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Trial record 1 of 1 for:    B7451036
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JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis (JADE TEEN)

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: NCT03796676
Recruitment Status : Completed
First Posted : January 8, 2019
Results First Posted : June 4, 2021
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: Placebo
Drug: PF-04965842
Drug: PF04965842
Enrollment 287
Recruitment Details  
Pre-assignment Details A total of 287 adolescent participants were randomized to the study, and 285 adolescent participants received study treatment, including 96 participants in the placebo group, 95 participants in the abrocitinib 100 mg QD group, and 94 participants in the abrocitinib 200 mg QD group.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description Participants received two PF-04965842-matching placebo tablets QD Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD Participants received two PF-04965842 100 mg tablets QD
Period Title: Overall Study
Started 96 95 94
Completed 90 92 91
Not Completed 6 3 3
Reason Not Completed
Adverse Event             2             1             2
Lost to Follow-up             2             1             0
Protocol Violation             0             0             1
Withdrawal by Subject             1             1             0
Participant did not complete Week 16 due to COVID-19 impact             1             0             0
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD Total
Hide Arm/Group Description Participants received two PF-04965842-matching placebo tablets QD Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD Participants received two PF-04965842 100 mg tablets QD Total of all reporting groups
Overall Number of Baseline Participants 96 95 94 285
Hide Baseline Analysis Population Description
Baseline analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 95 participants 94 participants 285 participants
14.8  (1.7) 15.1  (1.8) 14.7  (1.8) 14.9  (1.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 95 participants 94 participants 285 participants
Female
52
  54.2%
50
  52.6%
38
  40.4%
140
  49.1%
Male
44
  45.8%
45
  47.4%
56
  59.6%
145
  50.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 95 participants 94 participants 285 participants
Hispanic or Latino
25
  26.0%
26
  27.4%
25
  26.6%
76
  26.7%
Not Hispanic or Latino
65
  67.7%
63
  66.3%
69
  73.4%
197
  69.1%
Unknown or Not Reported
6
   6.3%
6
   6.3%
0
   0.0%
12
   4.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 95 participants 94 participants 285 participants
White
56
  58.3%
52
  54.7%
52
  55.3%
160
  56.1%
Black or African American
3
   3.1%
9
   9.5%
5
   5.3%
17
   6.0%
Asian
32
  33.3%
31
  32.6%
31
  33.0%
94
  33.0%
American Indian or Alaska Native
1
   1.0%
3
   3.2%
4
   4.3%
8
   2.8%
Native Hawaiian or Other Pacific Islander
1
   1.0%
0
   0.0%
1
   1.1%
2
   0.7%
Multiracial
1
   1.0%
0
   0.0%
1
   1.1%
2
   0.7%
Not reported
2
   2.1%
0
   0.0%
0
   0.0%
2
   0.7%
1.Primary Outcome
Title Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12
Hide Description The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 94 89 93
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
24.5
(15.8 to 33.2)
41.6
(31.3 to 51.8)
46.2
(36.1 to 56.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 100mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0147
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 16.7
Confidence Interval (2-Sided) 95%
3.5 to 29.9
Estimation Comments Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0030
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 20.6
Confidence Interval (2-Sided) 95%
7.3 to 33.9
Estimation Comments Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo
2.Primary Outcome
Title Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12
Hide Description The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 94 89 93
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
41.5
(31.5 to 51.4)
68.5
(58.9 to 78.2)
72.0
(62.9 to 81.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 100mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 26.5
Confidence Interval (2-Sided) 95%
13.1 to 39.8
Estimation Comments Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 29.4
Confidence Interval (2-Sided) 95%
16.3 to 42.5
Estimation Comments Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo
3.Secondary Outcome
Title Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12
Hide Description PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.
Time Frame Baseline, Weeks 2, 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 95 92 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 95 participants 92 participants 88 participants
12.6
(6.0 to 19.3)
27.2
(18.1 to 36.3)
38.6
(28.5 to 48.8)
Week 4 Number Analyzed 92 participants 89 participants 84 participants
20.7
(12.4 to 28.9)
31.5
(21.8 to 41.1)
50.0
(39.3 to 60.7)
Week 12 Number Analyzed 84 participants 76 participants 74 participants
29.8
(20.0 to 39.5)
52.6
(41.4 to 63.9)
55.4
(44.1 to 66.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 100mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0119
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 14.7
Confidence Interval 95%
3.5 to 25.9
Estimation Comments Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 100 mg minus placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 26.1
Confidence Interval (2-Sided) 95%
13.9 to 38.3
Estimation Comments Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 200 mg minus placebo
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 100mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0971
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 10.9
Confidence Interval (2-Sided) 95%
-1.8 to 23.6
Estimation Comments Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 100 mg minus placebo
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 29.4
Confidence Interval (2-Sided) 95%
16.0 to 42.9
Estimation Comments Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 200 mg minus placebo
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 100mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 22.8
Confidence Interval (2-Sided) 95%
8.0 to 37.7
Estimation Comments Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value 25.6
Confidence Interval (2-Sided) 95%
10.6 to 40.6
Estimation Comments Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo
4.Secondary Outcome
Title Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12
Hide Description The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 95 95 93
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-2.0
(-2.4 to -1.6)
-2.5
(-2.9 to -2.1)
-2.7
(-3.1 to -2.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 100mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0664
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.1 to 0.0
Estimation Comments The least squares mean difference at Week 12 was calculated by PF-04965842 100 mg minus placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0142
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.3 to -0.1
Estimation Comments The least squares mean difference at Week 12 was calculated by PF-04965842 200 mg minus placebo
5.Secondary Outcome
Title Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
Hide Description The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
Time Frame Baseline, Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 92 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 91 participants 92 participants 94 participants
1.1
(0.0 to 3.2)
6.5
(1.5 to 11.6)
12.8
(6.0 to 19.5)
Week 4 Number Analyzed 96 participants 92 participants 94 participants
3.1
(0.0 to 6.6)
19.6
(11.5 to 27.7)
38.3
(28.5 to 48.1)
Week 8 Number Analyzed 94 participants 91 participants 92 participants
16.0
(8.6 to 23.4)
30.8
(21.3 to 40.3)
48.9
(38.7 to 59.1)
6.Secondary Outcome
Title Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12
Hide Description The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time Frame Baseline, Weeks 2, 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 92 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 91 participants 92 participants 94 participants
4.4
(0.2 to 8.6)
19.6
(11.5 to 27.7)
25.5
(16.7 to 34.3)
Week 4 Number Analyzed 96 participants 92 participants 94 participants
14.6
(7.5 to 21.6)
41.3
(31.2 to 51.4)
63.8
(54.1 to 73.5)
Week 8 Number Analyzed 93 participants 91 participants 92 participants
33.3
(23.8 to 42.9)
60.4
(50.4 to 70.5)
68.5
(59.0 to 78.0)
7.Secondary Outcome
Title Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline
Hide Description The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 92 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 91 participants 92 participants 94 participants
24.2
(15.4 to 33.0)
55.4
(45.3 to 65.6)
64.9
(55.2 to 74.5)
Week 4 Number Analyzed 96 participants 92 participants 94 participants
51.0
(41.0 to 61.0)
75.0
(66.2 to 83.8)
81.9
(74.1 to 89.7)
Week 8 Number Analyzed 93 participants 91 participants 92 participants
65.6
(55.9 to 75.2)
85.7
(78.5 to 92.9)
82.6
(74.9 to 90.4)
Week 12 Number Analyzed 94 participants 89 participants 93 participants
69.1
(59.8 to 78.5)
87.6
(80.8 to 94.5)
87.1
(80.3 to 93.9)
8.Secondary Outcome
Title Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline
Hide Description The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 92 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 91 participants 92 participants 94 participants
0
(0.0 to 4.0)
8.7
(2.9 to 14.5)
10.6
(4.4 to 16.9)
Week 4 Number Analyzed 96 participants 92 participants 94 participants
2.1
(0.0 to 4.9)
17.4
(9.6 to 25.1)
30.9
(21.5 to 40.2)
Week 8 Number Analyzed 93 participants 91 participants 92 participants
14.0
(6.9 to 21.0)
29.7
(20.3 to 39.1)
40.2
(30.2 to 50.2)
Week 12 Number Analyzed 94 participants 89 participants 93 participants
18.1
(10.3 to 25.9)
41.6
(31.3 to 51.8)
49.5
(39.3 to 59.6)
9.Secondary Outcome
Title Percentage of Participants Achieving EASI Response =100% Improvement From Baseline
Hide Description The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 92 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 91 participants 92 participants 94 participants
0
(0.0 to 4.0)
1.1
(0.0 to 3.2)
0
(0.0 to 3.8)
Week 4 Number Analyzed 96 participants 92 participants 94 participants
0
(0.0 to 3.8)
2.2
(0.0 to 5.2)
5.3
(0.8 to 9.9)
Week 8 Number Analyzed 93 participants 91 participants 92 participants
0
(0.0 to 3.9)
3.3
(0.0 to 7.0)
9.8
(3.7 to 15.9)
Week 12 Number Analyzed 94 participants 89 participants 93 participants
2.1
(0.0 to 5.0)
2.2
(0.0 to 5.3)
8.6
(2.9 to 14.3)
10.Secondary Outcome
Title Percent Change From Baseline in EASI Score
Hide Description The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
Time Frame Baseline, Weeks 2, 4, 8 and 12
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Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 92 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
Week 2 Number Analyzed 91 participants 92 participants 94 participants
-27.6
(-34.0 to -21.2)
-51.5
(-57.9 to -45.1)
-54.5
(-61.0 to -48.0)
Week 4 Number Analyzed 96 participants 92 participants 94 participants
-41.7
(-48.3 to -35.1)
-66.1
(-72.7 to -59.4)
-74.3
(-81.0 to -67.5)
Week 8 Number Analyzed 93 participants 91 participants 92 participants
-57.6
(-63.4 to -51.8)
-72.6
(-78.4 to -66.8)
-77.8
(-83.7 to -71.9)
Week 12 Number Analyzed 94 participants 89 participants 93 participants
-63.7
(-69.5 to -57.9)
-77.3
(-83.1 to -71.5)
-80.6
(-86.5 to -74.8)
11.Secondary Outcome
Title Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12
Hide Description PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.
Time Frame Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 84 83 82
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 2 Number Analyzed 81 participants 71 participants 77 participants
1.2
(0.0 to 3.6)
2.8
(0.0 to 6.7)
3.9
(0.0 to 8.2)
Day 3 Number Analyzed 79 participants 79 participants 78 participants
0
(0.0 to 4.6)
5.1
(0.2 to 9.9)
7.7
(1.8 to 13.6)
Day 4 Number Analyzed 81 participants 78 participants 77 participants
4.9
(0.2 to 9.7)
11.5
(4.4 to 18.6)
14.3
(6.5 to 22.1)
Day 5 Number Analyzed 72 participants 82 participants 81 participants
6.9
(1.1 to 12.8)
12.2
(5.1 to 19.3)
18.5
(10.1 to 27.0)
Day 6 Number Analyzed 80 participants 81 participants 80 participants
8.8
(2.6 to 14.9)
16.0
(8.1 to 24.0)
21.3
(12.3 to 30.2)
Day 7 Number Analyzed 79 participants 81 participants 80 participants
10.1
(3.5 to 16.8)
16.0
(8.1 to 24.0)
21.3
(12.3 to 30.2)
Day 8 Number Analyzed 75 participants 75 participants 76 participants
4.0
(0.0 to 8.4)
17.3
(8.8 to 25.9)
25.0
(15.3 to 34.7)
Day 9 Number Analyzed 83 participants 75 participants 80 participants
6.0
(0.9 to 11.1)
16.0
(7.7 to 24.3)
25.0
(15.5 to 34.5)
Day 10 Number Analyzed 84 participants 77 participants 80 participants
8.3
(2.4 to 14.2)
15.6
(7.5 to 23.7)
28.8
(18.8 to 38.7)
Day 11 Number Analyzed 79 participants 77 participants 74 participants
7.6
(1.8 to 13.4)
20.8
(11.7 to 29.8)
27.0
(16.9 to 37.1)
Day 12 Number Analyzed 74 participants 72 participants 72 participants
10.8
(3.7 to 17.9)
22.2
(12.6 to 31.8)
23.6
(13.8 to 33.4)
Day 13 Number Analyzed 80 participants 80 participants 77 participants
10.0
(3.4 to 16.6)
26.3
(16.6 to 35.9)
31.2
(20.8 to 41.5)
Day 14 Number Analyzed 84 participants 81 participants 74 participants
9.5
(3.2 to 15.8)
24.7
(15.3 to 34.1)
32.4
(21.8 to 43.1)
Day 15 Number Analyzed 84 participants 83 participants 82 participants
14.3
(6.8 to 21.8)
27.7
(18.1 to 37.3)
37.8
(27.3 to 48.3)
12.Secondary Outcome
Title Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus
Hide Description PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10).
Time Frame Baseline to Week 16
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Hide Analysis Population Description
The Full Analysis Set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants in the FAS with a baseline numeric rating score for severity of pruritus >=4 were included in the analysis.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 93 90
Median (95% Confidence Interval)
Unit of Measure: Days
90.0 [1] 
(62.0 to NA)
70.0
(30.0 to 85.0)
29.0
(15.0 to 61.0)
[1]
The upper limit was not evaluable as too few events were observed.
13.Secondary Outcome
Title Percent Change From Baseline in PP-NRS for Severity of Pruritus
Hide Description PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10).
Time Frame Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 84 83 82
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
Day 2 Number Analyzed 81 participants 71 participants 77 participants
-0.9
(-5.5 to 3.6)
-9.5
(-14.2 to -4.8)
-5.4
(-10.0 to -0.7)
Day 3 Number Analyzed 79 participants 79 participants 78 participants
-1.1
(-6.0 to 3.8)
-11.3
(-16.2 to -6.4)
-10.2
(-15.2 to -5.2)
Day 4 Number Analyzed 81 participants 78 participants 77 participants
-5.0
(-10.6 to 0.5)
-14.6
(-20.2 to -9.1)
-14.7
(-20.3 to -9.1)
Day 5 Number Analyzed 72 participants 82 participants 81 participants
-9.5
(-15.8 to -3.2)
-16.1
(-22.3 to -9.9)
-17.6
(-23.9 to -11.3)
Day 6 Number Analyzed 80 participants 81 participants 80 participants
-8.7
(-15.2 to -2.2)
-18.5
(-25.0 to -12.1)
-18.7
(-25.3 to -12.1)
Day 7 Number Analyzed 79 participants 81 participants 80 participants
-12.3
(-19.4 to -5.2)
-20.0
(-27.1 to -12.9)
-18.8
(-26.0 to -11.6)
Day 8 Number Analyzed 75 participants 75 participants 76 participants
-10.6
(-17.9 to -3.3)
-21.6
(-28.9 to -14.2)
-22.7
(-30.2 to -15.3)
Day 9 Number Analyzed 83 participants 75 participants 80 participants
-9.9
(-17.6 to -2.3)
-20.9
(-28.7 to -13.2)
-21.7
(-29.5 to -13.9)
Day 10 Number Analyzed 84 participants 77 participants 80 participants
-10.8
(-17.8 to -3.8)
-26.1
(-33.1 to -19.0)
-28.0
(-35.1 to -20.8)
Day 11 Number Analyzed 79 participants 77 participants 74 participants
-10.7
(-17.7 to -3.7)
-26.5
(-33.5 to -19.4)
-26.3
(-33.5 to -19.1)
Day 12 Number Analyzed 74 participants 72 participants 72 participants
-11.0
(-18.0 to -4.0)
-27.0
(-34.0 to -20.0)
-28.9
(-36.1 to -21.8)
Day 13 Number Analyzed 80 participants 80 participants 77 participants
-14.1
(-20.4 to -7.8)
-25.2
(-31.5 to -18.8)
-32.5
(-39.0 to -26.0)
Day 14 Number Analyzed 84 participants 81 participants 74 participants
-12.0
(-18.1 to -5.8)
-29.4
(-35.5 to -23.2)
-35.3
(-41.6 to -29.0)
Day 15 Number Analyzed 84 participants 83 participants 82 participants
-15.8
(-22.7 to -8.8)
-30.7
(-37.7 to -23.7)
-33.4
(-40.5 to -26.3)
14.Secondary Outcome
Title Change From Baseline in Percentage Body Surface Area (BSA)
Hide Description BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Week 2
-10.9
(-14.0 to -7.8)
-21.0
(-24.1 to -17.9)
-20.7
(-23.8 to -17.6)
Week 4
-15.1
(-18.4 to -11.7)
-27.7
(-31.0 to -24.3)
-32.6
(-36.0 to -29.1)
Week 8
-21.8
(-25.3 to -18.3)
-32.6
(-36.1 to -29.1)
-34.1
(-37.7 to -30.6)
Week 12
-24.2
(-27.8 to -20.7)
-34.4
(-38.0 to -30.8)
-35.2
(-38.8 to -31.6)
15.Secondary Outcome
Title Percent Change From Baseline in Percentage BSA
Hide Description BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
Week 2
-20.6
(-26.7 to -14.5)
-40.4
(-46.5 to -34.3)
-42.2
(-48.3 to -36.1)
Week 4
-29.0
(-36.3 to -21.8)
-55.4
(-62.7 to -48.1)
-66.0
(-73.4 to -58.6)
Week 8
-46.0
(-52.6 to -39.3)
-65.7
(-72.4 to -59.1)
-69.5
(-76.3 to -62.8)
Week 12
-53.4
(-60.1 to -46.7)
-71.4
(-78.2 to -64.7)
-72.6
(-79.3 to -65.8)
16.Secondary Outcome
Title Percentage of Participants Achieving Percentage BSA < 5% at Week 12
Hide Description BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 94 89 93
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
24.5
(15.8 to 33.2)
38.2
(28.1 to 48.3)
36.6
(26.8 to 46.3)
17.Secondary Outcome
Title Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline
Hide Description SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 93 93
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 93 participants 93 participants 93 participants
8.6
(2.9 to 14.3)
22.6
(14.1 to 31.1)
29.0
(19.8 to 38.3)
Week 4 Number Analyzed 96 participants 93 participants 92 participants
24.0
(15.4 to 32.5)
44.1
(34.0 to 54.2)
64.1
(54.3 to 73.9)
Week 8 Number Analyzed 94 participants 93 participants 92 participants
34.0
(24.5 to 43.6)
65.6
(55.9 to 75.2)
75.0
(66.2 to 83.8)
Week 12 Number Analyzed 93 participants 90 participants 92 participants
37.6
(27.8 to 47.5)
75.6
(66.7 to 84.4)
73.9
(64.9 to 82.9)
18.Secondary Outcome
Title Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline
Hide Description SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 93 93
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 93 participants 93 participants 93 participants
0
(0.0 to 3.9)
5.4
(0.8 to 10.0)
7.5
(2.2 to 12.9)
Week 4 Number Analyzed 96 participants 93 participants 92 participants
0
(0.0 to 3.8)
11.8
(5.3 to 18.4)
21.7
(13.3 to 30.2)
Week 8 Number Analyzed 94 participants 93 participants 92 participants
8.5
(2.9 to 14.2)
17.2
(9.5 to 24.9)
33.7
(24.0 to 43.4)
Week 12 Number Analyzed 93 participants 90 participants 92 participants
12.9
(6.1 to 19.7)
36.7
(26.7 to 46.6)
34.8
(25.1 to 44.5)
19.Secondary Outcome
Title Change From Baseline in SCORAD Total Score
Hide Description SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 93
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Week 2
-12.3
(-15.4 to -9.2)
-24.6
(-27.7 to -21.6)
-25.8
(-28.9 to -22.7)
Week 4
-20.2
(-23.3 to -17.0)
-32.4
(-35.5 to -29.2)
-38.0
(-41.2 to -34.8)
Week 8
-26.6
(-30.0 to -23.2)
-37.3
(-40.7 to -33.9)
-41.5
(-45.0 to -38.0)
Week 12
-30.2
(-33.9 to -26.4)
-40.9
(-44.7 to -37.2)
-42.9
(-46.7 to -39.1)
20.Secondary Outcome
Title Percent Change From Baseline in SCORAD Total Score
Hide Description SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 93
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
Week 2
-18.7
(-23.1 to -14.2)
-36.1
(-40.6 to -31.7)
-38.7
(-43.2 to -34.2)
Week 4
-30.0
(-34.5 to -25.5)
-47.4
(-52.0 to -42.9)
-56.9
(-61.6 to -52.3)
Week 8
-39.9
(-44.9 to -34.8)
-54.0
(-59.0 to -48.9)
-62.0
(-67.2 to -56.9)
Week 12
-44.4
(-50.1 to -38.8)
-59.2
(-64.9 to -53.6)
-64.3
(-70.1 to -58.6)
21.Secondary Outcome
Title Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss
Hide Description SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 93
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Week 2
-0.9
(-1.4 to -0.4)
-2.1
(-2.6 to -1.6)
-2.6
(-3.1 to -2.1)
Week 4
-1.8
(-2.3 to -1.3)
-2.9
(-3.3 to -2.4)
-3.4
(-3.9 to -2.9)
Week 8
-2.2
(-2.7 to -1.7)
-3.3
(-3.8 to -2.9)
-3.7
(-4.2 to -3.2)
Week 12
-2.7
(-3.2 to -2.2)
-3.5
(-3.9 to -3.0)
-3.9
(-4.4 to -3.4)
22.Secondary Outcome
Title Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss
Hide Description SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 93
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent change
Week 2
2.6
(-101.2 to 106.3)
65.1
(-39.2 to 169.4)
-36.5
(-140.7 to 67.8)
Week 4
-20.0
(-35.2 to -4.9)
-35.2
(-50.7 to -19.8)
-53.4
(-69.1 to -37.8)
Week 8
-24.7
(-60.1 to 10.8)
-44.2
(-79.9 to -8.5)
-30.6
(-66.7 to 5.5)
Week 12
-39.5
(-77.7 to -1.3)
-49.8
(-88.3 to -11.3)
-35.2
(-74.1 to 3.7)
23.Secondary Outcome
Title Number of Days When a Corticosteroid Not Used up to Day 88
Hide Description [Not Specified]
Time Frame Baseline to Day 88
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The analysis population included all participants in the FAS who had used corticosteroid during treatment period.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 83 89 82
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Days
6.8
(2.0 to 11.6)
10.9
(6.2 to 15.5)
15.1
(10.2 to 19.9)
24.Secondary Outcome
Title Change From Baseline in Children's Dermatology Life Quality Index (DLQI)
Hide Description The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Week 2
-4.2
(-5.1 to -3.3)
-6.1
(-7.1 to -5.2)
-6.3
(-7.2 to -5.3)
Week 4
-5.4
(-6.3 to -4.5)
-7.3
(-8.2 to -6.4)
-7.6
(-8.6 to -6.7)
Week 8
-6.1
(-7.0 to -5.1)
-8.1
(-9.1 to -7.1)
-8.2
(-9.2 to -7.2)
Week 12
-6.3
(-7.4 to -5.3)
-8.6
(-9.6 to -7.5)
-8.7
(-9.7 to -7.6)
25.Secondary Outcome
Title Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI
Hide Description The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 95 92 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 91 participants 91 participants 94 participants
61.5
(51.5 to 71.5)
73.6
(64.6 to 82.7)
71.3
(62.1 to 80.4)
Week 4 Number Analyzed 95 participants 91 participants 94 participants
73.7
(64.8 to 82.5)
82.4
(74.6 to 90.2)
73.4
(64.5 to 82.3)
Week 8 Number Analyzed 93 participants 92 participants 93 participants
71.0
(61.7 to 80.2)
85.9
(78.8 to 93.0)
79.6
(71.4 to 87.8)
Week 12 Number Analyzed 93 participants 89 participants 93 participants
67.7
(58.2 to 77.2)
80.9
(72.7 to 89.1)
78.5
(70.1 to 86.8)
26.Secondary Outcome
Title Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)
Hide Description The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Week 2
-1.2
(-1.7 to -0.7)
-1.6
(-2.1 to -1.1)
-1.3
(-1.8 to -0.8)
Week 4
-1.5
(-2.1 to -1.0)
-1.6
(-2.2 to -1.1)
-1.9
(-2.5 to -1.3)
Week 8
-1.7
(-2.3 to -1.1)
-2.1
(-2.7 to -1.5)
-2.2
(-2.8 to -1.5)
Week 12
-2.1
(-2.7 to -1.5)
-2.0
(-2.6 to -1.4)
-2.4
(-3.0 to -1.8)
27.Secondary Outcome
Title Change From Baseline in Depression of HADS
Hide Description The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Week 2
-0.8
(-1.3 to -0.3)
-1.2
(-1.7 to -0.8)
-0.8
(-1.3 to -0.3)
Week 4
-0.8
(-1.3 to -0.3)
-1.3
(-1.8 to -0.8)
-1.3
(-1.8 to -0.8)
Week 8
-1.1
(-1.6 to -0.6)
-1.4
(-1.9 to -0.9)
-1.2
(-1.7 to -0.7)
Week 12
-1.0
(-1.5 to -0.5)
-1.4
(-1.9 to -0.8)
-1.2
(-1.7 to -0.6)
28.Secondary Outcome
Title Change From Baseline in Patient-Oriented Eczema Measure (POEM)
Hide Description The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 95 95 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Week 2
-3.4
(-4.7 to -2.1)
-6.9
(-8.2 to -5.6)
-8.2
(-9.5 to -6.9)
Week 4
-4.8
(-6.0 to -3.6)
-9.5
(-10.7 to -8.3)
-10.6
(-11.9 to -9.4)
Week 8
-5.4
(-6.7 to -4.0)
-10.0
(-11.4 to -8.7)
-10.6
(-12.0 to -9.3)
Week 12
-6.9
(-8.3 to -5.6)
-11.1
(-12.5 to -9.7)
-10.9
(-12.2 to -9.5)
29.Secondary Outcome
Title Change From Baseline in Dermatitis Family Impact (DFI) at Week 12
Hide Description The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" or "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 92 95 93
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-5.2
(-6.5 to -3.9)
-6.7
(-7.9 to -5.4)
-7.3
(-8.6 to -6.0)
30.Secondary Outcome
Title Change From Baseline in Patient Global Assessment (PtGA)
Hide Description The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Week 2
-0.4
(-0.6 to -0.3)
-0.7
(-0.9 to -0.6)
-1.0
(-1.1 to -0.8)
Week 4
-0.7
(-0.8 to -0.5)
-0.9
(-1.1 to -0.8)
-1.2
(-1.4 to -1.1)
Week 8
-0.8
(-1.0 to -0.6)
-1.2
(-1.3 to -1.0)
-1.4
(-1.6 to -1.2)
Week 12
-0.9
(-1.1 to -0.7)
-1.4
(-1.6 to -1.2)
-1.6
(-1.8 to -1.4)
31.Secondary Outcome
Title Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA
Hide Description The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 93 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 92 participants 92 participants 94 participants
1.1
(0.0 to 3.2)
5.4
(0.8 to 10.1)
5.3
(0.8 to 9.9)
Week 4 Number Analyzed 96 participants 92 participants 94 participants
4.2
(0.2 to 8.2)
14.1
(7.0 to 21.2)
20.2
(12.1 to 28.3)
Week 8 Number Analyzed 94 participants 93 participants 93 participants
6.4
(1.4 to 11.3)
22.6
(14.1 to 31.1)
26.9
(17.9 to 35.9)
Week 12 Number Analyzed 94 participants 90 participants 93 participants
10.6
(4.4 to 16.9)
30.0
(20.5 to 39.5)
36.6
(26.8 to 46.3)
32.Secondary Outcome
Title Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score
Hide Description The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine).
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Week 2
7.140
(3.787 to 10.492)
11.241
(7.882 to 14.601)
12.141
(8.763 to 15.520)
Week 4
8.784
(5.625 to 11.943)
13.222
(10.020 to 16.423)
14.677
(11.438 to 17.917)
Week 8
8.415
(4.888 to 11.941)
14.502
(10.977 to 18.028)
14.653
(11.076 to 18.231)
Week 12
9.944
(6.373 to 13.515)
14.226
(10.624 to 17.828)
15.756
(12.153 to 19.360)
33.Secondary Outcome
Title Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12
Hide Description The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 94
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
2.5
(1.1 to 3.9)
4.5
(3.0 to 5.9)
4.3
(2.9 to 5.7)
34.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 94
Measure Type: Count of Participants
Unit of Measure: Participants
All-causality TEAEs
50
  52.1%
54
  56.8%
59
  62.8%
Treatment-related TEAEs
16
  16.7%
20
  21.1%
31
  33.0%
35.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 94
Measure Type: Count of Participants
Unit of Measure: Participants
All-causality SAEs
2
   2.1%
0
   0.0%
1
   1.1%
Treatment-related SAEs
0
   0.0%
0
   0.0%
0
   0.0%
36.Secondary Outcome
Title Number of Participants Who Discontinued From the Study Due to TEAEs
Hide Description An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 94
Measure Type: Count of Participants
Unit of Measure: Participants
All-causality TEAEs
2
   2.1%
1
   1.1%
2
   2.1%
Treatment-related TEAEs
0
   0.0%
0
   0.0%
2
   2.1%
37.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Hide Description Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants with at least one observation of the given laboratory test.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 93
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin (g/dL) <0.8*LLN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Hematocrit (%) <0.8*LLN Number Analyzed 96 participants 93 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Erythrocytes (10^6/mm^3) <0.8*LLN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Reticulocytes (10^3/mm^3) <0.5*LLN Number Analyzed 68 participants 68 participants 70 participants
0
   0.0%
0
   0.0%
0
   0.0%
Reticulocytes (10^3/mm^3) >1.5*ULN Number Analyzed 68 participants 68 participants 70 participants
0
   0.0%
0
   0.0%
0
   0.0%
Ery. Mean Corpuscular Volume (10^-15L) <0.9*LLN Number Analyzed 96 participants 93 participants 93 participants
1
   1.0%
1
   1.1%
0
   0.0%
Ery. Mean Corpuscular Volume (10^-15L) >1.1*ULN Number Analyzed 96 participants 93 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9*LLN Number Analyzed 96 participants 95 participants 93 participants
1
   1.0%
1
   1.1%
0
   0.0%
Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN Number Analyzed 96 participants 93 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN Number Analyzed 96 participants 93 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Platelets (10^3/mm^3) <0.5*LLN Number Analyzed 96 participants 95 participants 93 participants
1
   1.0%
0
   0.0%
0
   0.0%
Platelets (10^3/mm^3) >1.75*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Reticulocytes/Erythrocytes (%) <0.5*LLN Number Analyzed 68 participants 68 participants 70 participants
0
   0.0%
0
   0.0%
0
   0.0%
Reticulocytes/Erythrocytes (%) >1.5*ULN Number Analyzed 68 participants 68 participants 70 participants
0
   0.0%
0
   0.0%
1
   1.4%
Leukocytes (10^3/mm^3) <0.6*LLN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Leukocytes (10^3/mm^3) >1.5*ULN Number Analyzed 96 participants 95 participants 93 participants
1
   1.0%
0
   0.0%
0
   0.0%
Lymphocytes (10^3/mm^3) <0.8*LLN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
1
   1.1%
Lymphocytes (10^3/mm^3) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
1
   1.1%
Lymphocytes/Leukocytes (%) <0.8*LLN Number Analyzed 96 participants 95 participants 93 participants
6
   6.3%
4
   4.2%
6
   6.5%
Lymphocytes/Leukocytes (%) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
1
   1.0%
1
   1.1%
4
   4.3%
Neutrophils (10^3/mm^3) <0.8*LLN Number Analyzed 96 participants 95 participants 93 participants
1
   1.0%
2
   2.1%
1
   1.1%
Neutrophils (10^3/mm^3) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
6
   6.3%
5
   5.3%
3
   3.2%
Neutrophils/Leukocytes (%) <0.8*LLN Number Analyzed 96 participants 95 participants 93 participants
5
   5.2%
3
   3.2%
7
   7.5%
Neutrophils/Leukocytes (%) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Basophils (10^3/mm^3) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
3
   3.1%
0
   0.0%
0
   0.0%
Basophils/Leukocytes (%) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
35
  36.5%
24
  25.3%
27
  29.0%
Eosinophils (10^3/mm^3) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
63
  65.6%
55
  57.9%
39
  41.9%
Eosinophils/Leukocytes (%) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
61
  63.5%
62
  65.3%
47
  50.5%
Monocytes (10^3/mm^3) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
1
   1.0%
0
   0.0%
0
   0.0%
Monocytes/Leukocytes (%) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
7
   7.3%
11
  11.6%
6
   6.5%
Activated Partial Thromboplastin Time (sec) >1.1*ULN Number Analyzed 96 participants 95 participants 93 participants
2
   2.1%
4
   4.2%
4
   4.3%
Prothrombin Time (sec) >1.1*ULN Number Analyzed 96 participants 95 participants 93 participants
4
   4.2%
6
   6.3%
8
   8.6%
Prothrombin Intl.Normalized Ratio >1.1*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin (mg/dL) >1.5*ULN Number Analyzed 96 participants 95 participants 93 participants
1
   1.0%
4
   4.2%
0
   0.0%
Direct Bilirubin (mg/dL) >1.5*ULN Number Analyzed 96 participants 93 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Indirect Bilirubin (mg/dL) >1.5*ULN Number Analyzed 96 participants 93 participants 93 participants
1
   1.0%
2
   2.2%
0
   0.0%
Aspartate Aminotransferase (U/L) >3.0*ULN Number Analyzed 96 participants 95 participants 93 participants
1
   1.0%
1
   1.1%
3
   3.2%
Alanine Aminotransferase (U/L) >3.0*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
3
   3.2%
1
   1.1%
Gamma Glutamyl Transferase (U/L) >3.0*ULN Number Analyzed 96 participants 95 participants 93 participants
1
   1.0%
0
   0.0%
0
   0.0%
Lactate Dehydrogenase (U/L) >3.0*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
1
   1.1%
2
   2.2%
Alkaline Phosphatase (U/L) >3.0*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
1
   1.1%
Protein (g/dL) <0.8*LLN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Protein (g/dL) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
1
   1.1%
Albumin (g/dL) <0.8*LLN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Albumin (g/dL) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
3
   3.2%
Urea Nitrogen (mg/dL) >1.3*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine (mg/dL) >1.3*ULN Number Analyzed 96 participants 95 participants 93 participants
3
   3.1%
2
   2.1%
0
   0.0%
Urate (mg/dL) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
2
   2.1%
4
   4.2%
1
   1.1%
LDL Cholesterol (mg/dL) >1.2*ULN Number Analyzed 96 participants 95 participants 93 participants
2
   2.1%
2
   2.1%
3
   3.2%
Triglycerides (mg/dL) >1.3*ULN Number Analyzed 96 participants 95 participants 93 participants
17
  17.7%
11
  11.6%
13
  14.0%
Sodium (mEq/L) <0.95*LLN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Sodium (mEq/L) >1.05*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Potassium (mEq/L) <0.9*LLN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Potassium (mEq/L) >1.1*ULN Number Analyzed 96 participants 95 participants 93 participants
1
   1.0%
0
   0.0%
0
   0.0%
Chloride (mEq/L) <0.9*LLN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Chloride (mEq/L) >1.1*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Calcium (mg/dL) <0.9*LLN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Calcium (mg/dL) >1.1*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Bicarbonate (mEq/L) <0.9*LLN Number Analyzed 96 participants 95 participants 93 participants
1
   1.0%
1
   1.1%
0
   0.0%
Bicarbonate (mEq/L) >1.1*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Glucose (mg/dL) <0.6*LLN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Glucose (mg/dL) >1.5*ULN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
2
   2.1%
3
   3.2%
Creatine Kinase (U/L) >2.0*ULN Number Analyzed 96 participants 95 participants 93 participants
5
   5.2%
7
   7.4%
12
  12.9%
Cholesterol (mg/dL)>1.3*ULN Number Analyzed 96 participants 95 participants 93 participants
2
   2.1%
2
   2.1%
2
   2.2%
HDL Cholesterol (mg/dL) <0.8*LLN Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Urine Specific Gravity (scalar) <1.003 Number Analyzed 0 participants 1 participants 2 participants
0
0
   0.0%
0
   0.0%
Urine Specific Gravity (scalar) >1.030 Number Analyzed 0 participants 1 participants 2 participants
0
1
 100.0%
0
   0.0%
Urine pH (Scalar) <4.5 Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
0
   0.0%
0
   0.0%
Urine pH (Scalar) >8 Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
1
   1.1%
0
   0.0%
Urine Glucose >=1 Number Analyzed 96 participants 95 participants 93 participants
1
   1.0%
0
   0.0%
0
   0.0%
Urine Ketones >=1 Number Analyzed 96 participants 95 participants 93 participants
8
   8.3%
0
   0.0%
1
   1.1%
Urine Protein >=1 Number Analyzed 96 participants 95 participants 93 participants
4
   4.2%
5
   5.3%
0
   0.0%
Urine Hemoglobin >=1 Number Analyzed 96 participants 95 participants 93 participants
20
  20.8%
19
  20.0%
15
  16.1%
Urine Nitrite >=1 Number Analyzed 96 participants 95 participants 93 participants
0
   0.0%
1
   1.1%
0
   0.0%
Urine Leukocyte Esterase >=1 Number Analyzed 96 participants 95 participants 93 participants
7
   7.3%
14
  14.7%
17
  18.3%
Urine Erythrocytes (/HPF) >=20 Number Analyzed 49 participants 41 participants 44 participants
8
  16.3%
7
  17.1%
5
  11.4%
Urine Leukocytes (/HPF) >=20 Number Analyzed 57 participants 62 participants 54 participants
0
   0.0%
2
   3.2%
1
   1.9%
Urine Granular Casts (/LPF) >1 Number Analyzed 1 participants 0 participants 0 participants
1
 100.0%
 0 0
Urine Hyaline Casts (/LPF) >1 Number Analyzed 4 participants 3 participants 3 participants
2
  50.0%
1
  33.3%
1
  33.3%
Urine Bacteria >20 Number Analyzed 18 participants 22 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
38.Secondary Outcome
Title Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria
Hide Description A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 93
Measure Type: Count of Participants
Unit of Measure: Participants
QTcF Interval, Single Beat (msec) Value >500
0
   0.0%
0
   0.0%
0
   0.0%
QTcF Interval, Single Beat (msec) Change From Screening >60
0
   0.0%
0
   0.0%
0
   0.0%
39.Secondary Outcome
Title Categorization of Vital Signs Data Meeting Prespecified Criteria
Hide Description Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 96 95 93
Measure Type: Count of Participants
Unit of Measure: Participants
Diastolic Blood Pressure Value <50mmHg
3
   3.1%
1
   1.1%
9
   9.7%
Diastolic Blood Pressure Increase From Baseline >= 20mmHg
3
   3.1%
6
   6.3%
6
   6.5%
Diastolic Blood Pressure Decrease From Baseline >= 20mmHg
3
   3.1%
4
   4.2%
8
   8.6%
Pulse Rate Value <40 bpm
0
   0.0%
0
   0.0%
0
   0.0%
Pulse Rate Value >120 bpm
0
   0.0%
0
   0.0%
0
   0.0%
Systolic Blood Pressure Value <90mmHg
4
   4.2%
7
   7.4%
4
   4.3%
Systolic Blood Pressure Increase From Baseline >=30mmHg
2
   2.1%
1
   1.1%
2
   2.2%
Systolic Blood Pressure Decrease From Baseline >=30mmHg
2
   2.1%
1
   1.1%
2
   2.2%
40.Secondary Outcome
Title Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination
Hide Description The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution.
Time Frame 4 weeks post-vaccination with Tdap (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity sub-study analysis set included all participants who had completed 8 weeks of treatment and received Tdap vaccination. Number of Participants Analyzed refers to the number of participants evaluable in the analysis set at the specified visit.
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received two PF-04965842-matching placebo tablets QD
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 10 8 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Diphtheria IgG Antibody
14.00
(6.32 to 30.99)
6.51
(2.31 to 18.34)
34.61
(6.96 to 172.06)
Filamentous Hemagglutinin IgG
15.19
(4.89 to 47.16)
11.48
(2.65 to 49.69)
22.77
(7.26 to 71.45)
Fimbriae 2/3 IgG
1.93
(0.79 to 4.73)
1.11
(0.85 to 1.46)
1.47
(0.61 to 3.50)
Pertactin IgG
54.03
(14.67 to 199.03)
15.60
(5.77 to 42.14)
60.18
(12.79 to 283.08)
Pertussis Toxin IgG
6.94
(1.95 to 24.71)
10.17
(4.71 to 21.94)
33.16
(5.04 to 218.38)
Tetanus Toxoid IGG AB
8.36
(1.62 to 43.18)
16.26
(3.52 to 75.11)
48.41
(9.01 to 260.09)
41.Secondary Outcome
Title Plasma PF-04965842 Concentration at Week 8
Hide Description [Not Specified]
Time Frame 2 hours pre-dose at Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Samples from site 1173 were excluded from the analysis.
Arm/Group Title PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 72 62
Mean (Standard Deviation)
Unit of Measure: ng/mL
7.882  (26.350) 32.33  (76.506)
42.Secondary Outcome
Title Plasma PF-04965842 Concentration at Week 12
Hide Description [Not Specified]
Time Frame 2 hours post-dose at Week 12
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The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Samples from site 1173 were excluded from the analysis.
Arm/Group Title PF-04965842 100mg QD PF-04965842 200mg QD
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Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD
Participants received two PF-04965842 100 mg tablets QD
Overall Number of Participants Analyzed 59 50
Mean (Standard Deviation)
Unit of Measure: ng/mL
486.6  (403.69) 1271  (1000.4)
Time Frame 16 weeks
Adverse Event Reporting Description The same event may appear as both an AE and an SAE. 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. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
 
Arm/Group Title Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description Participants received two PF-04965842-matching placebo tablets QD Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD Participants received two PF-04965842 100 mg tablets QD
All-Cause Mortality
Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/96 (0.00%)      0/95 (0.00%)      0/94 (0.00%)    
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Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/96 (2.08%)      0/95 (0.00%)      1/94 (1.06%)    
Psychiatric disorders       
Anxiety * 1  0/96 (0.00%)  0 0/95 (0.00%)  0 1/94 (1.06%)  1
Skin and subcutaneous tissue disorders       
Angioedema * 1  1/96 (1.04%)  1 0/95 (0.00%)  0 0/94 (0.00%)  0
Dermatitis stopic * 1  1/96 (1.04%)  1 0/95 (0.00%)  0 0/94 (0.00%)  0
1
Term from vocabulary, MedDRA v23.0
*
Indicates events were collected by non-systematic assessment
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Frequency Threshold for Reporting Other Adverse Events 2%
Placebo PF-04965842 100mg QD PF-04965842 200mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/96 (43.75%)      40/95 (42.11%)      50/94 (53.19%)    
Blood and lymphatic system disorders       
Eosinophilia * 1  2/96 (2.08%)  2 0/95 (0.00%)  0 0/94 (0.00%)  0
Gastrointestinal disorders       
Abdominal Pain * 1  1/96 (1.04%)  1 1/95 (1.05%)  1 3/94 (3.19%)  3
Abdominal pain upper * 1  0/96 (0.00%)  0 0/95 (0.00%)  0 4/94 (4.26%)  5
Diarrhoea * 1  0/96 (0.00%)  0 2/95 (2.11%)  2 1/94 (1.06%)  1
Lip swelling * 1  2/96 (2.08%)  2 0/95 (0.00%)  0 0/94 (0.00%)  0
Nausea * 1  1/96 (1.04%)  2 7/95 (7.37%)  7 17/94 (18.09%)  27
Vomiting * 1  0/96 (0.00%)  0 4/95 (4.21%)  4 5/94 (5.32%)  7
General disorders       
Fatigue * 1  1/96 (1.04%)  1 2/95 (2.11%)  2 0/94 (0.00%)  0
Pyrexia * 1  4/96 (4.17%)  4 3/95 (3.16%)  3 1/94 (1.06%)  1
Infections and infestations       
Folliculitis * 1  1/96 (1.04%)  1 7/95 (7.37%)  7 2/94 (2.13%)  2
Gastroenteritis * 1  1/96 (1.04%)  1 2/95 (2.11%)  2 2/94 (2.13%)  2
Hordeolum * 1  0/96 (0.00%)  0 2/95 (2.11%)  2 0/94 (0.00%)  0
Influenza * 1  1/96 (1.04%)  1 4/95 (4.21%)  4 2/94 (2.13%)  2
Nasopharyngitis * 1  9/96 (9.38%)  11 8/95 (8.42%)  10 8/94 (8.51%)  9
Oral herpes * 1  0/96 (0.00%)  0 1/95 (1.05%)  2 2/94 (2.13%)  2
Pharyngitis * 1  3/96 (3.13%)  3 5/95 (5.26%)  5 3/94 (3.19%)  3
Pharyngitis streptococcal * 1  2/96 (2.08%)  2 0/95 (0.00%)  0 0/94 (0.00%)  0
Sinusitis * 1  0/96 (0.00%)  0 0/95 (0.00%)  0 3/94 (3.19%)  3
Upper respiratory tract infection * 1  10/96 (10.42%)  12 9/95 (9.47%)  11 10/94 (10.64%)  14
Injury, poisoning and procedural complications       
Contusion * 1  0/96 (0.00%)  0 2/95 (2.11%)  2 0/94 (0.00%)  0
Investigations       
Blood creatine phosphokinase increased * 1  0/96 (0.00%)  0 4/95 (4.21%)  5 4/94 (4.26%)  4
Blood lactate dehydrogenase increased * 1  0/96 (0.00%)  0 1/95 (1.05%)  1 2/94 (2.13%)  2
Blood uric acid increased * 1  2/96 (2.08%)  2 1/95 (1.05%)  1 0/94 (0.00%)  0
Haemoglobin decreased * 1  0/96 (0.00%)  0 0/95 (0.00%)  0 2/94 (2.13%)  3
Protein urine * 1  2/96 (2.08%)  2 1/95 (1.05%)  1 0/94 (0.00%)  0
Nervous system disorders       
Dizziness * 1  1/96 (1.04%)  2 0/95 (0.00%)  0 6/94 (6.38%)  9
Headache * 1  7/96 (7.29%)  8 5/95 (5.26%)  7 8/94 (8.51%)  12
Somnolence * 1  2/96 (2.08%)  2 0/95 (0.00%)  0 2/94 (2.13%)  2
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  2/96 (2.08%)  2 1/95 (1.05%)  1 1/94 (1.06%)  3
Cough * 1  2/96 (2.08%)  2 4/95 (4.21%)  6 1/94 (1.06%)  1
Rhinorrhoea * 1  3/96 (3.13%)  4 1/95 (1.05%)  1 0/94 (0.00%)  0
Skin and subcutaneous tissue disorders       
Acne * 1  1/96 (1.04%)  2 3/95 (3.16%)  3 5/94 (5.32%)  5
Dermatitis atopic * 1  2/96 (2.08%)  2 2/95 (2.11%)  2 1/94 (1.06%)  2
1
Term from vocabulary, MedDRA v23.0
*
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):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03796676    
Other Study ID Numbers: B7451036
JADE TEEN ( Other Identifier: Alias Study Number )
2018-003804-37 ( EudraCT Number )
First Submitted: January 4, 2019
First Posted: January 8, 2019
Results First Submitted: March 18, 2021
Results First Posted: June 4, 2021
Last Update Posted: April 13, 2022