Trial Outcomes & Findings for Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis (NCT NCT03349060)

Results Overview

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 post-inflammatory 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 sole, palms and scalp.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

387 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2019-12-10

Participant Flow

Participants with age greater than or equal to (\>=) 12 years with moderate to severe atopic dermatitis (AD) and a body weight of \>=40 kilogram were enrolled in the study. Eligible participants had an option to enter into a long-term extension (LTE) study after completing 12 weeks of treatment in this study.

This study was conducted from 07-December-2017 to 26-March-2019 at 76 sites in 8 countries.

Participant milestones

Participant milestones
Measure	PF-04965842 100 mg Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Overall Study STARTED	156	154	77
Overall Study COMPLETED	135	137	61
Overall Study NOT COMPLETED	21	17	16

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-04965842 100 mg Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Overall Study Adverse Event	9	9	7
Overall Study Lack of Efficacy	1	0	2
Overall Study Lost to Follow-up	2	1	1
Overall Study Protocol Violation	2	2	1
Overall Study Withdrawal by Subject	5	3	4
Overall Study Medication error,no linked adverse event	0	0	1
Overall Study Withdrawal By Parent/Guardian	0	1	0
Overall Study Other	2	1	0

Baseline Characteristics

Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-04965842 100 mg n=156 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=154 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.	Total n=387 Participants Total of all reporting groups
Age, Continuous	32.6 years STANDARD_DEVIATION 15.4 • n=5 Participants	33.0 years STANDARD_DEVIATION 17.4 • n=7 Participants	31.5 years STANDARD_DEVIATION 14.4 • n=5 Participants	32.5 years STANDARD_DEVIATION 16.0 • n=4 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	73 Participants n=7 Participants	28 Participants n=5 Participants	167 Participants n=4 Participants
Sex: Female, Male Male	90 Participants n=5 Participants	81 Participants n=7 Participants	49 Participants n=5 Participants	220 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	144 Participants n=5 Participants	149 Participants n=7 Participants	71 Participants n=5 Participants	364 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants	26 Participants n=7 Participants	6 Participants n=5 Participants	58 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) White	113 Participants n=5 Participants	104 Participants n=7 Participants	62 Participants n=5 Participants	279 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

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 post-inflammatory 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 sole, palms and scalp.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=156 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=153 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=76 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants 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	23.7 percentage of participants	43.8 percentage of participants	7.9 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point 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.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=156 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=153 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=76 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12	39.7 percentage of participants	62.7 percentage of participants	11.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Participants 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.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=147 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=147 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=74 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS) Week 2	20.4 percentage of participants	45.6 percentage of participants	2.7 percentage of participants
Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS) Week 4	32.2 percentage of participants	58.8 percentage of participants	17.2 percentage of participants
Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS) Week 8	34.3 percentage of participants	59.9 percentage of participants	14.4 percentage of participants
Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS) Week 12	37.7 percentage of participants	57.2 percentage of participants	15.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 12

Population: Per-protocol analysis set included all randomized participants who received at least 1 dose of study medication and who had no major protocol violations. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Participants 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.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=127 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=126 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=54 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale for Severity of Pruritus at Week 2, 4 and 12: Per Protocol Analysis Set (PPAS) Week 12	41.1 percentage of participants	60.6 percentage of participants	12.3 percentage of participants
Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale for Severity of Pruritus at Week 2, 4 and 12: Per Protocol Analysis Set (PPAS) Week 2	20.5 percentage of participants	47.6 percentage of participants	3.7 percentage of participants
Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale for Severity of Pruritus at Week 2, 4 and 12: Per Protocol Analysis Set (PPAS) Week 4	34.0 percentage of participants	63.3 percentage of participants	20.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

PSAAD is a daily participant reported symptom electronic diary. Participants 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). Participant 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.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=137 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=138 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=68 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set Change at Week 2	-1.5 units on a scale Interval -1.7 to -1.2	-2.1 units on a scale Interval -2.3 to -1.8	-0.5 units on a scale Interval -0.8 to -0.1
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set Change at Week 4	-1.8 units on a scale Interval -2.1 to -1.5	-3.0 units on a scale Interval -3.2 to -2.7	-0.7 units on a scale Interval -1.1 to -0.3
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set Change at Week 8	-2.2 units on a scale Interval -2.5 to -1.8	-3.1 units on a scale Interval -3.5 to -2.8	-1.2 units on a scale Interval -1.7 to -0.7
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set Change at Week 12	-2.2 units on a scale Interval -2.6 to -1.9	-3.2 units on a scale Interval -3.6 to -2.8	-1.1 units on a scale Interval -1.7 to -0.6

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Per-protocol analysis set included all randomized participants who received at least 1 dose of study medication and who had no major protocol violations. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

PSAAD is a daily participant reported symptom electronic diary. Participants 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). Participant 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.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=115 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=117 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=50 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set	-2.4 units on a scale Interval -2.8 to -2.1	-3.4 units on a scale Interval -3.8 to -3.0	-1.1 units on a scale Interval -1.7 to -0.5

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Participants 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. 95% CI was based on the Brookmeyer and Crowley method.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=73 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=106 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=23 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus	84.0 days Interval 56.0 to Upper limit was not evaluable since very less events were observed.	14.0 days Interval 11.0 to 29.0	92.0 days Interval 85.0 to Upper limit was not evaluable since very less events were observed.

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies the number of participants evaluable for the specified time points.

EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point 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.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=155 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=154 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8 Week 2	10.3 percentage of participants	24.0 percentage of participants	3.9 percentage of participants
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8 Week 4	27.6 percentage of participants	47.4 percentage of participants	14.5 percentage of participants
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8 Week 8	38.3 percentage of participants	57.8 percentage of participants	13.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies the number of participants evaluable for the specified time points.

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 post-inflammatory 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 sole, palms and scalp.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=155 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=154 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 2, 4 and 8 Week 2	3.9 percentage of participants	9.7 percentage of participants	0 percentage of participants
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 2, 4 and 8 Week 4	10.5 percentage of participants	27.0 percentage of participants	5.3 percentage of participants
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 2, 4 and 8 Week 8	20.3 percentage of participants	35.7 percentage of participants	6.7 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.

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 post-inflammatory 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 sole, palms and scalp.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=156 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=154 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12 Week 2	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12 Week 4	0 percentage of participants	6.6 percentage of participants	0 percentage of participants
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12 Week 8	4.6 percentage of participants	11.7 percentage of participants	0 percentage of participants
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12 Week 12	7.1 percentage of participants	13.1 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.

EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point 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.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=156 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=154 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12 Week 2	34.2 percentage of participants	55.2 percentage of participants	10.4 percentage of participants
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12 Week 4	54.6 percentage of participants	73.7 percentage of participants	21.1 percentage of participants
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12 Week 8	57.8 percentage of participants	76.6 percentage of participants	24.0 percentage of participants
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12 Week 12	57.7 percentage of participants	75.8 percentage of participants	22.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.

EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point 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.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=156 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=154 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12 Week 2	1.9 percentage of participants	5.2 percentage of participants	1.3 percentage of participants
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12 Week 4	7.9 percentage of participants	24.3 percentage of participants	3.9 percentage of participants
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12 Week 8	14.3 percentage of participants	33.1 percentage of participants	5.3 percentage of participants
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12 Week 12	18.6 percentage of participants	38.6 percentage of participants	5.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.

EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point 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.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=156 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=154 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12 Week 2	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12 Week 4	0 percentage of participants	6.6 percentage of participants	0 percentage of participants
Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12 Week 8	4.5 percentage of participants	11.7 percentage of participants	0 percentage of participants
Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12 Week 12	6.4 percentage of participants	13.1 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication.

EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on 4-point 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.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=156 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=154 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12 Change at Week 2	-9.8 units on a scale Interval -11.3 to -8.4	-14.7 units on a scale Interval -16.1 to -13.3	-4.1 units on a scale Interval -6.1 to -2.1
Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12 Change at Week 4	-14.7 units on a scale Interval -16.3 to -13.1	-19.6 units on a scale Interval -21.2 to -17.9	-6.8 units on a scale Interval -9.2 to -4.5
Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12 Change at Week 8	-16.3 units on a scale Interval -18.1 to -14.6	-21.3 units on a scale Interval -23.0 to -19.5	-7.8 units on a scale Interval -10.3 to -5.3
Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12 Change at Week 12	-16.6 units on a scale Interval -18.4 to -14.7	-22.3 units on a scale Interval -24.1 to -20.4	-8.2 units on a scale Interval -10.9 to -5.5

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication.

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 (size of participant's hand with fingers in a closed position) 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: 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 for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=156 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=154 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12 Change at Week 2	-11.8 Percentage BSA Interval -14.3 to -9.4	-18.8 Percentage BSA Interval -21.3 to -16.4	-4.0 Percentage BSA Interval -7.6 to -0.5
Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12 Change at Week 4	-20.2 Percentage BSA Interval -23.0 to -17.4	-27.0 Percentage BSA Interval -29.8 to -24.2	-8.5 Percentage BSA Interval -12.5 to -4.5
Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12 Change at Week 8	-23.2 Percentage BSA Interval -26.3 to -20.2	-31.5 Percentage BSA Interval -34.6 to -28.5	-8.9 Percentage BSA Interval -13.3 to -4.5
Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12 Change at Week 12	-25.1 Percentage BSA Interval -28.3 to -22.0	-33.4 Percentage BSA Interval -36.6 to -30.3	-11.4 Percentage BSA Interval -16.0 to -6.8

SECONDARY outcome

Timeframe: Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.

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 (size of participant's hand with fingers in a closed position) 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: 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 representing greater severity of AD.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=156 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=154 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12 Week 2	2.6 percentage of participants	5.2 percentage of participants	1.3 percentage of participants
Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12 Week 4	8.6 percentage of participants	27.6 percentage of participants	3.9 percentage of participants
Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12 Week 8	16.2 percentage of participants	33.1 percentage of participants	6.7 percentage of participants
Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12 Week 12	21.2 percentage of participants	38.6 percentage of participants	5.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=148 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=150 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=75 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12 Week 2	14.9 percentage of participants	34.0 percentage of participants	4.0 percentage of participants
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12 Week 4	34.5 percentage of participants	50.7 percentage of participants	12.9 percentage of participants
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12 Week 8	36.3 percentage of participants	54.1 percentage of participants	12.5 percentage of participants
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12 Week 12	36.6 percentage of participants	56.8 percentage of participants	16.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=148 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=150 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=75 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12 Week 2	1.4 percentage of participants	6.0 percentage of participants	0 percentage of participants
Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12 Week 4	2.8 percentage of participants	18.2 percentage of participants	2.9 percentage of participants
Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12 Week 8	12.3 percentage of participants	23.6 percentage of participants	1.4 percentage of participants
Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12 Week 12	12.4 percentage of participants	30.8 percentage of participants	4.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=154 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=153 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12 Change at Week 2	-2.1 units on a scale Interval -2.4 to -1.7	-3.1 units on a scale Interval -3.5 to -2.8	-0.8 units on a scale Interval -1.3 to -0.3
Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12 Change at Week 4	-2.5 units on a scale Interval -2.9 to -2.1	-3.7 units on a scale Interval -4.1 to -3.3	-1.0 units on a scale Interval -1.5 to -0.4
Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12 Change at Week 8	-2.8 units on a scale Interval -3.2 to -2.4	-3.8 units on a scale Interval -4.2 to -3.4	-1.3 units on a scale Interval -1.9 to -0.7
Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12 Change at Week 12	-2.9 units on a scale Interval -3.4 to -2.5	-3.7 units on a scale Interval -4.2 to -3.3	-1.6 units on a scale Interval -2.2 to -1.0

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=150 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=151 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=75 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12 Change at Week 2	-16.4 units on a scale Interval -18.7 to -14.2	-24.4 units on a scale Interval -26.7 to -22.2	-5.5 units on a scale Interval -8.7 to -2.4
Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12 Change at Week 4	-23.1 units on a scale Interval -25.8 to -20.4	-32.6 units on a scale Interval -35.3 to -29.9	-10.5 units on a scale Interval -14.4 to -6.7
Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12 Change at Week 8	-26.0 units on a scale Interval -29.1 to -23.0	-33.7 units on a scale Interval -36.7 to -30.7	-11.7 units on a scale Interval -16.0 to -7.4
Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12 Change at Week 12	-27.0 units on a scale Interval -30.2 to -23.7	-35.5 units on a scale Interval -38.7 to -32.3	-13.6 units on a scale Interval -18.3 to -9.0

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.

PSAAD is a daily participant reported symptom electronic diary. Participants 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). Participant 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.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=135 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=136 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=67 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12 Week 2	51.1 percentage of participants	68.9 percentage of participants	28.4 percentage of participants
Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12 Week 4	62.7 percentage of participants	77.3 percentage of participants	44.8 percentage of participants
Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12 Week 8	60.9 percentage of participants	69.1 percentage of participants	44.8 percentage of participants
Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12 Week 12	61.4 percentage of participants	70.3 percentage of participants	40.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=121 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=119 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=60 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12 Change at Week 2	-5.9 units on a scale Interval -6.9 to -5.0	-7.6 units on a scale Interval -8.6 to -6.7	-2.1 units on a scale Interval -3.5 to -0.8
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12 Change at Week 4	-6.8 units on a scale Interval -7.8 to -5.9	-9.6 units on a scale Interval -10.6 to -8.7	-3.5 units on a scale Interval -4.9 to -2.1
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12 Change at Week 8	-6.8 units on a scale Interval -7.9 to -5.6	-9.3 units on a scale Interval -10.5 to -8.2	-4.0 units on a scale Interval -5.6 to -2.3
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12 Change at Week 12	-7.0 units on a scale Interval -8.1 to -5.8	-9.1 units on a scale Interval -10.3 to -8.0	-4.2 units on a scale Interval -5.9 to -2.5

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=32 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=32 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=16 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12 Change at Week 2	-4.5 units on a scale Interval -5.8 to -3.2	-5.8 units on a scale Interval -7.1 to -4.5	-3.3 units on a scale Interval -5.1 to -1.4
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12 Change at Week 4	-5.3 units on a scale Interval -6.7 to -4.0	-8.2 units on a scale Interval -9.5 to -6.8	-1.8 units on a scale Interval -3.8 to 0.2
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12 Change at Week 8	-5.2 units on a scale Interval -6.9 to -3.6	-7.5 units on a scale Interval -9.2 to -5.9	-3.1 units on a scale Interval -5.6 to -0.6
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12 Change at Week 12	-6.4 units on a scale Interval -7.9 to -5.0	-7.5 units on a scale Interval -8.9 to -6.0	-3.9 units on a scale Interval -6.1 to -1.7

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=120 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=119 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=59 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12 Week 2	10.0 percentage of participants	23.5 percentage of participants	3.4 percentage of participants
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12 Week 4	15.3 percentage of participants	32.5 percentage of participants	8.5 percentage of participants
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12 Week 8	17.8 percentage of participants	35.3 percentage of participants	8.8 percentage of participants
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12 Week 12	20.2 percentage of participants	31.9 percentage of participants	12.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=31 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=31 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=16 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12 Week 2	3.2 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12 Week 4	13.3 percentage of participants	9.7 percentage of participants	0 percentage of participants
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12 Week 8	12.9 percentage of participants	12.9 percentage of participants	7.1 percentage of participants
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12 Week 12	19.4 percentage of participants	9.7 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participant who were evaluable for this measure and "Number Analyzed" signifies number of participants evaluable at specified time points.

DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=117 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=117 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=56 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12 Week 2	67.5 percentage of participants	71.8 percentage of participants	35.7 percentage of participants
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12 Week 4	72.2 percentage of participants	85.2 percentage of participants	51.8 percentage of participants
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12 Week 8	64.7 percentage of participants	82.1 percentage of participants	48.1 percentage of participants
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12 Week 12	67.2 percentage of participants	72.6 percentage of participants	43.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.

CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=30 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=31 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=16 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12 Week 2	73.3 percentage of participants	74.2 percentage of participants	56.3 percentage of participants
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12 Week 4	69.0 percentage of participants	83.9 percentage of participants	40.0 percentage of participants
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12 Week 8	66.7 percentage of participants	77.4 percentage of participants	35.7 percentage of participants
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12 Week 12	73.3 percentage of participants	83.9 percentage of participants	53.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=152 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=152 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=76 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12 Change at Week 2	-0.7 units on a scale Interval -1.0 to -0.3	-1.3 units on a scale Interval -1.6 to -0.9	-0.2 units on a scale Interval -0.7 to 0.3
Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12 Change at Week 4	-1.1 units on a scale Interval -1.6 to -0.7	-1.7 units on a scale Interval -2.1 to -1.3	0.1 units on a scale Interval -0.5 to 0.7
Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12 Change at Week 8	-1.0 units on a scale Interval -1.4 to -0.6	-2.0 units on a scale Interval -2.4 to -1.6	-0.3 units on a scale Interval -0.9 to 0.3
Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12 Change at Week 12	-1.4 units on a scale Interval -1.8 to -0.9	-1.8 units on a scale Interval -2.2 to -1.4	-0.2 units on a scale Interval -0.8 to 0.4

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=152 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=152 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=76 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Change at Week 2	-1.1 units on a scale Interval -1.5 to -0.7	-1.7 units on a scale Interval -2.0 to -1.3	-0.9 units on a scale Interval -1.5 to -0.4
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Change at Week 4	-1.4 units on a scale Interval -1.9 to -1.0	-2.2 units on a scale Interval -2.6 to -1.8	-1.0 units on a scale Interval -1.6 to -0.4
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Change at Week 8	-1.5 units on a scale Interval -1.9 to -1.0	-2.3 units on a scale Interval -2.7 to -1.8	-1.0 units on a scale Interval -1.7 to -0.4
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Change at Week 12	-1.6 units on a scale Interval -2.0 to -1.1	-2.1 units on a scale Interval -2.5 to -1.6	-1.0 units on a scale Interval -1.7 to -0.4

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=33 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=34 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=18 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Week 12	39.4 percentage of participants	48.5 percentage of participants	38.9 percentage of participants
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Week 2	48.5 percentage of participants	64.7 percentage of participants	38.9 percentage of participants
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Week 4	50.0 percentage of participants	54.5 percentage of participants	55.6 percentage of participants
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Week 8	42.4 percentage of participants	58.8 percentage of participants	22.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=22 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=20 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=9 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12 Week 2	45.5 percentage of participants	60.0 percentage of participants	22.2 percentage of participants
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12 Week 4	68.2 percentage of participants	68.4 percentage of participants	55.6 percentage of participants
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12 Week 8	57.1 percentage of participants	70.0 percentage of participants	66.7 percentage of participants
Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12 Week 12	50.0 percentage of participants	75.0 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable at the specified time points.

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=16 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=13 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=8 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Week 2	56.3 percentage of participants	46.2 percentage of participants	75.0 percentage of participants
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Week 4	56.3 percentage of participants	58.3 percentage of participants	75.0 percentage of participants
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Week 8	56.3 percentage of participants	53.8 percentage of participants	75.0 percentage of participants
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12 Week 12	43.8 percentage of participants	46.2 percentage of participants	37.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" participants evaluable for this outcome measure.

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=5 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=8 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=3 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12 Week 2	20.0 percentage of participants	75.0 percentage of participants	100.0 percentage of participants
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12 Week 4	60.0 percentage of participants	75.0 percentage of participants	66.7 percentage of participants
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12 Week 8	40.0 percentage of participants	75.0 percentage of participants	66.7 percentage of participants
Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12 Week 12	40.0 percentage of participants	75.0 percentage of participants	66.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=153 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=153 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12 Change at Week 2	-4.6 units on a scale Interval -5.5 to -3.7	-8.1 units on a scale Interval -9.0 to -7.2	-1.8 units on a scale Interval -3.1 to -0.5
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12 Change at Week 4	-6.2 units on a scale Interval -7.2 to -5.1	-10.8 units on a scale Interval -11.8 to -9.8	-2.4 units on a scale Interval -3.9 to -0.9
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12 Change at Week 8	-6.1 units on a scale Interval -7.3 to -4.9	-10.6 units on a scale Interval -11.8 to -9.5	-3.4 units on a scale Interval -5.1 to -1.7
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12 Change at Week 12	-6.8 units on a scale Interval -8.0 to -5.6	-10.6 units on a scale Interval -11.8 to -9.4	-3.7 units on a scale Interval -5.5 to -1.9

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=154 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=153 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12 Change at Week 2	-0.6 units on a scale Interval -0.8 to -0.5	-1.1 units on a scale Interval -1.2 to -0.9	-0.3 units on a scale Interval -0.5 to -0.1
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12 Change at Week 4	-0.8 units on a scale Interval -1.0 to -0.7	-1.3 units on a scale Interval -1.5 to -1.2	-0.4 units on a scale Interval -0.6 to -0.1
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12 Change at Week 8	-1.0 units on a scale Interval -1.1 to -0.8	-1.4 units on a scale Interval -1.6 to -1.2	-0.5 units on a scale Interval -0.7 to -0.2
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12 Change at Week 12	-1.0 units on a scale Interval -1.2 to -0.9	-1.5 units on a scale Interval -1.7 to -1.3	-0.5 units on a scale Interval -0.8 to -0.3

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies the number of participants evaluable for the specified time points.

Participant responded to "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=153 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=151 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=75 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12 Week 2	7.2 percentage of participants	19.2 percentage of participants	1.3 percentage of participants
Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12 Week 4	14.6 percentage of participants	31.5 percentage of participants	5.4 percentage of participants
Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12 Week 8	17.2 percentage of participants	34.4 percentage of participants	8.5 percentage of participants
Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12 Week 12	21.1 percentage of participants	36.0 percentage of participants	6.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

EQ-5D-5L: standardized participant (aged \>17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=121 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=119 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=60 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12 Change at Week 2	0.049 units on a scale Interval 0.03 to 0.068	0.084 units on a scale Interval 0.065 to 0.103	0.016 units on a scale Interval -0.011 to 0.043
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12 Change at Week 4	0.062 units on a scale Interval 0.041 to 0.084	0.092 units on a scale Interval 0.07 to 0.114	0.037 units on a scale Interval 0.007 to 0.067
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12 Change at Week 8	0.053 units on a scale Interval 0.029 to 0.077	0.097 units on a scale Interval 0.074 to 0.121	0.005 units on a scale Interval -0.029 to 0.039
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12 Change at Week 12	0.058 units on a scale Interval 0.034 to 0.083	0.078 units on a scale Interval 0.054 to 0.103	0.014 units on a scale Interval -0.021 to 0.05

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's (aged above 17 years) rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=121 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=119 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=60 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12 Change at Week 2	5.586 units on a scale Interval 3.203 to 7.969	9.697 units on a scale Interval 7.294 to 12.1	1.038 units on a scale Interval -2.361 to 4.437
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12 Change at Week 4	6.207 units on a scale Interval 3.473 to 8.94	11.931 units on a scale Interval 9.174 to 14.688	1.846 units on a scale Interval -2.005 to 5.696
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12 Change at Week 8	6.982 units on a scale Interval 3.847 to 10.117	10.740 units on a scale Interval 7.642 to 13.838	0.937 units on a scale Interval -3.528 to 5.402
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12 Change at Week 12	8.604 units on a scale Interval 5.509 to 11.699	10.409 units on a scale Interval 7.328 to 13.489	-1.035 units on a scale Interval -3.451 to 5.52

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

EQ-5D-Y: standardized participant (aged 12-17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. UK value sets (with all possible health states) was used for adolescents in the study, range from 1 to -0.594. Higher (positive) scores = better health state.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=31 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=32 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=16 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12 Change at Week 2	0.115 units on a scale Interval 0.039 to 0.191	0.209 units on a scale Interval 0.134 to 0.284	0.119 units on a scale Interval 0.009 to 0.228
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12 Change at Week 4	0.168 units on a scale Interval 0.071 to 0.265	0.278 units on a scale Interval 0.183 to 0.374	-0.006 units on a scale Interval -0.149 to 0.137
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12 Change at Week 8	0.122 units on a scale Interval 0.017 to 0.228	0.198 units on a scale Interval 0.093 to 0.304	0.118 units on a scale Interval -0.04 to 0.275
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12 Change at Week 12	0.160 units on a scale Interval 0.056 to 0.265	0.215 units on a scale Interval 0.109 to 0.322	0.153 units on a scale Interval -0.007 to 0.314

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

EQ-5D-Y is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score specifically developed and validated for use by youths age 12-17 years. EQ-5D-Y consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=32 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=32 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=16 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12 Change at Week 2	5.515 units on a scale Interval 0.318 to 10.712	14.933 units on a scale Interval 9.742 to 20.124	3.384 units on a scale Interval -4.217 to 10.985
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12 Change at Week 4	5.359 units on a scale Interval -0.339 to 11.057	15.496 units on a scale Interval 9.803 to 21.188	-1.494 units on a scale Interval -10.06 to 7.072
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12 Change at Week 8	11.828 units on a scale Interval 5.736 to 17.919	12.510 units on a scale Interval 6.345 to 18.674	3.156 units on a scale Interval -6.213 to 12.524
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12 Change at Week 12	10.347 units on a scale Interval 5.347 to 15.347	17.224 units on a scale Interval 12.151 to 22.297	4.276 units on a scale Interval -3.397 to 11.948

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

FACIT-F is a 13-item questionnaire. Participants (aged above 17 years) scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Higher the participant's response to the questions (with the exception of 2 negatively stated) greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=106 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=108 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=49 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12	2.4 units on a scale Interval 0.8 to 3.9	3.3 units on a scale Interval 1.7 to 4.8	-1.3 units on a scale Interval -3.6 to 1.0

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Peds-FACIT-F is a 13-item questionnaire for adolescents of 12-17 years of age. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Higher the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the Peds-FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=31 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=30 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=13 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12	2.2 units on a scale Interval 0.5 to 3.9	2.1 units on a scale Interval 0.3 to 3.8	1.2 units on a scale Interval -1.4 to 3.9

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Physical component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=106 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=108 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=50 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary	4.3 units on a scale Interval 3.0 to 5.6	5.2 units on a scale Interval 3.9 to 6.5	0.5 units on a scale Interval -1.4 to 2.4

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Mental component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=106 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=108 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=50 Participants Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary	1.5 units on a scale Interval -0.1 to 3.0	2.8 units on a scale Interval 1.3 to 4.3	-0.2 units on a scale Interval -2.5 to 2.0

SECONDARY outcome

Timeframe: Day 1 of Week 4: 0 hour(Pre-dose), 0.5 hours post-dose; Day 1 of Week 12: 0.5, 4 hours post-dose

Population: Analysis set included all randomized participants who received at least 1 dose of PF-04965842 and had pharmacokinetic measurements. Here, 'Number Analyzed' = participants evaluable for the specified time points.

Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ) = =1.00 nanogram per milliliter (ng/mL) to zero.

Outcome measures

Outcome measures
Measure	PF-04965842 100 mg n=142 Participants Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=144 Participants Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Plasma Concentration Versus Time Summary of PF-04965842 Week 4: 0 Hour	14.57 ng/mL Standard Deviation 65.044	58.16 ng/mL Standard Deviation 162.11	—
Plasma Concentration Versus Time Summary of PF-04965842 Week 4: 0.5 Hour post dose	485.3 ng/mL Standard Deviation 393.36	889.7 ng/mL Standard Deviation 786.96	—
Plasma Concentration Versus Time Summary of PF-04965842 Week 12: 0.5 Hour Post-dose	440.6 ng/mL Standard Deviation 373.81	933.9 ng/mL Standard Deviation 741.09	—
Plasma Concentration Versus Time Summary of PF-04965842 Week 12: 4 Hour Post-dose	273.1 ng/mL Standard Deviation 176.37	838.9 ng/mL Standard Deviation 544.29	—

Adverse Events

PF-04965842 100 mg

Serious events: 5 serious events

Other events: 65 other events

Deaths: 0 deaths

PF-04965842 200 mg

Serious events: 5 serious events

Other events: 65 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-04965842 100 mg n=156 participants at risk Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=154 participants at risk Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 participants at risk Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Eye disorders Retinal detachment	0.64% 1/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Gastrointestinal disorders Inflammatory bowel disease	0.00% 0/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.65% 1/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Gastrointestinal disorders Pancreatitis acute	0.64% 1/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Infections and infestations Appendicitis	0.64% 1/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	1.3% 1/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Infections and infestations Peritonsillitis	0.00% 0/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.65% 1/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Metabolism and nutrition disorders Dehydration	0.00% 0/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.65% 1/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Musculoskeletal and connective tissue disorders Meniscal degeneration	0.00% 0/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	1.3% 1/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Nervous system disorders Dizziness	0.64% 1/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Nervous system disorders Seizure	0.64% 1/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	1.3% 2/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	0.00% 0/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	1.3% 1/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.

Other adverse events

Other adverse events
Measure	PF-04965842 100 mg n=156 participants at risk Participants were randomized to receive a tablet of PF-04965842 100 milligram (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants 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.	PF-04965842 200 mg n=154 participants at risk Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants 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.	Placebo n=77 participants at risk Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants 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.
Gastrointestinal disorders Nausea	9.0% 14/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	20.1% 31/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	2.6% 2/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Infections and infestations Nasopharyngitis	14.7% 23/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	11.7% 18/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	10.4% 8/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Infections and infestations Upper respiratory tract infection	7.1% 11/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	7.1% 11/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	6.5% 5/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Nervous system disorders Headache	7.7% 12/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	9.7% 15/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	2.6% 2/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
Skin and subcutaneous tissue disorders Dermatitis atopic	14.1% 22/156 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	5.2% 8/154 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.	16.9% 13/77 • Baseline up to Week 16 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 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.

Additional Information

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Results disclosure agreements

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