Clinical Trial Results:
A Phase 3 Randomized, DoubleBlind, PlaceboControlled, Parallel Group, MultiCenter Study to Evaluate the Efficacy and Safety of PF04965842 Monotherapy in Subjects Aged 12 Years and Older, With Moderate to Severe Atopic Dermatitis
Summary


EudraCT number 
201800113621 
Trial protocol 
BG HU CZ GB DE PL LV 
Global end of trial date 
13 Aug 2019

Results information


Results version number 
v1(current) 
This version publication date 
07 Feb 2020

First version publication date 
07 Feb 2020

Other versions 
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information


Trial identification


Sponsor protocol code 
B7451013


Additional study identifiers


ISRCTN number 
  
US NCT number 
NCT03575871  
WHO universal trial number (UTN) 
  
Sponsors


Sponsor organisation name 
Pfizer Inc.


Sponsor organisation address 
235 E 42nd Street, New York, United States, NY 10017


Public contact 
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com


Scientific contact 
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com


Paediatric regulatory details


Is trial part of an agreed paediatric investigation plan (PIP) 
No


Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? 
No


Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? 
Yes


Results analysis stage


Analysis stage 
Final


Date of interim/final analysis 
13 Aug 2019


Is this the analysis of the primary completion data? 
No


Global end of trial reached? 
Yes


Global end of trial date 
13 Aug 2019


Was the trial ended prematurely? 
No


General information about the trial


Main objective of the trial 
To assess the efficacy of PF04965842 compared with placebo in subjects aged
12 years and older with moderate to severe AD


Protection of trial subjects 
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.


Background therapy 
  
Evidence for comparator 
  
Actual start date of recruitment 
29 Jun 2018


Long term followup planned 
No


Independent data monitoring committee (IDMC) involvement? 
Yes


Population of trial subjects


Number of subjects enrolled per country 

Country: Number of subjects enrolled 
Australia: 32


Country: Number of subjects enrolled 
Bulgaria: 22


Country: Number of subjects enrolled 
Canada: 23


Country: Number of subjects enrolled 
China: 24


Country: Number of subjects enrolled 
Czech Republic: 14


Country: Number of subjects enrolled 
Germany: 39


Country: Number of subjects enrolled 
Hungary: 13


Country: Number of subjects enrolled 
Japan: 44


Country: Number of subjects enrolled 
Korea, Republic of: 35


Country: Number of subjects enrolled 
Latvia: 12


Country: Number of subjects enrolled 
Poland: 52


Country: Number of subjects enrolled 
United Kingdom: 23


Country: Number of subjects enrolled 
United States: 58


Worldwide total number of subjects 
391


EEA total number of subjects 
175


Number of subjects enrolled per age group 

In utero 
0


Preterm newborn  gestational age < 37 wk 
0


Newborns (027 days) 
0


Infants and toddlers (28 days23 months) 
0


Children (211 years) 
0


Adolescents (1217 years) 
40


Adults (1864 years) 
332


From 65 to 84 years 
19


85 years and over 
0



Recruitment


Recruitment details 
Subjects with age greater than or equal to (>=) 12 years with moderate to severe atopic dermatitis (AD) and a body weight of >=40 kilograms were enrolled in the study. Eligible subjects had an option to enter into a longterm extension (LTE) study after completing 12 weeks of treatment in this study.  
Preassignment


Screening details 
This study was conducted from 29June2018 to 13Aug2019 at 106 sites in 13 countries.  
Period 1


Period 1 title 
Overall Study (overall period)


Is this the baseline period? 
Yes  
Allocation method 
Randomised  controlled


Blinding used 
Double blind  
Roles blinded 
Investigator, Carer, Assessor, Subject  
Arms


Are arms mutually exclusive 
Yes


Arm title

PF04965842 100 mg  
Arm description 
Subjects were randomized to receive a tablet of PF04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.  
Arm type 
Experimental  
Investigational medicinal product name 
Abrocitinib


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Tablet


Routes of administration 
Oral use


Dosage and administration details 
Subjects received 100 milligram (mg) tablet orally once daily for 12 weeks


Arm title

PF04965842 200 mg  
Arm description 
Subjects were randomized to receive PF04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.  
Arm type 
Experimental  
Investigational medicinal product name 
Abrocitinib


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Tablet


Routes of administration 
Oral use


Dosage and administration details 
Subjects received 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks.


Arm title

Placebo  
Arm description 
Subjects were randomized to receive 2 tablets of placebo matched to PF04965842 100 mg orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.  
Arm type 
Placebo  
Investigational medicinal product name 
Placebo


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Tablet


Routes of administration 
Oral use


Dosage and administration details 
Subjects received 2 tablets of placebo matched to PF04965842 100 mg orally once daily for 12 weeks.





Baseline characteristics reporting groups


Reporting group title 
PF04965842 100 mg


Reporting group description 
Subjects were randomized to receive a tablet of PF04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.  
Reporting group title 
PF04965842 200 mg


Reporting group description 
Subjects were randomized to receive PF04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.  
Reporting group title 
Placebo


Reporting group description 
Subjects were randomized to receive 2 tablets of placebo matched to PF04965842 100 mg orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.  



End points reporting groups


Reporting group title 
PF04965842 100 mg


Reporting group description 
Subjects were randomized to receive a tablet of PF04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.  
Reporting group title 
PF04965842 200 mg


Reporting group description 
Subjects were randomized to receive PF04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.  
Reporting group title 
Placebo


Reporting group description 
Subjects were randomized to receive 2 tablets of placebo matched to PF04965842 100 mg orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug. 


End point title 
Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12  
End point description 
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0=clear, no inflammatory signs of AD; 1=almost clear, AD not fully cleared light pink residual lesions (except postinflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2=mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3=moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4=severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp. Full analysis set included all randomized subjects who received at least 1 dose of study drug. Number of Subjects Analysed signifies subjects evaluable for this endpoint.


End point type 
Primary


End point timeframe 
Baseline, Week 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
232


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0008 ^{[1]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
19.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.6  
upper limit 
29  
Notes [1]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
232


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[2]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
28.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
18.6  
upper limit 
38.8  
Notes [2]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 


End point title 
Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI75) From Baseline at Week 12  
End point description 
EASI evaluates severity of subject's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score=0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au (Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al (El+Il+Exl+Ll); A=EASI area score; E=erythema; I=induration/papulation; Ex=excoriation; L= lichenification; h=head and neck; u=upper limbs; t=trunk; l=lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.


End point type 
Primary


End point timeframe 
Baseline, Week 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
232


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[3]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
33.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
23.3  
upper limit 
44.4  
Notes [3]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
231


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[4]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
50.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
40  
upper limit 
60.9  
Notes [4]  Pvalue was adjusted by randomization strata (baseline disease severity and age category) 


End point title 
Percentage of Subjects who Achieved at Least 4Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12  
End point description 
Subjects were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “Number of Subjects Analyzed” signifies subjects evaluable for this endpoint.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4, 8, and 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
232


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0002 ^{[5]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
19.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11  
upper limit 
27.4  
Notes [5]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
229


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[6]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
31.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
22.3  
upper limit 
40.2  
Notes [6]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
232


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[7]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
27.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
18.9  
upper limit 
36.2  
Notes [7]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
229


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[8]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
46.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
37.2  
upper limit 
55.7  
Notes [8]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
232


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[9]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
27.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
16.8  
upper limit 
38  
Notes [9]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
229


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[10]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
39.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
28.9  
upper limit 
50.6  
Notes [10]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
232


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[11]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
29.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
18.9  
upper limit 
39.6  
Notes [11]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
229


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[12]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
38.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
28.1  
upper limit 
49.1  
Notes [12]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 


End point title 
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12  
End point description 
PSAAD is a daily subject reported symptom electronic diary. Subjects rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Subject had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.


End point type 
Secondary


End point timeframe 
Baseline, Week 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
1.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.3  
upper limit 
1.1  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
232


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
2.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.8  
upper limit 
1.6 


End point title 
Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus  
End point description 
Subjects were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “Number of Subjects Analysed” signifies subjects evaluable for this endpoint.


End point type 
Secondary


End point timeframe 
Baseline up to Day 15




Notes [13]  Here, '99999' indicate that upper limit was not evaluable as too few events were observed. [14]  Here, '99999' indicate that upper limit was not evaluable as too few events were observed. [15]  Here, '99999' indicate that upper limit was not evaluable as too few events were observed. 

No statistical analyses for this end point 


End point title 
Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI75) From Baseline at Weeks 2, 4 and 8  
End point description 
EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score=0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll); A=EASI area score; E=erythema; I=induration/papulation; Ex=excoriation; L= lichenification; h=head and neck; u=upper limbs; t=trunk; l=lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, "n" signifies subjects evaluable for this endpoint at specified time points.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4 and 8




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.015 ^{[16]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
8.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.8  
upper limit 
14.9  
Notes [16]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[17]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
22.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
15  
upper limit 
30.3  
Notes [17]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0004 ^{[18]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
20


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.9  
upper limit 
29  
Notes [18]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[19]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
44.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
34.8  
upper limit 
53.8  
Notes [19]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[20]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
30.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
19.7  
upper limit 
41.2  
Notes [20]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[21]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
47.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
36.8  
upper limit 
58  
Notes [21]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 


End point title 
Percentage of Subjects Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 points Improvement From Baseline at Weeks 2, 4 and 8  
End point description 
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared light pink residual lesions (except postinflammatory hyperpigmentation), erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4, and 8




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0459 ^{[22]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
5.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.2  
upper limit 
10  
Notes [22]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0005 ^{[23]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
14.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.8  
upper limit 
20.5  
Notes [23]  Pvalue was adjusted by randomization strata (baseline disease severity and age category) 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0019 ^{[24]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
12.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.3  
upper limit 
19.4  
Notes [24]  Pvalue was adjusted by randomization strata (baseline disease severity and age category) 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[25]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
31.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
23.6  
upper limit 
39.9  
Notes [25]  Pvalue was adjusted by randomization strata (baseline disease severity and age category) 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0246 ^{[26]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
11.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.4  
upper limit 
21.4  
Notes [26]  Pvalue was adjusted by randomization strata (baseline disease severity and age category) 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[27]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
26.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
17  
upper limit 
36.9  
Notes [27]  Pvalue was adjusted by randomization strata (baseline disease severity and age category) 


End point title 
Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12  
End point description 
IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared light pink residual lesions (except postinflammatory hyperpigmentation), just perceptible erythema, induration lichenification, excoriation, and no oozing; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.


End point type 
Secondary


End point timeframe 
Weeks 2, 4, 8, and 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.7  
upper limit 
3.7  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.2262 ^{[28]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
1.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.2  
upper limit 
6.1  
Notes [28]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.2223 ^{[29]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
1.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.2  
upper limit 
6.1  
Notes [29]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0597 ^{[30]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
4.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.2  
upper limit 
9.2  
Notes [30]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.3207 ^{[31]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
1.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.7  
upper limit 
5.2  
Notes [31]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0586 ^{[32]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
4.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.2  
upper limit 
9.2  
Notes [32]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0419 ^{[33]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
5.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.3  
upper limit 
10.1  
Notes [33]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0244 ^{[34]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
6.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.2  
upper limit 
11.4  
Notes [34]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 


End point title 
Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI50) From Baseline at Weeks 2, 4, 8 and 12  
End point description 
EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score=0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll); A=EASI area score; E=erythema; I=induration/papulation; Ex=excoriation; L= lichenification; h=head and neck; u=upper limbs; t=trunk; l=lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4, 8, and 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[35]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
25


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
14.8  
upper limit 
35.2  
Notes [35]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[36]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
44.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
33.9  
upper limit 
54.6  
Notes [36]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[37]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
30.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
17.5  
upper limit 
42.8  
Notes [37]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[38]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
49.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
37.8  
upper limit 
61.7  
Notes [38]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[39]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
31.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
18.8  
upper limit 
44.3  
Notes [39]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[40]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
47.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
35.7  
upper limit 
59.6  
Notes [40]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[41]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
48.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
37.2  
upper limit 
60.1  
Notes [41]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[42]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
60.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
49.1  
upper limit 
71  
Notes [42]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 


End point title 
Percentage of Subjects Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI90) From Baseline at Weeks 2, 4, 8 and 12  
End point description 
EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score=0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll); A=EASI area score; E=erythema; I=induration/papulation; Ex=excoriation; L= lichenification; h=head and neck; u=upper limbs; t=trunk; l=lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4, 8, 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.1623 ^{[43]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
2.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.7  
upper limit 
6.8  
Notes [43]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.007 ^{[44]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
9.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.4  
upper limit 
14.7  
Notes [44]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0049 ^{[45]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
9.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4  
upper limit 
15.4  
Notes [45]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[46]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
22.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
15.5  
upper limit 
30.2  
Notes [46]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0013 ^{[47]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
14.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.2  
upper limit 
22  
Notes [47]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[48]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
31.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
23.1  
upper limit 
40.1  
Notes [48]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0001 ^{[49]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
20.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.9  
upper limit 
28.3  
Notes [49]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
33.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
24.6  
upper limit 
42.5 


End point title 
Percentage of Subjects Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI100) From Baseline at Weeks 2, 4, 8 and 12  
End point description 
EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score=0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll); A=EASI area score; E=erythema; I=induration/papulation; Ex=excoriation; L= lichenification; h=head and neck; u=upper limbs; t=trunk; l=lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. Here, “n” signifies the number of subjects evaluable at specified time points.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4, 8, and 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0 ^{[50]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.7  
upper limit 
3.7  
Notes [50]  Pvalue could not be calculated since percentage of subjects with events was 0. 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.3261 ^{[51]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
1.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.8  
upper limit 
5.3  
Notes [51]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.3207 ^{[52]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
1.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.7  
upper limit 
5.3  
Notes [52]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.081 ^{[53]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
3.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.8  
upper limit 
8.5  
Notes [53]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.3207 ^{[54]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
1.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.7  
upper limit 
5.2  
Notes [54]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.081 ^{[55]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
3.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.7  
upper limit 
8.4  
Notes [55]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0419 ^{[56]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
5.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.3  
upper limit 
10.1  
Notes [56]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.018 ^{[57]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.8  
upper limit 
12.2  
Notes [57]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 


End point title 
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12  
End point description 
EASI evaluates severity of subjects AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity scored on 4point scale: 0=absent; 1=mild; 2=moderate; 3=severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score=0.1*Ah*(Eh+Ih+Exh+Lh)+0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll); A=EASI area score; E=erythema; I=induration/papulation; Ex=excoriation; L= lichenification; h=head and neck; u=upper limbs; t=trunk; l=lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4, 8, and 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
30.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
38.1  
upper limit 
22.3  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
42.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
50.3  
upper limit 
34.4  
Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
29.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
38.1  
upper limit 
21.7  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
44.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
52.8  
upper limit 
36.3  
Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
26.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
36.2  
upper limit 
16.7  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
40.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
50  
upper limit 
30.4  
Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
31.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
43.1  
upper limit 
19.7  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
44.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
56.4  
upper limit 
33 


End point title 
Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12  
End point description 
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated by handprint method. Number of handprints fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA calculated: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, higher values = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4, 8, and 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
26.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
35.5  
upper limit 
17.5  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
34.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
43.1  
upper limit 
25.1  
Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
29.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
39  
upper limit 
20.4  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
40.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
49.8  
upper limit 
31.1  
Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
32.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
44.6  
upper limit 
21.2  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
40.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
52.2  
upper limit 
28.9  
Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
39.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
51.8  
upper limit 
27.4  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
48.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
60.4  
upper limit 
36 


End point title 
Percentage of Subjects With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12  
End point description 
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. SA of body region: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values = greater severity of AD. Full analysis set included all randomized subjects who received at least 1 dose of study medication. “n” = the number of subjects evaluable at specified time points.


End point type 
Secondary


End point timeframe 
Weeks 2, 4, 8, and 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.2353 ^{[58]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
1.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.2  
upper limit 
6  
Notes [58]  Pvalue was adjusted by randomization strata (baseline disease severity and age category) 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0332 ^{[59]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
5.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.8  
upper limit 
10.8  
Notes [59]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0227 ^{[60]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
6.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.4  
upper limit 
11.6  
Notes [60]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0001 ^{[61]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
16.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.1  
upper limit 
23.5  
Notes [61]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0008 ^{[62]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
14.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.7  
upper limit 
21.3  
Notes [62]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[63]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
25.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
18.1  
upper limit 
33.4  
Notes [63]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0003 ^{[64]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
18.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.5  
upper limit 
26.5  
Notes [64]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
30.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
21.4  
upper limit 
39 


End point title 
Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12  
End point description 
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA  head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0100). Severity (B): severity of each sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (018). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by subject/caregiver using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (020). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. Full analysis set population included. Number Analyzed = number of subjects evaluable at the specified time points.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4, 8, and 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0011 ^{[65]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
12.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.5  
upper limit 
18.9  
Notes [65]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[66]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
32.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
24.6  
upper limit 
40.6  
Notes [66]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[67]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
28.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
18.5  
upper limit 
38.2  
Notes [67]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[68]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
52.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
43.2  
upper limit 
62.5  
Notes [68]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[69]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
28


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
17  
upper limit 
39  
Notes [69]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[70]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
46.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
35.2  
upper limit 
57.1  
Notes [70]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[71]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
36.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
25.4  
upper limit 
47.1  
Notes [71]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[72]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
49.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
38.9  
upper limit 
60.3  
Notes [72]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 


End point title 
Percentage of Subjects Achieving Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12  
End point description 
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA  head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0100). Severity (B): severity of each sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (018). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by subject/caregiver using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (020). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. Full analysis set population included. Number Analyzed = number of subjects evaluable at the specified time points.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4, 8, and 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.2261 ^{[73]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
1.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.2  
upper limit 
6  
Notes [73]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0451 ^{[74]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
5.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.3  
upper limit 
10  
Notes [74]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0171 ^{[75]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.8  
upper limit 
12.3  
Notes [75]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[76]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
17.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.9  
upper limit 
24.5  
Notes [76]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0018 ^{[77]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
11.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.5  
upper limit 
17.5  
Notes [77]  Pvalue was adjusted by randomization strata (baseline disease severity and age category) 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[78]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
25.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
18.3  
upper limit 
33.1  
Notes [78]  Pvalue was adjusted by randomization strata (baseline disease severity and age category) 

Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0005 ^{[79]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
16.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
8.8  
upper limit 
23.6  
Notes [79]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 

Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001 ^{[80]}  
Method 
CochranMantelHaenszel  
Parameter type 
Difference in Percentage  
Point estimate 
27.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
19.3  
upper limit 
35.8  
Notes [80]  Pvalue was adjusted by randomization strata (baseline disease severity and age category). 


End point title 
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12  
End point description 
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA  head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0100). Severity (B): severity sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2, severe=3. The severity scores summed to give B (018). Subjective symptoms (C): pruritus and sleep, these 2 were scored by subject using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness summed to give 'C' (020). The SCORAD was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. This endpoint was not analyzed as planned because the severity assessment of itch was measured more effectively in other endpoints, such as the numerical rating scale.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4, 8, and 12




Notes [81]  Endpoint was not analyzed as itch was measured more effectively in other endpoints using the NRS. [82]  Endpoint was not analyzed as itch was measured more effectively in other endpoints using the NRS. [83]  Endpoint was not analyzed as itch was measured more effectively in other endpoints using the NRS. 

No statistical analyses for this end point 


End point title 
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12  
End point description 
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA  head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0100). Severity (B): severity of each sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (018). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by subject/caregiver using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (020). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. Full analysis population set included. Number Analyzed = number of subjects evaluable at the specified time points.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4, 8, and 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
1.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2  
upper limit 
0.8  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
2.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3  
upper limit 
1.8  
Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
1.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.4  
upper limit 
1.2  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.6  
upper limit 
2.3  
Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
1.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.3  
upper limit 
0.9  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
2.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.1  
upper limit 
1.7  
Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.0164  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
0.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.7  
upper limit 
0.2  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and unstructured covariance matrix


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
1.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.5  
upper limit 
1 


End point title 
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12  
End point description 
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA of whole BSA  head and neck 9%; upper limbs 9%; lower limbs 18%; anterior trunk 18%; back 18%; 1% for genitals. The score was added to determine A (0100). Severity (B): severity of each sign (erythema; edema; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (018). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by subject/caregiver using visual analogue scale (VAS) where 0=no itch/ sleeplessness and 10=the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (020). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse. Full analysis population set included.


End point type 
Secondary


End point timeframe 
Baseline, Weeks 2, 4, 8, and 12




Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
20.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
26.6  
upper limit 
15.1  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
32.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
37.9  
upper limit 
26.4  
Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
21.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
28.1  
upper limit 
15.2  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
35.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
42.3  
upper limit 
29.4  
Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
19.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
26.8  
upper limit 
12.1  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
33.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
41  
upper limit 
26.3  
Statistical analysis title 
PF04965842 100 mg Versus Placebo  
Statistical analysis description 
Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 100 mg v Placebo


Number of subjects included in analysis 
236


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
23.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
32.3  
upper limit 
13.9  
Statistical analysis title 
PF04965842 200 mg Versus Placebo  
Statistical analysis description 
Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.


Comparison groups 
PF04965842 200 mg v Placebo


Number of subjects included in analysis 
233


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.0001  
Method 
Mixed models analysis  
Parameter type 
Difference in LS mean  
Point estimate 
33.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
42.6  
upper limit 
24.3 


Adverse events information


Timeframe for reporting adverse events 
Baseline up to Week 16


Adverse event reporting additional description 
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 subject and as nonserious in another subject or 1 subject may have experienced both serious and nonserious event during study.


Assessment type 
Nonsystematic  
Dictionary used for adverse event reporting


Dictionary name 
MedDRA  
Dictionary version 
22.0


Reporting groups


Reporting group title 
PF04965842 100 mg


Reporting group description 
Subjects were randomized to receive a tablet of PF04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.  
Reporting group title 
Placebo


Reporting group description 
Subjects were randomized to receive 2 tablets of placebo matched to PF04965842 100 mg orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.  
Reporting group title 
PF04965842 200 mg


Reporting group description 
Subjects were randomized to receive PF04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Subjects who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.  


Frequency threshold for reporting nonserious adverse events: 5%  



Substantial protocol amendments (globally) 

Were there any global substantial amendments to the protocol? No  
Interruptions (globally) 

Were there any global interruptions to the trial? No  
Limitations and caveats 

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.  
None reported 