 50% improvement in central read F-VASI from baseline (F-VASI50). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
Time Frame Baseline, Weeks 4, 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 62 63 59 45 48 57
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Number Analyzed 62 participants 63 participants 59 participants 45 participants 48 participants 57 participants
0 0 0 2.2 0 0
Week 8 Number Analyzed 62 participants 63 participants 59 participants 45 participants 48 participants 57 participants
3.2 0 0 2.2 0 0
Week 16 Number Analyzed 61 participants 58 participants 58 participants 39 participants 42 participants 52 participants
14.8 13.8 6.9 10.3 2.4 1.9
Week 24 Number Analyzed 58 participants 59 participants 52 participants 37 participants 43 participants 57 participants
22.4 25.4 15.4 18.9 7.0 1.8
22.Secondary Outcome
Title Percentage of Participants Achieving Central Read F-VASI75 at Designated Time Points - DR Period
Hide Description The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. This outcome measure was the percentage of participants achieving at least 75% improvement in central read F-VASI from baseline (F-VASI75). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
Time Frame Baseline, Weeks 4, 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 62 63 59 45 48 57
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Number Analyzed 62 participants 63 participants 59 participants 45 participants 48 participants 57 participants
0 0 0 0 0 0
Week 8 Number Analyzed 62 participants 63 participants 59 participants 45 participants 48 participants 57 participants
0 0 0 0 0 0
Week 16 Number Analyzed 61 participants 58 participants 58 participants 39 participants 42 participants 52 participants
1.6 1.7 5.2 2.6 2.4 0
Week 24 Number Analyzed 58 participants 59 participants 52 participants 37 participants 43 participants 57 participants
12.1 8.5 7.7 2.7 2.3 0
23.Secondary Outcome
Title Percentage of Participants Achieving Central Read F-VASI90 at Designated Time Points - DR Period
Hide Description The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. This outcome measure was the percentage of participants achieving at least 90% improvement in central read F-VASI from baseline (F-VASI90). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
Time Frame Baseline, Weeks 4, 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 62 63 59 45 48 57
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Number Analyzed 62 participants 63 participants 59 participants 45 participants 48 participants 57 participants
0 0 0 0 0 0
Week 8 Number Analyzed 62 participants 63 participants 59 participants 45 participants 48 participants 57 participants
0 0 0 0 0 0
Week 16 Number Analyzed 61 participants 58 participants 58 participants 39 participants 42 participants 52 participants
0 0 1.7 0 0 0
Week 24 Number Analyzed 58 participants 59 participants 52 participants 37 participants 43 participants 57 participants
1.7 0 3.8 0 0 0
24.Secondary Outcome
Title Percentage of Participants Achieving Central Read F-VASI100 at Designated Time Points - DR Period
Hide Description The central read F-VASI was calculated using a formula that included contribution of affected facial surface areas showing all 6 different depigmentation rates (0.1, 0.25, 0.5, 0.75, 0.9 and 1) with a modified method: F-VASI (central read)=Ʃ [Affected Facial Surface Area] × 4 × [Depigmentation Rates]. Face was defined as the area from the hairline on top of the forehead to the jawline at the bottom of the cheeks. F-VASI (central read) ranged from 0.000 to 4.000 by defining the affected Facial Surface Area (expressed as the value between 0.0 to 1.0) being 4% of total Body Surface Area. Percent change from baseline in F-VASI = ((post-baseline F-VASI - baseline F-VASI)/baseline F-VASI)×100. This outcome measure was the percentage of participants achieving at least 100% improvement in central read F-VASI from baseline (F-VASI100). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to Study Day 18.
Time Frame Baseline, Weeks 4, 8, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 62 63 59 45 48 57
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Number Analyzed 62 participants 63 participants 59 participants 45 participants 48 participants 57 participants
0 0 0 0 0 0
Week 8 Number Analyzed 62 participants 63 participants 59 participants 45 participants 48 participants 57 participants
0 0 0 0 0 0
Week 16 Number Analyzed 61 participants 58 participants 58 participants 39 participants 42 participants 52 participants
0 0 0 0 0 0
Week 24 Number Analyzed 58 participants 59 participants 52 participants 37 participants 43 participants 57 participants
0 0 0 0 0 0
25.Secondary Outcome
Title Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period
Hide Description The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. This outcome measure was the percentage of participants achieving at least 50% improvement in site assessment F-VASI from baseline (F-VASI50). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
3.1 3.0 1.5 2.0 0 3.0
Week 8 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
9.4 3.0 4.5 2.0 4.1 4.5
Week 12 Number Analyzed 62 participants 66 participants 66 participants 49 participants 48 participants 66 participants
16.1 9.1 9.1 8.2 8.3 9.1
Week 16 Number Analyzed 63 participants 62 participants 66 participants 47 participants 47 participants 63 participants
14.3 9.7 13.6 8.5 10.6 14.3
Week 20 Number Analyzed 61 participants 67 participants 64 participants 49 participants 48 participants 63 participants
18.0 14.9 17.2 12.2 16.7 17.5
Week 24 Number Analyzed 63 participants 65 participants 65 participants 47 participants 49 participants 66 participants
20.6 21.5 15.4 10.6 18.4 16.7
26.Secondary Outcome
Title Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period
Hide Description The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. This outcome measure was the percentage of participants achieving at least 75% improvement in site assessment F-VASI from baseline (F-VASI75). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
0 0 0 0 0 1.5
Week 8 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
0 0 3.0 2.0 0 0
Week 12 Number Analyzed 62 participants 66 participants 66 participants 49 participants 48 participants 66 participants
1.6 3.0 4.5 6.1 2.1 1.5
Week 16 Number Analyzed 63 participants 62 participants 66 participants 47 participants 47 participants 63 participants
3.2 0 4.5 4.3 4.3 7.9
Week 20 Number Analyzed 61 participants 67 participants 64 participants 49 participants 48 participants 63 participants
6.6 1.5 9.4 6.1 6.3 11.1
Week 24 Number Analyzed 63 participants 65 participants 65 participants 47 participants 49 participants 66 participants
11.1 4.6 6.2 4.3 4.1 13.6
27.Secondary Outcome
Title Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period
Hide Description The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. This outcome measure was the percentage of participants achieving at least 90% improvement in site assessment F-VASI from baseline (F-VASI90). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
0 0 0 0 0 0
Week 8 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
0 0 1.5 2.0 0 0
Week 12 Number Analyzed 62 participants 66 participants 66 participants 49 participants 48 participants 66 participants
0 0 1.5 2.0 0 0
Week 16 Number Analyzed 63 participants 62 participants 66 participants 47 participants 47 participants 63 participants
1.6 0 3.0 2.1 2.1 0
Week 20 Number Analyzed 61 participants 67 participants 64 participants 49 participants 48 participants 63 participants
1.6 1.5 4.7 2.0 2.1 1.6
Week 24 Number Analyzed 63 participants 65 participants 65 participants 47 participants 49 participants 66 participants
1.6 1.5 3.1 0 4.1 1.5
28.Secondary Outcome
Title Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period
Hide Description The site assessment of the F-VASI was calculated using a formula that included contribution from face (possible range, 0-4): Local F-VASI = [Digit Units] × [Depigmentation] × 0.1. Scalp, neck, eyebrows, eyelashes, and vermilion were excluded from this calculation. The volar surface of 1 digit (the participant's thumb) was approximately 0.1% of the total body surface area and was used as a guide to estimate the baseline percentage of vitiligo involvement of face. The extent of depigmentation was expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. Percent change from baseline in Local F-VASI = ((post baseline Local F-VASI - baseline Local F-VASI)/baseline Local F-VASI)×100. This outcome measure was the percentage of participants achieving 100% improvement in site assessment F-VASI from baseline (F-VASI100). Negative percent change from baseline in F-VASI signified an improvement. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
0 0 0 0 0 0
Week 8 Number Analyzed 64 participants 67 participants 67 participants 50 participants 49 participants 66 participants
0 0 0 2.0 0 0
Week 12 Number Analyzed 62 participants 66 participants 66 participants 49 participants 48 participants 66 participants
0 0 0 0 0 0
Week 16 Number Analyzed 63 participants 62 participants 66 participants 47 participants 47 participants 63 participants
0 0 0 0 0 0
Week 20 Number Analyzed 61 participants 67 participants 64 participants 49 participants 48 participants 63 participants
0 0 1.6 0 0 0
Week 24 Number Analyzed 63 participants 65 participants 65 participants 47 participants 49 participants 66 participants
0 0 1.5 0 0 0
29.Secondary Outcome
Title Change From Baseline in Total VitiQoL Score at Designated Time Points - DR Period
Hide Description

The Vitiligo-Specific Quality of Life (VitiQoL) instrument was a reliable and validated vitiligo disease-specific health-related quality of life (HRQoL) instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from "not at all" (scored 0) to "most of the time" (scored 6) and gave a minimum and maximum score from 0 to 90, with higher scores representing greater burden. The VitiQoL total score was calculated as sum of items 1-15.

The change from baseline in total VitiQoL score was analyzed using the mixed-effect models repeated measures (MMRM) analysis. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
Week 4 Number Analyzed 62 participants 66 participants 64 participants 50 participants 47 participants 63 participants
-3.9  (1.34) -2.9  (1.31) -4.4  (1.31) -4.4  (1.50) -3.5  (1.54) -5.1  (1.33)
Week 16 Number Analyzed 54 participants 56 participants 56 participants 41 participants 44 participants 59 participants
-6.5  (1.83) -4.9  (1.79) -6.3  (1.82) -4.8  (2.07) -10.5  (2.06) -7.1  (1.78)
Week 24 Number Analyzed 50 participants 56 participants 50 participants 34 participants 41 participants 56 participants
-6.5  (1.99) -3.6  (1.92) -7.7  (1.99) -7.0  (2.30) -9.7  (2.22) -6.4  (1.92)
30.Secondary Outcome
Title Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period
Hide Description

The VitiQoL was a reliable and validated vitiligo disease specific HRQoL instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from "not at all" (scored 0) to "most of the time" (scored 6) and gave a minimum and maximum score from 0 to 90, with higher scores representing greater burden. The VitiQoL Participation Limitation domain score was the sum of items 3, 4, 6, 9, 10, 11, 14 and ranged from 0 to 42.

The change from baseline in VitiQoL Participation Limitation Domain Score was analyzed using the MMRM analysis. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
Week 4 Number Analyzed 62 participants 66 participants 64 participants 50 participants 47 participants 63 participants
-1.2  (0.71) -1.1  (0.69) -1.7  (0.69) -1.8  (0.79) -1.0  (0.81) -2.5  (0.70)
Week 16 Number Analyzed 54 participants 56 participants 56 participants 41 participants 44 participants 59 participants
-2.1  (0.88) -1.9  (0.86) -2.6  (0.87) -2.3  (1.00) -4.1  (0.99) -3.1  (0.85)
Week 24 Number Analyzed 50 participants 56 participants 50 participants 34 participants 41 participants 56 participants
-1.4  (0.98) -1.7  (0.94) -3.2  (0.97) -2.8  (1.14) -3.9  (1.09) -2.2  (0.94)
31.Secondary Outcome
Title Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period
Hide Description

The VitiQoL was a reliable and validated vitiligo disease specific HRQoL instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from "not at all" (scored 0) to "most of the time" (scored 6) and gave a minimum and maximum score from 0 to 90, with higher scores representing greater burden. The VitiQoL Stigma domain score was the sum of items 1, 2, 5, 7 and 15, and ranged from 0 to 30.

The change from baseline in VitiQoL Stigma Domain Score was analyzed using the MMRM analysis. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
Week 4 Number Analyzed 62 participants 66 participants 64 participants 50 participants 47 participants 63 participants
-1.9  (0.56) -1.6  (0.55) -2.4  (0.55) -1.7  (0.62) -1.7  (0.64) -1.8  (0.56)
Week 16 Number Analyzed 54 participants 56 participants 56 participants 41 participants 44 participants 59 participants
-3.4  (0.71) -2.3  (0.70) -3.2  (0.71) -1.7  (0.80) -4.3  (0.80) -2.9  (0.69)
Week 24 Number Analyzed 50 participants 56 participants 50 participants 34 participants 41 participants 56 participants
-3.8  (0.76) -2.1  (0.73) -3.7  (0.76) -3.1  (0.88) -4.5  (0.84) -3.2  (0.73)
32.Secondary Outcome
Title Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period
Hide Description

The VitiQoL was a reliable and validated vitiligo disease specific HRQoL instrument which measured concepts relevant to vitiligo participants. The VitiQoL was a 15-item PRO measure which measured concepts of symptoms, daily activities, leisure activities, work, personal relationships and treatment. Responses ranged from "not at all" (scored 0) to "most of the time" (scored 6) and gave a minimum and maximum score from 0 to 90, with higher scores representing greater burden. The VitiQoL Behaviors domain score was the sum of items 8, 12 and 13, and ranged from 0 to 18.

The change from baseline in VitiQoL Behaviors Domain Score was analyzed using the MMRM analysis. Baseline was defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Weeks 4, 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 64 67 67 50 49 66
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
Week 4 Number Analyzed 62 participants 66 participants 64 participants 50 participants 47 participants 63 participants
-0.8  (0.37) -0.3  (0.36) -0.2  (0.36) -0.9  (0.41) -0.7  (0.42) -0.7  (0.37)
Week 16 Number Analyzed 54 participants 56 participants 56 participants 41 participants 44 participants 59 participants
-1.1  (0.50) -0.8  (0.49) -0.5  (0.50) -0.9  (0.57) -2.1  (0.56) -1.0  (0.49)
Week 24 Number Analyzed 50 participants 56 participants 50 participants 34 participants 41 participants 56 participants
-1.4  (0.53) 0  (0.52) -0.7  (0.53) -1.3  (0.62) -1.3  (0.60) -0.9  (0.51)
33.Secondary Outcome
Title Percentage of Participants Achieving sIGA 0 or 1 and at Least a 2-Point Improvement at Week 24 - DR Period
Hide Description

The percentage of participants achieving a static Investigator Global Assessment (sIGA) Score 0/1 and sIGA ≥2-point improvement at Week 24 was presented in this outcome measure. The sIGA score ranged from 0 to 4.

The sIGA Score 0 represented "Clear" with no signs of loss of pigmentation with natural light or with Woods lamp examination.

The sIGA Score 1 represented "Almost Clear" with the following descriptors:

  • Faint, barely detectable loss of pigmentation mainly located on dorsal hands, feet, bony prominences, and/or limited areas.
  • Approximately 90% pigmentation within lesions.
  • No or rare signs of Koebner phenomenon, confetti like or trichrome lesions could be present.

The sIGA Scores 2, 3 and 4 represented "Mild Vitiligo", "Moderate Vitiligo" and "Severe Vitiligo", respectively.
Time Frame Week 24
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Hide Analysis Population Description
The analysis population included all participants who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline measurement (after taking randomization study medication). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title PF-06651600 200mg - 50mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo
Hide Arm/Group Description:
Participants were randomized to receive ritlecitinib induction dose (200 mg QD) for 4 weeks followed by maintenance dosing of 50 mg QD for 20 weeks
Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks.
Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks.
Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks.
Participants were randomized to receive placebo for 24 weeks.
Overall Number of Participants Analyzed 62 64 65 46 48 65
Measure Type: Number
Unit of Measure: Percentage of Participants
0 0 0 0 0 0
Time Frame 48 weeks
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo Extension (EXT) PF-06700841 60 mg - 30 mg QD EX PF-06651600 200 mg - 50 mg QD + nbUVB EX PF-06651600 200mg-50mg QD EX PF-06651600 50mg QD EXT PF-06651600 30 mg QD
Hide Arm/Group Description Participants were randomized to receive ritlecitinib (PF-06651600) induction dose of 200 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks. Participants were randomized to receive ritlecitinib induction dose of 100 mg QD for 4 weeks followed by ritlecitinib 50 mg QD for another 20 weeks. Participants were randomized to receive ritlecitinib 50 mg QD for 24 weeks. Participants were randomized to receive ritlecitinib 30 mg QD for 24 weeks. Participants were randomized to receive ritlecitinib 10 mg QD for 24 weeks. Participants were randomized to receive placebo for 24 weeks. After a 4-week drug holiday, participants received induction dose of brepocitinib (PF-06700841) 60 mg QD for 4 weeks followed by brepocitinib 30 mg QD for 16 weeks. This arm was open label. Induction dose of PF-06651600 200 mg QD plus standardized narrow band UVB (nbUVB) add-on therapy for 4 weeks followed by maintenance dosing of PF-06651600 50 mg QD plus standardized nbUVB add-on therapy for 20 weeks (only for participants who provide nbUVB consent). Participants who had <10% improvement in percent change in VASI at Extension Week 12 from the baseline value at Dose Ranging Period Week 24 were discontinued from the treatment and entered Follow-up Period. This arm is open label. Induction dose of 200 mg QD of PF 06651600 for 4 weeks followed by maintenance dosing of 50 mg QD of PF 06651600 for 20 weeks. This arm is double blinded. 50 mg QD of PF 06651600 for 24 weeks. This arm is double blinded. Ritlecitinib 30 mg QD of for 24 weeks. This arm was double blinded.
All-Cause Mortality
PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo Extension (EXT) PF-06700841 60 mg - 30 mg QD EX PF-06651600 200 mg - 50 mg QD + nbUVB EX PF-06651600 200mg-50mg QD EX PF-06651600 50mg QD EXT PF-06651600 30 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) 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   0/65 (0.00%)      0/67 (0.00%)      0/67 (0.00%)      0/50 (0.00%)      0/49 (0.00%)      0/66 (0.00%)      0/55 (0.00%)      0/43 (0.00%)      0/187 (0.00%)      0/6 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo Extension (EXT) PF-06700841 60 mg - 30 mg QD EX PF-06651600 200 mg - 50 mg QD + nbUVB EX PF-06651600 200mg-50mg QD EX PF-06651600 50mg QD EXT PF-06651600 30 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/65 (0.00%)      0/67 (0.00%)      1/67 (1.49%)      1/50 (2.00%)      1/49 (2.04%)      1/66 (1.52%)      1/55 (1.82%)      0/43 (0.00%)      1/187 (0.53%)      0/6 (0.00%)      0/2 (0.00%)    
Gastrointestinal disorders                       
Oesophageal spasm * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 1/50 (2.00%)  1 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations                       
Disseminated varicella zoster virus infection * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 1/55 (1.82%)  1 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
Uterine leiomyoma * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 1/187 (0.53%)  1 0/6 (0.00%)  0 0/2 (0.00%)  0
Nervous system disorders                       
Migraine * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 1/67 (1.49%)  1 0/50 (0.00%)  0 1/49 (2.04%)  1 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Renal and urinary disorders                       
Neurogenic bladder * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 1/66 (1.52%)  1 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
1
Term from vocabulary, MedDRA 24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PF-06651600 200 mg - 50 mg QD PF-06651600 100 mg - 50 mg QD PF-06651600 50 mg QD PF-06651600 30 mg QD PF-06651600 10 mg QD Placebo Extension (EXT) PF-06700841 60 mg - 30 mg QD EX PF-06651600 200 mg - 50 mg QD + nbUVB EX PF-06651600 200mg-50mg QD EX PF-06651600 50mg QD EXT PF-06651600 30 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/65 (47.69%)      35/67 (52.24%)      32/67 (47.76%)      23/50 (46.00%)      22/49 (44.90%)      37/66 (56.06%)      17/55 (30.91%)      14/43 (32.56%)      46/187 (24.60%)      3/6 (50.00%)      2/2 (100.00%)    
Blood and lymphatic system disorders                       
Anaemia * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
Ear and labyrinth disorders                       
Ear pain * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
Gastrointestinal disorders                       
Abdominal pain * 1  0/65 (0.00%)  0 1/67 (1.49%)  1 2/67 (2.99%)  3 0/50 (0.00%)  0 1/49 (2.04%)  1 4/66 (6.06%)  4 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Diarrhoea * 1  0/65 (0.00%)  0 5/67 (7.46%)  7 2/67 (2.99%)  2 4/50 (8.00%)  5 1/49 (2.04%)  1 1/66 (1.52%)  2 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Dyspepsia * 1  1/65 (1.54%)  1 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 3/49 (6.12%)  4 3/66 (4.55%)  3 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
General disorders                       
Fatigue * 1  6/65 (9.23%)  6 1/67 (1.49%)  1 2/67 (2.99%)  2 0/50 (0.00%)  0 1/49 (2.04%)  1 1/66 (1.52%)  1 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Influenza like illness * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
Infections and infestations                       
Bronchitis * 1  0/65 (0.00%)  0 1/67 (1.49%)  1 1/67 (1.49%)  1 3/50 (6.00%)  6 0/49 (0.00%)  0 0/66 (0.00%)  0 1/55 (1.82%)  1 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1
Folliculitis * 1  0/65 (0.00%)  0 1/67 (1.49%)  2 1/67 (1.49%)  1 1/50 (2.00%)  1 0/49 (0.00%)  0 4/66 (6.06%)  4 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Gastroenteritis * 1  2/65 (3.08%)  2 0/67 (0.00%)  0 1/67 (1.49%)  1 3/50 (6.00%)  3 1/49 (2.04%)  1 1/66 (1.52%)  1 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Nasopharyngitis * 1  8/65 (12.31%)  9 10/67 (14.93%)  11 16/67 (23.88%)  20 5/50 (10.00%)  8 5/49 (10.20%)  5 14/66 (21.21%)  20 3/55 (5.45%)  3 0/43 (0.00%)  0 8/187 (4.28%)  10 0/6 (0.00%)  0 0/2 (0.00%)  0
Upper respiratory tract infection * 1  5/65 (7.69%)  6 10/67 (14.93%)  11 5/67 (7.46%)  8 8/50 (16.00%)  8 6/49 (12.24%)  7 8/66 (12.12%)  8 4/55 (7.27%)  4 2/43 (4.65%)  2 9/187 (4.81%)  10 0/6 (0.00%)  0 0/2 (0.00%)  0
Urinary tract infection * 1  4/65 (6.15%)  5 4/67 (5.97%)  6 2/67 (2.99%)  2 2/50 (4.00%)  2 3/49 (6.12%)  3 3/66 (4.55%)  3 1/55 (1.82%)  2 3/43 (6.98%)  4 12/187 (6.42%)  16 1/6 (16.67%)  1 1/2 (50.00%)  1
COVID-19 * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 2/187 (1.07%)  2 0/6 (0.00%)  0 1/2 (50.00%)  1
Influenza * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 3/55 (5.45%)  3 0/43 (0.00%)  0 2/187 (1.07%)  2 0/6 (0.00%)  0 0/2 (0.00%)  0
Onychomycosis * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1
Investigations                       
Blood creatine phosphokinase increased * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 3/55 (5.45%)  3 4/43 (9.30%)  5 3/187 (1.60%)  3 0/6 (0.00%)  0 0/2 (0.00%)  0
Metabolism and nutrition disorders                       
Hypercholesterolaemia * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders                       
Back pain * 1  3/65 (4.62%)  3 3/67 (4.48%)  3 6/67 (8.96%)  8 0/50 (0.00%)  0 1/49 (2.04%)  1 3/66 (4.55%)  3 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Spinal segmental dysfunction * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
Nervous system disorders                       
Headache * 1  4/65 (6.15%)  4 7/67 (10.45%)  9 8/67 (11.94%)  8 1/50 (2.00%)  2 4/49 (8.16%)  5 8/66 (12.12%)  10 4/55 (7.27%)  4 3/43 (6.98%)  3 8/187 (4.28%)  8 0/6 (0.00%)  0 0/2 (0.00%)  0
Psychiatric disorders                       
Insomnia * 1  1/65 (1.54%)  1 0/67 (0.00%)  0 1/67 (1.49%)  1 3/50 (6.00%)  3 0/49 (0.00%)  0 1/66 (1.52%)  1 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                       
Cough * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 3/55 (5.45%)  3 2/43 (4.65%)  2 3/187 (1.60%)  3 0/6 (0.00%)  0 0/2 (0.00%)  0
Epistaxis * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders                       
Acne * 1  4/65 (6.15%)  4 1/67 (1.49%)  1 4/67 (5.97%)  4 1/50 (2.00%)  1 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Dry skin * 1  1/65 (1.54%)  1 4/67 (5.97%)  4 0/67 (0.00%)  0 2/50 (4.00%)  2 1/49 (2.04%)  1 2/66 (3.03%)  2 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Pruritus * 1  3/65 (4.62%)  3 2/67 (2.99%)  2 2/67 (2.99%)  2 1/50 (2.00%)  1 2/49 (4.08%)  2 5/66 (7.58%)  5 0/55 (0.00%)  0 3/43 (6.98%)  3 5/187 (2.67%)  6 0/6 (0.00%)  0 0/2 (0.00%)  0
Urticaria * 1  2/65 (3.08%)  3 3/67 (4.48%)  6 1/67 (1.49%)  1 0/50 (0.00%)  0 3/49 (6.12%)  4 0/66 (0.00%)  0 0/55 (0.00%)  0 0/43 (0.00%)  0 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Photosensitivity reaction * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 3/43 (6.98%)  4 0/187 (0.00%)  0 0/6 (0.00%)  0 0/2 (0.00%)  0
Rash * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 0/55 (0.00%)  0 1/43 (2.33%)  1 1/187 (0.53%)  3 0/6 (0.00%)  0 1/2 (50.00%)  1
Vascular disorders                       
Hypertension * 1  0/65 (0.00%)  0 0/67 (0.00%)  0 0/67 (0.00%)  0 0/50 (0.00%)  0 0/49 (0.00%)  0 0/66 (0.00%)  0 1/55 (1.82%)  1 0/43 (0.00%)  0 2/187 (1.07%)  2 1/6 (16.67%)  1 0/2 (0.00%)  0
1
Term from vocabulary, MedDRA 24.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03715829    
Other Study ID Numbers: B7981019
2018-001271-20 ( EudraCT Number )
First Submitted: October 19, 2018
First Posted: October 23, 2018
Results First Submitted: January 10, 2022
Results First Posted: March 25, 2022
Last Update Posted: March 25, 2022