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Trial record 19 of 23 for:    PF-04965842

Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

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: NCT02780167
Recruitment Status : Completed
First Posted : May 23, 2016
Results First Posted : May 16, 2018
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: PF-04965842
Drug: Placebo
Enrollment 269
Recruitment Details  
Pre-assignment Details A total of 269 participants were randomized. There were 2 participants who were randomized but did not receive any study treatment. All other participants were treated.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description Participants received matching placebo tablets for a 12-week double-blind treatment period. Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period. Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Period Title: Overall Study
Started 56 49 51 56 55
Completed 28 27 27 37 38
Not Completed 28 22 24 19 17
Reason Not Completed
Adverse Event             9             8             8             12             8
Lack of Efficacy             6             5             6             1             0
Lost to Follow-up             2             0             1             0             0
Does not meet entrance criteria             0             0             1             0             0
No longer meets eligibility criteria             0             0             0             1             1
Protocol Violation             5             5             1             1             2
Withdrawal by Subject             6             4             4             3             4
Other             0             0             3             1             2
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD Total
Hide Arm/Group Description Participants received matching placebo tablets for a 12-week double-blind treatment period. Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period. Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period. Total of all reporting groups
Overall Number of Baseline Participants 56 49 51 56 55 267
Hide Baseline Analysis Population Description
The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 49 participants 51 participants 56 participants 55 participants 267 participants
42.6  (15.1) 44.3  (15.9) 37.6  (15.9) 41.1  (15.6) 38.7  (17.6) 40.8  (16.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 49 participants 51 participants 56 participants 55 participants 267 participants
Female
35
  62.5%
28
  57.1%
29
  56.9%
25
  44.6%
27
  49.1%
144
  53.9%
Male
21
  37.5%
21
  42.9%
22
  43.1%
31
  55.4%
28
  50.9%
123
  46.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 49 participants 51 participants 56 participants 55 participants 267 participants
White
40
  71.4%
38
  77.6%
39
  76.5%
40
  71.4%
37
  67.3%
194
  72.7%
Black
10
  17.9%
5
  10.2%
4
   7.8%
7
  12.5%
13
  23.6%
39
  14.6%
Asian
4
   7.1%
5
  10.2%
5
   9.8%
8
  14.3%
5
   9.1%
27
  10.1%
Other
2
   3.6%
1
   2.0%
3
   5.9%
1
   1.8%
0
   0.0%
7
   2.6%
1.Primary Outcome
Title Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12
Hide Description The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the full analysis set (FAS) population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Least Squares Mean (Standard Error)
Unit of Measure: percentage of participants
6.3  (2.55) 8.2  (2.32) 12.3  (2.88) 27.8  (5.07) 44.5  (6.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 10mg QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1210
Comments [Not Specified]
Method Emax model
Comments Emax model with non-responder imputation (NRI)
Method of Estimation Estimation Parameter Estimate difference
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
-0.7 to 4.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.99
Estimation Comments Test group: PF-04965842 10 mg QD, Reference group: Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 30mg QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1065
Comments [Not Specified]
Method Emax model
Comments Emax model with non-responder imputation (NRI)
Method of Estimation Estimation Parameter Estimate difference
Estimated Value 6.0
Confidence Interval (2-Sided) 95%
-1.8 to 13.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.05
Estimation Comments Test group: PF-04965842 30 mg QD, Reference group: Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 100mg QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0184
Comments [Not Specified]
Method Emax model
Comments Emax model with non-responder imputation (NRI)
Method of Estimation Estimation Parameter Estimate difference
Estimated Value 21.5
Confidence Interval (2-Sided) 95%
5.5 to 37.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.25
Estimation Comments Test group: PF-04965842 100 mg QD, Reference group: Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200mg QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments [Not Specified]
Method Emax model
Comments Emax model with non-responder imputation (NRI)
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 38.2
Confidence Interval (2-Sided) 95%
19.7 to 56.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.18
Estimation Comments Test group: PF-04965842 200 mg QD, Reference group: Placebo.
2.Secondary Outcome
Title Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12
Hide Description The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the full analysis set (FAS) population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-35.22  (6.572) -31.13  (7.090) -40.73  (6.823) -59.04  (6.212) -82.57  (6.161)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 10mg QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6731
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed-effects model repeated measures (MMRM) with observed cases (OC)
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.08
Confidence Interval (2-Sided) 90%
-11.88 to 20.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.667
Estimation Comments Test group: PF-04965842 10 mg QD, Reference group: Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 30mg QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5610
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM with OC
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.52
Confidence Interval (2-Sided) 90%
-21.16 to 10.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.474
Estimation Comments Test group: PF-04965842 30 mg QD, Reference group: Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 100mg QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0091
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM with OC
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -23.82
Confidence Interval (2-Sided) 90%
-38.76 to -8.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.043
Estimation Comments Test group: PF-04965842 100 mg QD, Reference group: Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-04965842 200mg QD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments MMRM with OC
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -47.35
Confidence Interval (2-Sided) 90%
-62.23 to -32.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.008
Estimation Comments Test group: PF-04965842 200 mg QD, Reference group: Placebo.
3.Secondary Outcome
Title Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
Hide Description The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Time Frame Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16.
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the full analysis set (FAS) population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 54 participants 48 participants 50 participants 55 participants 54 participants
0.0 2.1 2.0 1.8 3.7
Week 2 Number Analyzed 55 participants 49 participants 50 participants 55 participants 52 participants
3.6 6.1 6.0 3.6 11.5
Week 4 Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
1.8 8.2 8.0 16.4 40.7
Week 6 Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
14.5 14.3 14.0 12.7 40.7
Week 8 Number Analyzed 55 participants 49 participants 50 participants 55 participants 53 participants
5.5 8.2 12.0 16.4 41.5
Week 13 Number Analyzed 30 participants 29 participants 31 participants 38 participants 45 participants
10.0 20.7 12.9 23.7 26.7
Week 14 Number Analyzed 32 participants 28 participants 29 participants 40 participants 44 participants
18.8 10.7 3.4 12.5 15.9
Week 16 Number Analyzed 28 participants 26 participants 27 participants 36 participants 38 participants
10.7 23.1 7.4 13.9 18.4
4.Secondary Outcome
Title Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points
Hide Description The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
Time Frame Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 54 participants 48 participants 49 participants 55 participants 53 participants
1.9 4.2 6.1 5.5 9.4
Week 2 Number Analyzed 55 participants 48 participants 47 participants 53 participants 50 participants
7.3 10.4 10.6 11.3 24.0
Week 4 Number Analyzed 50 participants 45 participants 47 participants 52 participants 52 participants
8.0 11.1 12.8 25.0 51.9
Week 6 Number Analyzed 44 participants 38 participants 43 participants 48 participants 52 participants
22.7 23.7 18.6 29.2 59.6
Week 8 Number Analyzed 41 participants 36 participants 43 participants 47 participants 49 participants
14.6 19.4 23.3 34.0 59.2
Week 12 Number Analyzed 35 participants 29 participants 30 participants 43 participants 42 participants
17.1 17.2 23.3 51.2 57.1
Week 13 Number Analyzed 30 participants 29 participants 31 participants 38 participants 45 participants
13.3 24.1 12.9 26.3 37.8
Week 14 Number Analyzed 32 participants 28 participants 29 participants 40 participants 44 participants
21.9 17.9 10.3 20.0 25.0
Week 16 Number Analyzed 28 participants 26 participants 27 participants 36 participants 38 participants
14.3 26.9 11.1 22.2 31.6
5.Secondary Outcome
Title Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.
Hide Description The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The 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.
Time Frame Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 1 Number Analyzed 54 participants 48 participants 49 participants 55 participants 53 participants
-12.28  (27.205) -13.80  (26.526) -14.85  (33.721) -19.85  (30.379) -41.26  (32.064)
Week 2 Number Analyzed 55 participants 48 participants 47 participants 53 participants 50 participants
-23.54  (33.348) -14.79  (40.474) -26.29  (33.298) -38.26  (39.176) -63.28  (25.754)
Week 4 Number Analyzed 50 participants 45 participants 47 participants 52 participants 52 participants
-24.58  (40.520) -30.06  (40.852) -32.81  (40.255) -53.59  (35.274) -78.16  (20.666)
Week 6 Number Analyzed 44 participants 38 participants 43 participants 48 participants 52 participants
-39.17  (39.299) -35.18  (43.498) -40.16  (43.849) -54.16  (53.212) -83.14  (17.267)
Week 8 Number Analyzed 41 participants 36 participants 43 participants 47 participants 49 participants
-36.69  (42.629) -39.43  (46.270) -36.83  (52.632) -53.96  (53.689) -84.48  (16.226)
Week 13 Number Analyzed 30 participants 29 participants 31 participants 38 participants 45 participants
-29.82  (50.404) -34.11  (51.089) -32.97  (45.223) -51.23  (45.968) -66.34  (34.951)
Week 14 Number Analyzed 32 participants 28 participants 29 participants 40 participants 44 participants
-35.51  (43.357) -31.54  (62.829) -26.25  (49.184) -38.80  (49.085) -57.15  (36.739)
Week 16 Number Analyzed 28 participants 26 participants 27 participants 36 participants 38 participants
-35.91  (47.713) -45.24  (44.576) -20.80  (47.915) -27.66  (54.570) -55.82  (32.833)
6.Secondary Outcome
Title Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points
Hide Description

The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).

The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10).

Time Frame Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Measure Type: Number
Unit of Measure: percentage of participants
Itching due to AD Day 2 Number Analyzed 50 participants 45 participants 47 participants 54 participants 53 participants
4.0 6.7 17.0 14.8 17.0
Itching due to AD Day 3 Number Analyzed 50 participants 45 participants 47 participants 54 participants 53 participants
8.0 2.2 14.9 22.2 28.3
Itching due to AD Day 4 Number Analyzed 50 participants 45 participants 47 participants 54 participants 52 participants
2.0 2.2 21.3 22.2 34.6
Itching due to AD Day 5 Number Analyzed 50 participants 45 participants 47 participants 54 participants 52 participants
2.0 6.7 29.8 24.1 36.5
Itching due to AD Day 6 Number Analyzed 50 participants 45 participants 47 participants 54 participants 52 participants
10.0 8.9 25.5 24.1 40.4
Itching due to AD Day 7 Number Analyzed 51 participants 45 participants 47 participants 53 participants 52 participants
11.8 13.3 25.5 30.2 42.3
Itching due to AD Day 8 Number Analyzed 50 participants 45 participants 48 participants 55 participants 51 participants
10.0 13.3 25.0 43.6 51.0
Itching due to AD Day 9 Number Analyzed 48 participants 45 participants 46 participants 55 participants 52 participants
8.3 11.1 26.1 45.5 50.0
Itching due to AD Day 10 Number Analyzed 49 participants 45 participants 47 participants 55 participants 52 participants
8.2 11.1 34.0 43.6 55.8
Itching due to AD Day 11 Number Analyzed 50 participants 45 participants 47 participants 55 participants 52 participants
16.0 15.6 27.7 43.6 57.7
Itching due to AD Day 12 Number Analyzed 50 participants 45 participants 47 participants 55 participants 51 participants
22.0 17.8 38.3 49.1 60.8
Itching due to AD Day 13 Number Analyzed 50 participants 45 participants 46 participants 52 participants 50 participants
24.0 15.6 28.3 53.8 66.0
Itching due to AD Day 14 Number Analyzed 49 participants 42 participants 45 participants 52 participants 49 participants
22.4 19.0 26.7 48.1 67.3
Itching due to AD Day 15 Number Analyzed 40 participants 39 participants 39 participants 44 participants 40 participants
25.0 17.9 30.8 54.5 72.5
Itching due to AD Day 29 Number Analyzed 52 participants 45 participants 45 participants 55 participants 51 participants
32.7 31.1 37.8 60.0 74.5
Itching due to AD Day 43 Number Analyzed 51 participants 48 participants 47 participants 54 participants 52 participants
31.4 35.4 38.3 53.7 73.1
Itching due to AD Day 57 Number Analyzed 52 participants 47 participants 47 participants 55 participants 50 participants
28.8 31.9 38.3 54.5 72.0
Itching due to AD Day 85 Number Analyzed 52 participants 47 participants 46 participants 54 participants 50 participants
26.9 21.3 41.3 53.7 64.0
Itching due to AD Day 99 Number Analyzed 30 participants 27 participants 27 participants 40 participants 41 participants
33.3 25.9 33.3 47.5 41.5
Itching due to AD Day 113 Number Analyzed 23 participants 24 participants 25 participants 36 participants 34 participants
52.2 29.2 24.0 44.4 35.3
Frequency of itching due to AD Day 2 Number Analyzed 50 participants 45 participants 47 participants 54 participants 53 participants
6.0 8.9 19.1 22.2 26.4
Frequency of itching due to AD Day 3 Number Analyzed 50 participants 45 participants 47 participants 54 participants 53 participants
10.0 8.9 19.1 25.9 34.0
Frequency of itching due to AD Day 4 Number Analyzed 50 participants 45 participants 47 participants 54 participants 52 participants
8.0 4.4 23.4 25.9 48.1
Frequency of itching due to AD Day 5 Number Analyzed 50 participants 45 participants 47 participants 54 participants 52 participants
10.0 6.7 31.9 29.6 46.2
Frequency of itching due to AD Day 6 Number Analyzed 50 participants 45 participants 47 participants 54 participants 52 participants
14.0 8.9 27.7 33.3 57.7
Frequency of itching due to AD Day 7 Number Analyzed 51 participants 45 participants 47 participants 53 participants 52 participants
15.7 11.1 31.9 34.0 55.8
Frequency of itching due to AD Day 8 Number Analyzed 50 participants 45 participants 48 participants 55 participants 51 participants
16.0 11.1 29.2 45.5 60.8
Frequency of itching due to AD Day 9 Number Analyzed 48 participants 45 participants 46 participants 55 participants 52 participants
14.6 13.3 30.4 45.5 55.8
Frequency of itching due to AD Day 10 Number Analyzed 49 participants 45 participants 47 participants 55 participants 52 participants
14.3 13.3 36.2 45.5 65.4
Frequency of itching due to AD Day 11 Number Analyzed 50 participants 45 participants 47 participants 55 participants 52 participants
20.0 15.6 36.2 45.5 63.5
Frequency of itching due to AD Day 12 Number Analyzed 50 participants 45 participants 47 participants 55 participants 51 participants
18.0 17.8 38.3 50.9 60.8
Frequency of itching due to AD Day 13 Number Analyzed 50 participants 45 participants 46 participants 52 participants 50 participants
20.0 20.0 30.4 51.9 70.0
Frequency of itching due to AD Day 14 Number Analyzed 49 participants 42 participants 45 participants 52 participants 49 participants
24.5 23.8 33.3 48.1 71.4
Frequency of itching due to AD Day 15 Number Analyzed 40 participants 39 participants 39 participants 44 participants 40 participants
30.0 20.5 38.5 52.3 72.5
Frequency of itching due to AD Day 29 Number Analyzed 52 participants 45 participants 45 participants 55 participants 51 participants
28.8 28.9 40.0 60.0 74.5
Frequency of itching due to AD Day 43 Number Analyzed 51 participants 48 participants 47 participants 54 participants 52 participants
23.5 35.4 38.3 57.4 75.0
Frequency of itching due to AD Day 57 Number Analyzed 52 participants 47 participants 47 participants 55 participants 50 participants
26.9 29.8 38.3 54.5 74.0
Frequency of itching due to AD Day 85 Number Analyzed 52 participants 47 participants 46 participants 54 participants 50 participants
25.0 25.5 34.8 53.7 70.0
Frequency of itching due to AD Day 99 Number Analyzed 30 participants 27 participants 27 participants 40 participants 41 participants
30.0 22.2 37.0 47.5 39.0
Frequency of itching due to AD Day 113 Number Analyzed 23 participants 24 participants 25 participants 36 participants 34 participants
47.8 25.0 20.0 47.2 38.2
7.Secondary Outcome
Title Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points
Hide Description

The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).

The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10).

Time Frame Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Measure Type: Number
Unit of Measure: percentage of participants
Itching due to AD Day 2 Number Analyzed 49 participants 45 participants 46 participants 50 participants 46 participants
2.0 2.2 6.5 10.0 15.2
Itching due to AD Day 3 Number Analyzed 49 participants 45 participants 46 participants 50 participants 46 participants
0.0 2.2 13.0 14.0 21.7
Itching due to AD Day 4 Number Analyzed 49 participants 45 participants 46 participants 50 participants 45 participants
0.0 0.0 17.4 14.0 28.9
Itching due to AD Day 5 Number Analyzed 49 participants 45 participants 46 participants 50 participants 45 participants
2.0 2.2 19.6 20.0 26.7
Itching due to AD Day 6 Number Analyzed 49 participants 45 participants 46 participants 50 participants 45 participants
6.1 2.2 17.4 24.0 35.6
Itching due to AD Day 7 Number Analyzed 50 participants 45 participants 46 participants 49 participants 45 participants
8.0 8.9 19.6 20.4 37.8
Itching due to AD Day 8 Number Analyzed 49 participants 45 participants 47 participants 51 participants 44 participants
6.1 4.4 14.9 29.4 52.3
Itching due to AD Day 9 Number Analyzed 47 participants 45 participants 45 participants 51 participants 45 participants
2.1 6.7 20.0 27.5 51.1
Itching due to AD Day 10 Number Analyzed 48 participants 45 participants 46 participants 51 participants 45 participants
4.2 6.7 21.7 29.4 44.4
Itching due to AD Day 11 Number Analyzed 49 participants 45 participants 46 participants 51 participants 45 participants
8.2 13.3 19.6 29.4 44.4
Itching due to AD Day 12 Number Analyzed 49 participants 45 participants 46 participants 51 participants 45 participants
10.2 11.1 23.9 35.3 51.1
Itching due to AD Day 13 Number Analyzed 49 participants 45 participants 45 participants 49 participants 44 participants
14.3 6.7 20.0 38.8 61.4
Itching due to AD Day 14 Number Analyzed 48 participants 42 participants 44 participants 48 participants 44 participants
10.4 14.3 25.0 41.7 59.1
Itching due to AD Day 15 Number Analyzed 40 participants 38 participants 38 participants 43 participants 37 participants
15.0 7.9 31.6 41.9 70.3
Itching due to AD Day 29 Number Analyzed 51 participants 44 participants 44 participants 51 participants 45 participants
17.6 13.6 25.0 52.9 68.9
Itching due to AD Day 43 Number Analyzed 50 participants 45 participants 46 participants 50 participants 46 participants
20.0 22.2 23.9 50.0 71.7
Itching due to AD Day 57 Number Analyzed 51 participants 44 participants 46 participants 51 participants 44 participants
17.6 22.7 26.1 52.9 72.7
Itching due to AD Day 85 Number Analyzed 51 participants 44 participants 45 participants 50 participants 44 participants
25.5 22.7 33.3 50.0 63.6
Itching due to AD Day 99 Number Analyzed 29 participants 27 participants 26 participants 39 participants 35 participants
27.6 25.9 23.1 38.5 37.1
Itching due to AD Day 113 Number Analyzed 23 participants 24 participants 24 participants 35 participants 29 participants
43.5 20.8 16.7 34.3 31.0
Frequency of itching due to AD Day 2 Number Analyzed 47 participants 45 participants 42 participants 52 participants 48 participants
2.1 0.0 7.1 11.5 18.8
Frequency of itching due to AD Day 3 Number Analyzed 47 participants 45 participants 42 participants 52 participants 48 participants
6.4 2.2 11.9 13.5 22.9
Frequency of itching due to AD Day 4 Number Analyzed 47 participants 45 participants 42 participants 52 participants 47 participants
2.1 0.0 19.0 21.2 36.2
Frequency of itching due to AD Day 5 Number Analyzed 47 participants 45 participants 42 participants 52 participants 47 participants
4.3 4.4 23.8 25.0 38.3
Frequency of itching due to AD Day 6 Number Analyzed 47 participants 45 participants 42 participants 52 participants 47 participants
10.6 6.7 26.2 25.0 44.7
Frequency of itching due to AD Day 7 Number Analyzed 48 participants 45 participants 42 participants 50 participants 47 participants
10.4 4.4 19.0 30.0 51.1
Frequency of itching due to AD Day 8 Number Analyzed 47 participants 45 participants 43 participants 52 participants 46 participants
8.5 2.2 23.3 36.5 54.3
Frequency of itching due to AD Day 9 Number Analyzed 45 participants 45 participants 41 participants 52 participants 47 participants
6.7 6.7 26.8 36.5 48.9
Frequency of itching due to AD Day 10 Number Analyzed 46 participants 45 participants 42 participants 52 participants 47 participants
6.5 8.9 31.0 28.8 51.1
Frequency of itching due to AD Day 11 Number Analyzed 47 participants 45 participants 42 participants 52 participants 47 participants
10.6 15.6 23.8 32.7 55.3
Frequency of itching due to AD Day 12 Number Analyzed 47 participants 45 participants 42 participants 52 participants 46 participants
12.8 13.3 26.2 34.6 54.3
Frequency of itching due to AD Day 13 Number Analyzed 47 participants 45 participants 41 participants 50 participants 45 participants
17.0 15.6 29.3 32.0 66.7
Frequency of itching due to AD Day 14 Number Analyzed 46 participants 42 participants 40 participants 49 participants 45 participants
19.6 16.7 30.0 34.7 66.7
Frequency of itching due to AD Day 15 Number Analyzed 40 participants 38 participants 34 participants 44 participants 38 participants
20.0 15.8 35.3 36.4 71.1
Frequency of itching due to AD Day 29 Number Analyzed 49 participants 44 participants 40 participants 52 participants 47 participants
16.3 15.9 35.0 51.9 66.0
Frequency of itching due to AD Day 43 Number Analyzed 48 participants 45 participants 42 participants 51 participants 48 participants
12.5 24.4 28.6 58.8 72.9
Frequency of itching due to AD Day 57 Number Analyzed 49 participants 44 participants 42 participants 52 participants 46 participants
16.3 20.5 33.3 53.8 73.9
Frequency of itching due to AD Day 85 Number Analyzed 49 participants 44 participants 42 participants 51 participants 46 participants
24.5 25.0 28.6 47.1 69.6
Frequency of itching due to AD Day 99 Number Analyzed 29 participants 27 participants 24 participants 38 participants 37 participants
20.7 18.5 16.7 39.5 32.4
Frequency of itching due to AD Day 113 Number Analyzed 23 participants 24 participants 22 participants 34 participants 30 participants
34.8 20.8 22.7 29.4 26.7
8.Secondary Outcome
Title Time to Achieving >=3 Points Improvement in NRS
Hide Description

The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).

The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10).

Time Frame Baseline till Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Median (90% Confidence Interval)
Unit of Measure: day
Itching due to AD Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
30.0
(15.0 to 56.0)
43.0
(29.0 to 57.0)
12.0
(8.0 to 30.0)
9.0
(7.0 to 14.0)
7.0
(5.0 to 11.0)
Frequency of itching due to AD Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
29.0
(13.0 to 57.0)
43.0
(29.0 to 85.0)
13.0
(7.0 to 43.0)
8.0
(4.0 to 10.0)
4.0
(4.0 to 6.0)
9.Secondary Outcome
Title Time to Achieving >=4 Points Improvement in NRS
Hide Description

The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).

The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10).

Time Frame Baseline till Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Median (90% Confidence Interval)
Unit of Measure: day
Itching due to atopic dermatitis Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
78.0 [1] 
(56.0 to NA)
NA [2] 
(47.0 to NA)
43.0
(15.0 to 85.0)
14.0
(10.0 to 29.0)
10.0
(7.0 to 13.0)
Frequency of itching due to atopic dermatitis Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
59.0 [1] 
(30.0 to NA)
NA [2] 
(56.0 to NA)
29.0
(12.0 to 98.0)
14.0
(8.0 to 29.0)
7.0
(5.0 to 9.0)
[1]
The NA was generated because of the high censoring rates in the placebo group.
[2]
The NA was generated because of the high censoring rates in the PF-04965842 10 mg group.
10.Secondary Outcome
Title Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points
Hide Description

The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).

The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10).

Time Frame Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Mean (Standard Deviation)
Unit of Measure: percent change
Itching due to AD Day 2 Number Analyzed 50 participants 45 participants 47 participants 53 participants 51 participants
0.56  (19.298) -1.51  (19.857) -9.39  (23.528) -10.06  (25.930) -6.79  (47.751)
Itching due to AD Day 3 Number Analyzed 50 participants 45 participants 47 participants 52 participants 51 participants
-1.32  (22.630) 2.48  (21.994) -8.22  (33.257) -15.32  (27.874) -16.72  (40.055)
Itching due to AD Day 4 Number Analyzed 50 participants 44 participants 47 participants 52 participants 50 participants
-1.98  (22.326) 0.23  (17.314) -12.18  (33.385) -17.62  (25.747) -25.80  (38.557)
Itching due to AD Day 5 Number Analyzed 50 participants 44 participants 47 participants 52 participants 50 participants
-2.98  (22.385) -2.37  (20.174) -18.92  (31.846) -20.48  (27.983) -30.91  (34.215)
Itching due to AD Day 6 Number Analyzed 50 participants 44 participants 47 participants 52 participants 50 participants
-1.52  (25.690) -5.70  (23.478) -16.70  (33.407) -21.58  (27.842) -34.02  (35.532)
Itching due to AD Day 7 Number Analyzed 51 participants 44 participants 47 participants 51 participants 50 participants
-4.18  (30.531) -4.59  (28.248) -18.07  (33.640) -23.02  (33.524) -38.17  (35.428)
Itching due to AD Day 8 Number Analyzed 50 participants 44 participants 46 participants 53 participants 49 participants
-0.35  (34.144) -5.69  (25.576) -17.87  (34.789) -32.36  (30.610) -43.13  (38.684)
Itching due to AD Day 9 Number Analyzed 48 participants 44 participants 42 participants 51 participants 49 participants
-2.56  (30.688) -8.61  (27.803) -22.74  (33.667) -31.82  (30.951) -39.37  (41.055)
Itching due to AD Day 10 Number Analyzed 49 participants 44 participants 43 participants 51 participants 49 participants
-3.32  (29.885) -5.97  (29.093) -22.90  (41.573) -31.93  (27.094) -39.60  (56.607)
Itching due to AD Day 11 Number Analyzed 49 participants 44 participants 43 participants 51 participants 49 participants
-7.81  (30.201) -5.94  (31.028) -16.76  (49.412) -33.13  (27.902) -42.50  (51.621)
Itching due to AD Day 12 Number Analyzed 49 participants 44 participants 43 participants 51 participants 48 participants
-11.12  (30.087) -6.65  (32.617) -27.84  (33.416) -33.30  (34.252) -46.40  (46.241)
Itching due to AD Day 13 Number Analyzed 48 participants 44 participants 42 participants 49 participants 47 participants
-15.16  (29.759) -7.43  (27.374) -24.56  (30.086) -35.89  (35.651) -49.77  (48.426)
Itching due to AD Day 14 Number Analyzed 47 participants 41 participants 41 participants 48 participants 46 participants
-13.61  (30.153) -8.84  (29.474) -26.70  (29.805) -36.57  (27.552) -55.45  (34.331)
Itching due to AD Day 15 Number Analyzed 38 participants 35 participants 35 participants 42 participants 38 participants
-17.24  (30.755) -7.28  (28.058) -25.09  (37.815) -35.41  (29.140) -59.00  (39.804)
Itching due to AD Day 29 Number Analyzed 46 participants 41 participants 41 participants 51 participants 49 participants
-19.43  (35.575) -16.63  (34.554) -28.41  (36.183) -46.62  (40.090) -68.09  (31.214)
Itching due to AD Day 43 Number Analyzed 40 participants 37 participants 40 participants 46 participants 50 participants
-26.55  (36.418) -27.15  (39.550) -31.14  (39.090) -49.49  (46.279) -67.80  (36.372)
Itching due to AD Day 57 Number Analyzed 38 participants 34 participants 40 participants 46 participants 46 participants
-25.54  (39.577) -21.60  (44.446) -29.60  (39.606) -54.11  (36.374) -70.13  (36.338)
Itching due to AD Day 85 Number Analyzed 35 participants 30 participants 31 participants 42 participants 44 participants
-30.10  (42.697) -22.47  (48.291) -30.39  (47.772) -56.51  (41.955) -53.66  (109.454)
Itching due to AD Day 99 Number Analyzed 30 participants 27 participants 27 participants 39 participants 41 participants
-19.24  (43.251) -15.94  (42.332) -11.46  (39.959) -32.68  (34.789) 5.61  (139.223)
Itching due to AD Day 113 Number Analyzed 23 participants 24 participants 25 participants 35 participants 34 participants
-31.99  (45.929) -14.07  (47.186) -14.34  (29.756) -28.47  (41.027) 24.61  (190.848)
Frequency of itching due to AD Day 2 Number Analyzed 50 participants 45 participants 47 participants 53 participants 52 participants
6.72  (45.759) -6.67  (19.016) -10.14  (28.184) -17.93  (20.967) -10.52  (79.180)
Frequency of itching due to AD Day 3 Number Analyzed 50 participants 45 participants 47 participants 52 participants 52 participants
2.59  (45.541) 0.30  (24.330) -3.96  (49.425) -19.98  (22.910) -16.46  (67.794)
Frequency of itching due to AD Day 4 Number Analyzed 50 participants 44 participants 47 participants 52 participants 51 participants
3.73  (37.683) -3.25  (15.230) -9.39  (39.225) -20.71  (24.391) -28.27  (47.925)
Frequency of itching due to AD Day 5 Number Analyzed 50 participants 44 participants 47 participants 52 participants 51 participants
-0.70  (34.834) -3.73  (23.125) -17.72  (38.967) -23.69  (24.954) -35.45  (37.436)
Frequency of itching due to AD Day 6 Number Analyzed 50 participants 44 participants 47 participants 52 participants 51 participants
4.04  (52.799) -5.76  (24.623) -14.84  (38.256) -26.47  (27.218) -44.31  (36.476)
Frequency of itching due to AD Day 7 Number Analyzed 51 participants 44 participants 47 participants 51 participants 51 participants
-2.25  (37.193) -3.56  (25.414) -17.05  (40.108) -27.80  (32.466) -40.19  (39.702)
Frequency of itching due to AD Day 8 Number Analyzed 50 participants 44 participants 46 participants 53 participants 50 participants
1.22  (38.544) -3.90  (25.515) -19.05  (36.488) -35.44  (29.791) -46.26  (43.491)
Frequency of itching due to AD Day 9 Number Analyzed 48 participants 44 participants 42 participants 51 participants 50 participants
1.08  (58.633) -8.79  (26.589) -17.58  (42.054) -35.17  (29.637) -44.29  (43.238)
Frequency of itching due to AD Day 10 Number Analyzed 49 participants 44 participants 43 participants 51 participants 50 participants
-3.47  (53.518) -5.41  (32.491) -19.84  (47.884) -33.23  (26.950) -49.78  (37.349)
Frequency of itching due to AD Day 11 Number Analyzed 49 participants 44 participants 43 participants 51 participants 50 participants
-6.24  (49.163) -5.88  (32.750) -18.73  (42.599) -34.93  (27.181) -51.62  (37.385)
Frequency of itching due to AD Day 12 Number Analyzed 49 participants 44 participants 43 participants 51 participants 49 participants
-8.41  (49.918) -5.65  (36.637) -25.00  (31.695) -36.55  (27.281) -51.92  (40.010)
Frequency of itching due to AD Day 13 Number Analyzed 48 participants 44 participants 42 participants 49 participants 48 participants
-13.45  (40.159) -10.46  (31.103) -24.73  (31.960) -35.75  (32.757) -53.17  (40.695)
Frequency of itching due to AD Day 14 Number Analyzed 47 participants 41 participants 41 participants 48 participants 47 participants
-10.26  (46.126) -13.86  (32.390) -27.70  (30.476) -38.28  (27.724) -57.50  (39.073)
Frequency of itching due to AD Day 15 Number Analyzed 38 participants 35 participants 35 participants 42 participants 38 participants
-18.78  (34.923) -11.34  (28.494) -26.88  (38.846) -38.87  (29.184) -60.99  (32.840)
Frequency of itching due to AD Day 29 Number Analyzed 46 participants 41 participants 41 participants 51 participants 49 participants
-16.05  (39.630) -17.15  (33.432) -28.55  (43.421) -49.94  (36.649) -67.84  (29.918)
Frequency of itching due to AD Day 43 Number Analyzed 40 participants 37 participants 40 participants 46 participants 50 participants
-24.51  (30.798) -32.19  (37.806) -26.48  (46.793) -53.95  (41.772) -69.24  (38.370)
Frequency of itching due to AD Day 57 Number Analyzed 38 participants 34 participants 40 participants 46 participants 46 participants
-24.94  (35.662) -23.28  (44.257) -27.91  (39.142) -55.39  (35.447) -73.50  (30.583)
Frequency of itching due to AD Day 85 Number Analyzed 35 participants 30 participants 31 participants 42 participants 44 participants
-29.81  (44.035) -25.76  (43.273) -32.28  (38.817) -54.51  (43.354) -54.54  (120.723)
Frequency of itching due to AD Day 99 Number Analyzed 30 participants 27 participants 27 participants 39 participants 41 participants
-17.46  (43.552) -20.21  (36.947) -3.36  (52.153) -13.57  (123.800) 2.12  (144.572)
Frequency of itching due to AD Day 113 Number Analyzed 23 participants 24 participants 25 participants 35 participants 34 participants
-28.95  (46.896) -16.22  (38.055) -5.65  (51.132) -12.62  (113.423) 27.77  (203.937)
11.Secondary Outcome
Title Change From Baseline in Pruritus NRS Score at All Scheduled Time Points
Hide Description

The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).

The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10).

Time Frame Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
Itching due to AD Day 2 Number Analyzed 50 participants 45 participants 47 participants 54 participants 52 participants
-0.08  (1.307) -0.20  (1.217) -0.83  (1.672) -0.85  (1.607) -1.00  (2.433)
Itching due to AD Day 3 Number Analyzed 50 participants 45 participants 47 participants 53 participants 52 participants
-0.22  (1.418) 0.02  (1.357) -0.85  (2.095) -1.21  (1.702) -1.48  (2.493)
Itching due to AD Day 4 Number Analyzed 50 participants 44 participants 47 participants 53 participants 51 participants
-0.22  (1.389) -0.09  (1.117) -1.09  (2.263) -1.26  (1.862) -2.12  (2.590)
Itching due to AD Day 5 Number Analyzed 50 participants 44 participants 47 participants 53 participants 51 participants
-0.32  (1.406) -0.27  (1.264) -1.55  (2.348) -1.58  (1.865) -2.35  (2.583)
Itching due to AD Day 6 Number Analyzed 50 participants 44 participants 47 participants 53 participants 51 participants
-0.28  (1.727) -0.55  (1.405) -1.47  (2.492) -1.49  (2.317) -2.53  (2.648)
Itching due to AD Day 7 Number Analyzed 51 participants 44 participants 47 participants 52 participants 51 participants
-0.53  (2.023) -0.52  (1.745) -1.51  (2.422) -1.75  (2.159) -2.77  (2.795)
Itching due to AD Day 8 Number Analyzed 50 participants 44 participants 46 participants 54 participants 50 participants
-0.30  (2.215) -0.56  (1.560) -1.65  (2.514) -2.39  (2.294) -3.22  (3.039)
Itching due to AD Day 9 Number Analyzed 48 participants 44 participants 42 participants 52 participants 50 participants
-0.38  (2.080) -0.75  (1.844) -1.95  (2.527) -2.40  (2.154) -3.18  (2.988)
Itching due to AD Day 10 Number Analyzed 49 participants 44 participants 43 participants 52 participants 50 participants
-0.43  (1.947) -0.61  (1.967) -2.09  (2.698) -2.21  (2.412) -3.38  (2.975)
Itching due to AD Day 11 Number Analyzed 49 participants 44 participants 43 participants 52 participants 50 participants
-0.73  (1.955) -0.61  (2.148) -1.72  (2.462) -2.33  (2.415) -3.40  (3.071)
Itching due to AD Day 12 Number Analyzed 49 participants 44 participants 43 participants 52 participants 49 participants
-0.92  (1.988) -0.73  (2.245) -2.28  (2.271) -2.46  (2.578) -3.63  (3.154)
Itching due to AD Day 13 Number Analyzed 48 participants 44 participants 42 participants 49 participants 48 participants
-1.21  (1.989) -0.68  (1.801) -1.98  (2.268) -2.84  (2.164) -3.88  (3.085)
Itching due to AD Day 14 Number Analyzed 47 participants 41 participants 41 participants 49 participants 47 participants
-1.11  (2.003) -0.78  (2.104) -2.10  (2.211) -2.53  (2.567) -4.06  (2.793)
Itching due to AD Day 15 Number Analyzed 38 participants 35 participants 35 participants 42 participants 38 participants
-1.39  (2.034) -0.69  (1.937) -2.06  (2.508) -2.79  (2.290) -4.37  (2.696)
Itching due to AD Day 29 Number Analyzed 46 participants 41 participants 41 participants 52 participants 49 participants
-1.63  (2.453) -1.34  (2.383) -2.17  (2.519) -3.58  (3.322) -5.00  (2.880)
Itching due to AD Day 43 Number Analyzed 40 participants 37 participants 40 participants 47 participants 50 participants
-1.93  (2.325) -2.24  (2.929) -2.50  (2.562) -3.77  (3.778) -5.02  (3.172)
Itching due to AD Day 57 Number Analyzed 38 participants 34 participants 40 participants 47 participants 46 participants
-1.84  (2.594) -1.97  (3.398) -2.55  (2.943) -4.00  (3.336) -5.26  (3.130)
Itching due to AD Day 85 Number Analyzed 35 participants 30 participants 31 participants 43 participants 44 participants
-2.26  (3.081) -2.13  (3.711) -2.68  (2.749) -4.21  (3.529) -4.84  (3.785)
Itching due to AD Day 99 Number Analyzed 30 participants 27 participants 27 participants 40 participants 41 participants
-1.57  (3.025) -1.48  (2.992) -1.37  (2.452) -2.28  (2.900) -1.90  (3.767)
Itching due to AD Day 113 Number Analyzed 23 participants 24 participants 25 participants 36 participants 34 participants
-2.43  (3.259) -1.38  (3.201) -1.32  (2.410) -2.03  (3.185) -1.50  (3.736)
Frequency of itching due to AD Day 2 Number Analyzed 50 participants 45 participants 47 participants 54 participants 52 participants
-0.06  (1.754) -0.44  (1.198) -0.94  (1.737) -1.35  (1.556) -1.60  (2.345)
Frequency of itching due to AD Day 3 Number Analyzed 50 participants 45 participants 47 participants 53 participants 52 participants
-0.38  (1.894) -0.16  (1.461) -0.79  (2.331) -1.49  (1.694) -1.92  (2.300)
Frequency of itching due to AD Day 4 Number Analyzed 50 participants 44 participants 47 participants 53 participants 51 participants
-0.20  (1.738) -0.32  (1.073) -1.02  (2.162) -1.40  (2.069) -2.47  (2.533)
Frequency of itching due to AD Day 5 Number Analyzed 50 participants 44 participants 47 participants 53 participants 51 participants
-0.42  (1.727) -0.43  (1.516) -1.49  (2.349) -1.75  (1.828) -2.73  (2.515)
Frequency of itching due to AD Day 6 Number Analyzed 50 participants 44 participants 47 participants 53 participants 51 participants
-0.40  (2.250) -0.55  (1.606) -1.40  (2.402) -1.77  (2.326) -3.24  (2.446)
Frequency of itching due to AD Day 7 Number Analyzed 51 participants 44 participants 47 participants 52 participants 51 participants
-0.63  (2.181) -0.43  (1.676) -1.53  (2.466) -2.04  (2.214) -3.15  (2.739)
Frequency of itching due to AD Day 8 Number Analyzed 50 participants 44 participants 46 participants 54 participants 50 participants
-0.42  (2.205) -0.40  (1.679) -1.74  (2.542) -2.59  (2.278) -3.69  (2.808)
Frequency of itching due to AD Day 9 Number Analyzed 48 participants 44 participants 42 participants 52 participants 50 participants
-0.54  (2.240) -0.75  (2.036) -1.74  (2.567) -2.62  (2.268) -3.54  (3.018)
Frequency of itching due to AD Day 10 Number Analyzed 49 participants 44 participants 43 participants 52 participants 50 participants
-0.80  (2.198) -0.64  (2.200) -1.84  (2.760) -2.33  (2.565) -3.68  (2.591)
Frequency of itching due to AD Day 11 Number Analyzed 49 participants 44 participants 43 participants 52 participants 50 participants
-0.96  (2.336) -0.68  (2.380) -1.79  (2.541) -2.46  (2.540) -3.74  (2.633)
Frequency of itching due to AD Day 12 Number Analyzed 49 participants 44 participants 43 participants 52 participants 49 participants
-1.06  (2.322) -0.66  (2.411) -2.00  (2.182) -2.54  (2.509) -3.84  (2.932)
Frequency of itching due to AD Day 13 Number Analyzed 48 participants 44 participants 42 participants 49 participants 48 participants
-1.33  (2.337) -0.91  (2.133) -1.90  (2.195) -2.78  (2.275) -4.08  (2.952)
Frequency of itching due to AD Day 14 Number Analyzed 47 participants 41 participants 41 participants 49 participants 47 participants
-1.17  (2.417) -1.10  (2.417) -2.00  (2.225) -2.63  (2.620) -4.28  (2.841)
Frequency of itching due to AD Day 15 Number Analyzed 38 participants 35 participants 35 participants 42 participants 38 participants
-1.50  (2.322) -0.97  (2.135) -2.17  (2.407) -3.02  (2.464) -4.50  (2.648)
Frequency of itching due to AD Day 29 Number Analyzed 46 participants 41 participants 41 participants 52 participants 49 participants
-1.46  (2.518) -1.34  (2.425) -2.22  (2.761) -3.77  (3.317) -5.06  (2.817)
Frequency of itching due to AD Day 43 Number Analyzed 40 participants 37 participants 40 participants 47 participants 50 participants
-1.70  (1.990) -2.51  (3.061) -2.28  (2.953) -4.02  (3.796) -5.30  (2.957)
Frequency of itching due to AD Day 57 Number Analyzed 38 participants 34 participants 40 participants 47 participants 46 participants
-1.74  (2.298) -2.00  (3.499) -2.45  (2.943) -4.02  (3.467) -5.59  (3.037)
Frequency of itching due to AD Day 85 Number Analyzed 35 participants 30 participants 31 participants 43 participants 44 participants
-2.23  (3.209) -2.33  (3.575) -2.61  (2.692) -4.09  (3.663) -5.14  (3.645)
Frequency of itching due to AD Day 99 Number Analyzed 30 participants 27 participants 27 participants 40 participants 41 participants
-1.30  (2.781) -1.56  (2.736) -0.93  (2.526) -2.03  (3.378) -2.15  (3.909)
Frequency of itching due to AD Day 113 Number Analyzed 23 participants 24 participants 25 participants 36 participants 34 participants
-2.00  (2.970) -1.42  (3.035) -1.04  (2.557) -1.81  (3.188) -1.50  (3.816)
12.Secondary Outcome
Title Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points
Hide Description The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The 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.
Time Frame All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 54 participants 48 participants 50 participants 55 participants 54 participants
9.3 8.3 14.0 12.7 40.7
Week 2 Number Analyzed 55 participants 49 participants 50 participants 55 participants 52 participants
27.3 16.3 24.0 36.4 65.4
Week 4 Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
27.3 30.6 36.0 58.2 85.2
Week 6 Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
36.4 30.6 40.0 60.0 90.7
Week 8 Number Analyzed 55 participants 49 participants 50 participants 55 participants 53 participants
30.9 36.7 40.0 60.0 90.6
Week 12 Number Analyzed 52 participants 46 participants 45 participants 54 participants 48 participants
26.9 26.1 33.3 55.6 79.2
Week 13 Number Analyzed 30 participants 29 participants 31 participants 38 participants 45 participants
43.3 41.4 45.2 55.3 75.6
Week 14 Number Analyzed 32 participants 28 participants 29 participants 40 participants 44 participants
37.5 42.9 37.9 50.0 65.9
Week 16 Number Analyzed 28 participants 26 participants 27 participants 36 participants 38 participants
42.9 42.3 33.3 41.7 68.4
13.Secondary Outcome
Title Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points
Hide Description The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The 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.
Time Frame All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 54 participants 48 participants 50 participants 55 participants 54 participants
3.7 2.1 6.0 3.6 16.7
Week 2 Number Analyzed 55 participants 49 participants 50 participants 55 participants 52 participants
5.5 12.2 6.0 12.7 36.5
Week 4 Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
10.9 18.4 20.0 27.3 57.4
Week 6 Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
16.4 18.4 18.0 38.2 68.5
Week 8 Number Analyzed 55 participants 49 participants 50 participants 55 participants 53 participants
20.0 22.4 22.0 40.0 73.6
Week 12 Number Analyzed 52 participants 46 participants 45 participants 54 participants 48 participants
15.4 17.4 13.3 40.7 64.6
Week 13 Number Analyzed 30 participants 29 participants 31 participants 38 participants 45 participants
26.7 27.6 12.9 36.8 55.6
Week 14 Number Analyzed 32 participants 28 participants 29 participants 40 participants 44 participants
31.3 25.0 6.9 35.0 45.5
Week 16 Number Analyzed 28 participants 26 participants 27 participants 36 participants 38 participants
32.1 38.5 3.7 25.0 36.8
14.Secondary Outcome
Title Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points
Hide Description The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The 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.
Time Frame All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 54 participants 48 participants 50 participants 55 participants 54 participants
0.0 2.1 4.0 0.0 7.4
Week 2 Number Analyzed 55 participants 49 participants 50 participants 55 participants 52 participants
0.0 6.1 4.0 5.5 19.2
Week 4 Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
1.8 8.2 8.0 10.9 38.9
Week 6 Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
7.3 14.3 14.0 16.4 44.4
Week 8 Number Analyzed 55 participants 49 participants 50 participants 55 participants 53 participants
5.5 12.2 8.0 23.6 43.4
Week 12 Number Analyzed 52 participants 46 participants 45 participants 54 participants 48 participants
9.6 10.9 0.0 25.9 52.1
Week 13 Number Analyzed 30 participants 29 participants 31 participants 38 participants 45 participants
10.0 13.8 3.2 23.7 31.1
Week 14 Number Analyzed 32 participants 28 participants 29 participants 40 participants 44 participants
15.6 14.3 0.0 17.5 18.2
Week 16 Number Analyzed 28 participants 26 participants 27 participants 36 participants 38 participants
14.3 23.1 3.7 8.3 10.5
15.Secondary Outcome
Title Change From Baseline in Affected BSA at All Scheduled Time Points
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. Since the scalp, palms, and soles are excluded from the BSA (Efficacy) assessment, the maximum possible value is less than 100%.
Time Frame Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Mean (Standard Deviation)
Unit of Measure: percentage of BSA
Week 1 Number Analyzed 54 participants 48 participants 49 participants 55 participants 53 participants
-0.06  (6.699) -3.76  (13.940) -2.45  (7.017) -4.63  (12.144) -10.86  (15.690)
Week 2 Number Analyzed 55 participants 48 participants 47 participants 53 participants 50 participants
-5.43  (10.030) -4.84  (16.179) -6.51  (10.485) -10.80  (16.432) -21.30  (19.285)
Week 4 Number Analyzed 50 participants 45 participants 47 participants 52 participants 52 participants
-6.34  (16.138) -8.93  (15.960) -9.59  (14.845) -17.77  (19.956) -28.55  (20.447)
Week 6 Number Analyzed 44 participants 38 participants 43 participants 48 participants 52 participants
-10.79  (16.413) -11.80  (22.324) -10.71  (15.007) -18.80  (23.387) -30.51  (20.853)
Week 8 Number Analyzed 41 participants 36 participants 43 participants 47 participants 49 participants
-9.71  (17.837) -12.98  (25.552) -10.79  (19.259) -19.41  (23.596) -29.98  (20.864)
Week 12 Number Analyzed 35 participants 29 participants 30 participants 43 participants 42 participants
-13.82  (22.348) -11.59  (27.112) -9.37  (18.783) -22.21  (22.199) -27.72  (18.361)
Week 13 Number Analyzed 30 participants 29 participants 31 participants 38 participants 45 participants
-7.90  (18.233) -11.07  (25.457) -7.79  (17.469) -17.88  (20.905) -22.61  (22.390)
Week 14 Number Analyzed 32 participants 28 participants 29 participants 40 participants 44 participants
-8.97  (16.223) -10.46  (26.130) -6.33  (17.404) -12.75  (22.492) -16.35  (18.931)
Week 16 Number Analyzed 28 participants 26 participants 27 participants 36 participants 38 participants
-8.09  (15.797) -14.64  (20.948) -3.52  (20.967) -5.55  (21.079) -17.88  (17.059)
16.Secondary Outcome
Title Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points
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 subject or caregiver using a numeric rating scale (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). The 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 and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 Number Analyzed 54 participants 48 participants 49 participants 55 participants 53 participants
-7.910  (12.4625) -5.000  (13.3310) -8.388  (14.6316) -12.024  (12.4053) -21.326  (15.8867)
Week 2 Number Analyzed 55 participants 48 participants 47 participants 53 participants 50 participants
-10.905  (15.4157) -8.795  (16.3883) -13.266  (14.5268) -20.286  (15.2402) -32.152  (14.4354)
Week 4 Number Analyzed 50 participants 45 participants 47 participants 52 participants 52 participants
-14.555  (16.6414) -14.116  (19.1643) -15.496  (16.4795) -28.058  (16.6775) -39.567  (14.7328)
Week 6 Number Analyzed 44 participants 38 participants 43 participants 48 participants 52 participants
-19.527  (16.7869) -16.667  (21.8577) -19.930  (17.5966) -29.729  (21.6156) -41.458  (14.3943)
Week 8 Number Analyzed 41 participants 36 participants 43 participants 47 participants 49 participants
-19.052  (18.5735) -18.853  (21.7947) -19.534  (18.7098) -30.148  (20.7887) -42.604  (13.9771)
Week 12 Number Analyzed 35 participants 29 participants 30 participants 43 participants 42 participants
-18.647  (20.0191) -17.986  (23.1948) -21.211  (17.6774) -33.145  (21.4221) -41.384  (15.4359)
Week 13 Number Analyzed 30 participants 29 participants 31 participants 38 participants 45 participants
-16.603  (21.3850) -16.895  (22.1132) -15.023  (16.1573) -24.261  (19.4912) -29.884  (19.1501)
Week 14 Number Analyzed 32 participants 28 participants 29 participants 40 participants 44 participants
-17.987  (22.0893) -15.842  (19.5000) -12.768  (13.6914) -20.211  (20.2920) -21.292  (17.7775)
Week 16 Number Analyzed 28 participants 26 participants 27 participants 36 participants 38 participants
-19.408  (22.1744) -18.925  (21.5459) -12.716  (15.9390) -17.753  (19.1842) -21.024  (18.1576)
17.Secondary Outcome
Title Percent Change From Baseline in SCORAD at All Scheduled Time Points
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 subject or caregiver using a numeric rating scale (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). The 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 and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Mean (Standard Deviation)
Unit of Measure: percent change
Week 1 Number Analyzed 54 participants 48 participants 49 participants 55 participants 53 participants
-11.547  (19.7128) -7.287  (20.6403) -13.068  (21.0746) -19.185  (20.0094) -34.660  (25.0837)
Week 2 Number Analyzed 55 participants 48 participants 47 participants 53 participants 50 participants
-16.488  (23.0011) -12.980  (25.5198) -20.613  (21.0283) -31.025  (23.9881) -51.384  (21.3581)
Week 4 Number Analyzed 50 participants 45 participants 47 participants 52 participants 52 participants
-22.476  (26.5163) -20.751  (29.0846) -24.866  (25.3755) -43.846  (26.2001) -63.970  (21.6701)
Week 6 Number Analyzed 44 participants 38 participants 43 participants 48 participants 52 participants
-30.789  (27.9424) -25.851  (34.2950) -31.276  (29.6517) -45.270  (34.3893) -66.971  (22.4343)
Week 8 Number Analyzed 41 participants 36 participants 43 participants 47 participants 49 participants
-29.624  (30.5625) -28.599  (33.1460) -30.480  (29.4742) -46.187  (32.7984) -69.736  (21.4403)
Week 12 Number Analyzed 35 participants 29 participants 30 participants 43 participants 42 participants
-29.379  (31.9081) -27.607  (36.5015) -32.535  (25.2711) -51.624  (33.0106) -68.537  (24.2392)
Week 13 Number Analyzed 30 participants 29 participants 31 participants 38 participants 45 participants
-26.794  (34.3384) -26.905  (34.1879) -24.232  (26.2461) -38.193  (32.3458) -48.428  (30.1133)
Week 14 Number Analyzed 32 participants 28 participants 29 participants 40 participants 44 participants
-29.393  (36.6642) -25.511  (31.1985) -20.072  (21.7399) -31.521  (34.1268) -36.519  (28.5404)
Week 16 Number Analyzed 28 participants 26 participants 27 participants 36 participants 38 participants
-31.972  (36.5058) -30.135  (34.2361) -19.794  (25.0550) -29.130  (33.1868) -34.995  (27.4996)
18.Secondary Outcome
Title Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points
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 subject or caregiver using a numeric rating scale (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). The 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 and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 54 participants 48 participants 50 participants 55 participants 54 participants
3.7 2.1 6.0 7.3 29.6
Week 2 Number Analyzed 55 participants 49 participants 50 participants 55 participants 52 participants
5.5 10.2 10.0 18.2 55.8
Week 4 Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
20.0 12.2 16.0 43.6 75.9
Week 6 Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
21.8 16.3 26.0 45.5 74.1
Week 8 Number Analyzed 55 participants 49 participants 50 participants 55 participants 53 participants
23.6 22.4 30.0 43.6 73.6
Week 12 Number Analyzed 52 participants 46 participants 45 participants 54 participants 48 participants
19.2 13.0 15.6 50.0 72.9
Week 13 Number Analyzed 30 participants 29 participants 31 participants 38 participants 45 participants
26.7 20.7 16.1 34.2 48.9
Week 14 Number Analyzed 32 participants 28 participants 29 participants 40 participants 44 participants
31.3 17.9 3.4 32.5 36.4
Week 16 Number Analyzed 28 participants 26 participants 27 participants 36 participants 38 participants
39.3 30.8 14.8 25.0 34.2
19.Secondary Outcome
Title Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points
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 subject or caregiver using a numeric rating scale (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). The 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 and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 54 participants 48 participants 50 participants 55 participants 54 participants
0.0 2.1 2.0 1.8 3.7
Week 2 Number Analyzed 55 participants 49 participants 50 participants 55 participants 52 participants
0.0 2.0 2.0 3.6 11.5
Week 4 Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
1.8 4.1 4.0 14.5 27.8
Week 6 Number Analyzed 55 participants 49 participants 50 participants 55 participants 54 participants
5.5 12.2 4.0 20.0 37.0
Week 8 Number Analyzed 55 participants 49 participants 50 participants 55 participants 53 participants
3.6 6.1 2.0 16.4 35.8
Week 12 Number Analyzed 52 participants 46 participants 45 participants 54 participants 48 participants
3.8 10.9 0.0 18.5 37.5
Week 13 Number Analyzed 30 participants 29 participants 31 participants 38 participants 45 participants
13.3 10.3 0.0 18.4 15.6
Week 14 Number Analyzed 32 participants 28 participants 29 participants 40 participants 44 participants
15.6 7.1 0.0 12.5 11.4
Week 16 Number Analyzed 28 participants 26 participants 27 participants 36 participants 38 participants
14.3 11.5 0.0 11.1 2.6
20.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence in a subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were events that occurred between the first dose of study drug and the subject's last visit (Week 16) that were absent before treatment or that worsened relative to pretreatment state.
Time Frame Baseline till Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: All participants who received at least 1 dose of study treatment.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Measure Type: Number
Unit of Measure: participants
32 34 34 43 41
21.Secondary Outcome
Title Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)
Hide Description [Not Specified]
Time Frame Baseline up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: All participants who received at least 1 dose of study treatment.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Measure Type: Number
Unit of Measure: participants
AEs of anemia 0 0 0 0 0
AEs of neutropenia 0 0 0 0 1
AEs of thrombocytopenia 0 0 0 0 1
AEs of lymphopenia 0 0 0 0 0
AEs of lipid profile 0 0 0 0 0
AEs of liver function tests 0 0 0 0 0
22.Secondary Outcome
Title Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points
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 Physician's Global Assessment was 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 and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 53 participants 48 participants 49 participants 53 participants 54 participants
0.0 2.1 4.1 1.9 16.7
Week 2 Number Analyzed 54 participants 49 participants 49 participants 54 participants 52 participants
5.6 0.0 6.1 16.7 32.7
Week 4 Number Analyzed 53 participants 49 participants 49 participants 54 participants 53 participants
3.8 6.1 8.2 22.2 54.7
Week 6 Number Analyzed 53 participants 49 participants 49 participants 54 participants 54 participants
3.8 10.2 8.2 22.2 51.9
Week 8 Number Analyzed 54 participants 49 participants 49 participants 54 participants 53 participants
1.9 6.1 6.1 24.1 56.6
Week 12 Number Analyzed 54 participants 48 participants 48 participants 54 participants 52 participants
7.4 12.5 0.0 25.9 51.9
Week 14 Number Analyzed 31 participants 29 participants 28 participants 38 participants 45 participants
3.2 10.3 0.0 15.8 15.6
Week 16 Number Analyzed 27 participants 26 participants 26 participants 34 participants 38 participants
11.1 7.7 0.0 11.8 10.5
23.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points
Hide Description The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. 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 2-5 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.
Time Frame Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 Number Analyzed 53 participants 48 participants 48 participants 54 participants 53 participants
-1.4  (6.04) -1.4  (5.66) -3.4  (6.28) -5.1  (5.40) -6.3  (5.55)
Week 2 Number Analyzed 53 participants 48 participants 46 participants 52 participants 50 participants
-2.3  (5.42) -1.9  (6.58) -5.0  (5.55) -7.5  (6.39) -8.6  (6.46)
Week 4 Number Analyzed 48 participants 45 participants 45 participants 51 participants 51 participants
-2.6  (6.77) -3.7  (7.33) -4.7  (5.62) -8.2  (7.48) -9.7  (6.82)
Week 6 Number Analyzed 42 participants 38 participants 42 participants 47 participants 52 participants
-4.2  (6.01) -4.6  (7.30) -4.1  (7.75) -9.1  (6.75) -10.2  (6.72)
Week 8 Number Analyzed 40 participants 36 participants 42 participants 46 participants 49 participants
-3.7  (7.67) -5.6  (8.44) -4.8  (8.52) -9.2  (7.95) -9.8  (7.10)
Week 12 Number Analyzed 36 participants 31 participants 33 participants 43 participants 46 participants
-4.6  (8.49) -4.5  (8.90) -5.2  (7.30) -9.8  (8.18) -9.5  (7.28)
Week 14 Number Analyzed 31 participants 29 participants 28 participants 39 participants 45 participants
-3.1  (8.24) -3.9  (7.62) -3.6  (6.60) -6.2  (7.87) -4.4  (8.78)
Week 16 Number Analyzed 27 participants 26 participants 26 participants 34 participants 38 participants
-4.5  (7.95) -4.5  (7.14) -3.5  (7.17) -4.6  (7.62) -3.6  (7.39)
24.Secondary Outcome
Title Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points
Hide Description The POEM is a 7-item patient reported outcome (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 and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 Number Analyzed 53 participants 48 participants 48 participants 53 participants 50 participants
-1.1  (3.59) -0.6  (4.17) -2.1  (5.83) -3.9  (4.67) -9.2  (5.77)
Week 2 Number Analyzed 51 participants 48 participants 45 participants 50 participants 50 participants
-2.2  (4.20) -1.9  (6.13) -4.1  (6.04) -7.2  (6.79) -11.9  (5.95)
Week 4 Number Analyzed 48 participants 45 participants 44 participants 50 participants 50 participants
-2.2  (6.05) -3.6  (6.35) -4.3  (5.69) -8.7  (8.30) -14.6  (6.20)
Week 6 Number Analyzed 41 participants 38 participants 42 participants 45 participants 50 participants
-3.5  (5.24) -4.3  (7.63) -3.9  (7.43) -10.4  (8.17) -15.0  (5.92)
Week 8 Number Analyzed 40 participants 36 participants 42 participants 45 participants 48 participants
-2.3  (5.91) -4.3  (8.94) -5.4  (8.05) -10.6  (8.47) -15.2  (6.15)
Week 12 Number Analyzed 36 participants 31 participants 33 participants 41 participants 45 participants
-3.8  (8.21) -4.7  (8.83) -5.3  (7.60) -11.4  (8.08) -15.1  (6.99)
Week 14 Number Analyzed 31 participants 29 participants 28 participants 38 participants 44 participants
-2.2  (6.45) -3.9  (8.04) -2.7  (6.05) -6.3  (7.12) -6.2  (6.97)
Week 16 Number Analyzed 27 participants 26 participants 26 participants 34 participants 37 participants
-3.0  (7.76) -3.0  (7.67) -2.2  (6.80) -4.3  (6.20) -5.9  (5.93)
25.Secondary Outcome
Title Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points
Hide Description The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. The HADS was completed as per schedule of activities. 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 and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of Participants Analyzed" represents the number of participants in the FAS population. "Number Analyzed" at each visit represents the number of evaluable subjects for that visit.
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description:
Participants received matching placebo tablets for a 12-week double-blind treatment period.
Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period.
Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
Overall Number of Participants Analyzed 56 49 51 56 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
Depression score Week 1 Number Analyzed 53 participants 48 participants 48 participants 54 participants 53 participants
-0.5  (2.71) 0.0  (2.38) -0.6  (2.49) -0.9  (2.94) -1.0  (2.16)
Depression score Week 2 Number Analyzed 53 participants 48 participants 46 participants 52 participants 50 participants
-0.5  (2.78) 0.4  (2.99) -1.1  (1.85) -1.2  (2.93) -1.8  (2.66)
Depression score Week 4 Number Analyzed 47 participants 45 participants 45 participants 51 participants 51 participants
-0.5  (3.00) -0.4  (3.26) -0.8  (2.05) -1.5  (3.35) -2.1  (3.30)
Depression score Week 8 Number Analyzed 41 participants 36 participants 42 participants 46 participants 50 participants
-0.7  (3.31) -1.3  (3.76) -0.9  (2.84) -2.1  (3.35) -1.7  (3.08)
Depression score Week 12 Number Analyzed 36 participants 31 participants 33 participants 43 participants 46 participants
-0.9  (3.96) -0.9  (3.65) -0.5  (2.83) -2.4  (3.74) -1.8  (3.90)
Depression score Week 14 Number Analyzed 31 participants 29 participants 28 participants 39 participants 45 participants
0.1  (3.41) -1.2  (3.50) -0.9  (1.53) -1.7  (4.31) -0.1  (4.18)
Depression score Week 16 Number Analyzed 27 participants 26 participants 26 participants 34 participants 38 participants
-0.7  (3.18) -1.1  (3.59) -1.0  (1.85) -1.4  (3.93) -0.1  (3.57)
Anxiety score Week 1 Number Analyzed 53 participants 48 participants 48 participants 54 participants 53 participants
-1.0  (2.66) 0.2  (2.41) -0.2  (2.49) -1.1  (2.26) -1.2  (2.71)
Anxiety score Week 2 Number Analyzed 53 participants 48 participants 46 participants 52 participants 50 participants
-1.5  (2.87) -0.4  (2.56) -0.9  (2.88) -1.7  (2.81) -2.4  (3.15)
Anxiety score Week 4 Number Analyzed 47 participants 46 participants 45 participants 51 participants 51 participants
-1.6  (3.18) -1.0  (2.80) -0.7  (2.69) -1.7  (2.95) -2.4  (4.04)
Anxiety score Week 8 Number Analyzed 41 participants 36 participants 42 participants 46 participants 50 participants
-1.7  (2.33) -1.6  (2.67) -1.4  (3.21) -2.7  (3.44) -2.5  (3.31)
Anxiety score Week 12 Number Analyzed 36 participants 31 participants 33 participants 43 participants 46 participants
-2.6  (3.01) -1.5  (2.85) -1.0  (3.43) -2.8  (3.71) -2.5  (3.51)
Anxiety score Week 14 Number Analyzed 31 participants 29 participants 28 participants 39 participants 45 participants
-2.3  (3.43) -1.5  (3.17) -1.4  (2.96) -2.0  (3.49) -1.5  (3.93)
Anxiety score Week 16 Number Analyzed 27 participants 26 participants 26 participants 34 participants 38 participants
-2.9  (3.75) -2.2  (3.38) -0.7  (3.27) -1.4  (3.85) -1.5  (3.10)
Time Frame Baseline up to Week 16
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Hide Arm/Group Description Participants received matching placebo tablets for a 12-week double-blind treatment period. Participants received PF-04965842 10 mg once daily for a 12-week double-blind treatment period. Participants received PF-04965842 30 mg once daily for a 12-week double-blind treatment period. Participants received PF-04965842 100 mg once daily for a 12-week double-blind treatment period. Participants received PF-04965842 200 mg once daily for a 12-week double-blind treatment period.
All-Cause Mortality
Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/49 (0.00%)   0/51 (0.00%)   0/56 (0.00%)   0/55 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/56 (3.57%)   2/49 (4.08%)   0/51 (0.00%)   3/56 (5.36%)   2/55 (3.64%) 
Infections and infestations           
Eczema herpeticum * 1  0/56 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  1/56 (1.79%)  0/55 (0.00%) 
Pneumonia * 1  0/56 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/56 (0.00%)  1/55 (1.82%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Malignant melanoma * 1  0/56 (0.00%)  1/49 (2.04%)  0/51 (0.00%)  0/56 (0.00%)  0/55 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Asthma * 1  0/56 (0.00%)  1/49 (2.04%)  0/51 (0.00%)  1/56 (1.79%)  0/55 (0.00%) 
Pulmonary embolism * 1  0/56 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  0/56 (0.00%)  1/55 (1.82%) 
Skin and subcutaneous tissue disorders           
Dermatitis atopic * 1  1/56 (1.79%)  0/49 (0.00%)  0/51 (0.00%)  1/56 (1.79%)  0/55 (0.00%) 
Dermatitis exfoliative * 1  1/56 (1.79%)  0/49 (0.00%)  0/51 (0.00%)  0/56 (0.00%)  0/55 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo PF-04965842 10mg QD PF-04965842 30mg QD PF-04965842 100mg QD PF-04965842 200mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/56 (30.36%)   18/49 (36.73%)   25/51 (49.02%)   25/56 (44.64%)   27/55 (49.09%) 
Gastrointestinal disorders           
Diarrhoea * 1  1/56 (1.79%)  3/49 (6.12%)  1/51 (1.96%)  1/56 (1.79%)  5/55 (9.09%) 
Nausea * 1  1/56 (1.79%)  3/49 (6.12%)  3/51 (5.88%)  1/56 (1.79%)  8/55 (14.55%) 
Infections and infestations           
Upper respiratory tract infection * 1  5/56 (8.93%)  3/49 (6.12%)  5/51 (9.80%)  3/56 (5.36%)  5/55 (9.09%) 
Viral upper respiratory tract infection * 1  5/56 (8.93%)  5/49 (10.20%)  6/51 (11.76%)  10/56 (17.86%)  7/55 (12.73%) 
Nervous system disorders           
Dizziness * 1  0/56 (0.00%)  0/49 (0.00%)  1/51 (1.96%)  0/56 (0.00%)  3/55 (5.45%) 
Headache * 1  2/56 (3.57%)  2/49 (4.08%)  5/51 (9.80%)  5/56 (8.93%)  4/55 (7.27%) 
Skin and subcutaneous tissue disorders           
Dermatitis atopic * 1  6/56 (10.71%)  8/49 (16.33%)  9/51 (17.65%)  7/56 (12.50%)  7/55 (12.73%) 
Dermatitis contact * 1  0/56 (0.00%)  0/49 (0.00%)  0/51 (0.00%)  3/56 (5.36%)  0/55 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02780167     History of Changes
Other Study ID Numbers: B7451006
2015-005513-72 ( EudraCT Number )
First Submitted: April 11, 2016
First Posted: May 23, 2016
Results First Submitted: February 23, 2018
Results First Posted: May 16, 2018
Last Update Posted: May 2, 2019