Trial Outcomes & Findings for JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis (NCT NCT03796676)

Last Updated: 2022-04-13

Results Overview

The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

287 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2022-04-13

Participant Flow

A total of 287 adolescent participants were randomized to the study, and 285 adolescent participants received study treatment, including 96 participants in the placebo group, 95 participants in the abrocitinib 100 mg QD group, and 94 participants in the abrocitinib 200 mg QD group.

Participant milestones

Participant milestones
Measure	Placebo Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD Participants received two PF-04965842 100 mg tablets QD
Overall Study STARTED	96	95	94
Overall Study COMPLETED	90	92	91
Overall Study NOT COMPLETED	6	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD Participants received two PF-04965842 100 mg tablets QD
Overall Study Adverse Event	2	1	2
Overall Study Lost to Follow-up	2	1	0
Overall Study Protocol Violation	0	0	1
Overall Study Withdrawal by Subject	1	1	0
Overall Study Participant did not complete Week 16 due to COVID-19 impact	1	0	0

Baseline Characteristics

JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD	Total n=285 Participants Total of all reporting groups
Age, Continuous	14.8 Years STANDARD_DEVIATION 1.7 • n=5 Participants	15.1 Years STANDARD_DEVIATION 1.8 • n=7 Participants	14.7 Years STANDARD_DEVIATION 1.8 • n=5 Participants	14.9 Years STANDARD_DEVIATION 1.7 • n=4 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	50 Participants n=7 Participants	38 Participants n=5 Participants	140 Participants n=4 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	45 Participants n=7 Participants	56 Participants n=5 Participants	145 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	26 Participants n=7 Participants	25 Participants n=5 Participants	76 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=5 Participants	63 Participants n=7 Participants	69 Participants n=5 Participants	197 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	12 Participants n=4 Participants
Race/Ethnicity, Customized White	56 Participants n=5 Participants	52 Participants n=7 Participants	52 Participants n=5 Participants	160 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Race/Ethnicity, Customized Asian	32 Participants n=5 Participants	31 Participants n=7 Participants	31 Participants n=5 Participants	94 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Multiracial	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Not reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=89 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12	24.5 Percentage of participants Interval 15.8 to 33.2	41.6 Percentage of participants Interval 31.3 to 51.8	46.2 Percentage of participants Interval 36.1 to 56.4

PRIMARY outcome

Timeframe: Baseline to Week 12

The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=89 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12	41.5 Percentage of participants Interval 31.5 to 51.4	68.5 Percentage of participants Interval 58.9 to 78.2	72.0 Percentage of participants Interval 62.9 to 81.2

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4 and 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.

PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=92 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=88 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 Week 2	12.6 Percentage of participants Interval 6.0 to 19.3	27.2 Percentage of participants Interval 18.1 to 36.3	38.6 Percentage of participants Interval 28.5 to 48.8
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 Week 4	20.7 Percentage of participants Interval 12.4 to 28.9	31.5 Percentage of participants Interval 21.8 to 41.1	50.0 Percentage of participants Interval 39.3 to 60.7
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12 Week 12	29.8 Percentage of participants Interval 20.0 to 39.5	52.6 Percentage of participants Interval 41.4 to 63.9	55.4 Percentage of participants Interval 44.1 to 66.7

SECONDARY outcome

Timeframe: Baseline to Week 12

The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep \& Usual Activities Questions and Patient Global Impression of Severity \& Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12	-2.0 Units on a scale Interval -2.4 to -1.6	-2.5 Units on a scale Interval -2.9 to -2.1	-2.7 Units on a scale Interval -3.1 to -2.3

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4 and 8

The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=92 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 Week 2	1.1 Percentage of participants Interval 0.0 to 3.2	6.5 Percentage of participants Interval 1.5 to 11.6	12.8 Percentage of participants Interval 6.0 to 19.5
Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 Week 4	3.1 Percentage of participants Interval 0.0 to 6.6	19.6 Percentage of participants Interval 11.5 to 27.7	38.3 Percentage of participants Interval 28.5 to 48.1
Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 Week 8	16.0 Percentage of participants Interval 8.6 to 23.4	30.8 Percentage of participants Interval 21.3 to 40.3	48.9 Percentage of participants Interval 38.7 to 59.1

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4 and 8

The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=92 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 Week 2	4.4 Percentage of participants Interval 0.2 to 8.6	19.6 Percentage of participants Interval 11.5 to 27.7	25.5 Percentage of participants Interval 16.7 to 34.3
Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 Week 4	14.6 Percentage of participants Interval 7.5 to 21.6	41.3 Percentage of participants Interval 31.2 to 51.4	63.8 Percentage of participants Interval 54.1 to 73.5
Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12 Week 8	33.3 Percentage of participants Interval 23.8 to 42.9	60.4 Percentage of participants Interval 50.4 to 70.5	68.5 Percentage of participants Interval 59.0 to 78.0

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=92 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline Week 2	24.2 Percentage of participants Interval 15.4 to 33.0	55.4 Percentage of participants Interval 45.3 to 65.6	64.9 Percentage of participants Interval 55.2 to 74.5
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline Week 4	51.0 Percentage of participants Interval 41.0 to 61.0	75.0 Percentage of participants Interval 66.2 to 83.8	81.9 Percentage of participants Interval 74.1 to 89.7
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline Week 8	65.6 Percentage of participants Interval 55.9 to 75.2	85.7 Percentage of participants Interval 78.5 to 92.9	82.6 Percentage of participants Interval 74.9 to 90.4
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline Week 12	69.1 Percentage of participants Interval 59.8 to 78.5	87.6 Percentage of participants Interval 80.8 to 94.5	87.1 Percentage of participants Interval 80.3 to 93.9

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=92 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline Week 2	0 Percentage of participants Interval 0.0 to 4.0	8.7 Percentage of participants Interval 2.9 to 14.5	10.6 Percentage of participants Interval 4.4 to 16.9
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline Week 4	2.1 Percentage of participants Interval 0.0 to 4.9	17.4 Percentage of participants Interval 9.6 to 25.1	30.9 Percentage of participants Interval 21.5 to 40.2
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline Week 8	14.0 Percentage of participants Interval 6.9 to 21.0	29.7 Percentage of participants Interval 20.3 to 39.1	40.2 Percentage of participants Interval 30.2 to 50.2
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline Week 12	18.1 Percentage of participants Interval 10.3 to 25.9	41.6 Percentage of participants Interval 31.3 to 51.8	49.5 Percentage of participants Interval 39.3 to 59.6

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=92 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline Week 2	0 Percentage of participants Interval 0.0 to 4.0	1.1 Percentage of participants Interval 0.0 to 3.2	0 Percentage of participants Interval 0.0 to 3.8
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline Week 4	0 Percentage of participants Interval 0.0 to 3.8	2.2 Percentage of participants Interval 0.0 to 5.2	5.3 Percentage of participants Interval 0.8 to 9.9
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline Week 8	0 Percentage of participants Interval 0.0 to 3.9	3.3 Percentage of participants Interval 0.0 to 7.0	9.8 Percentage of participants Interval 3.7 to 15.9
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline Week 12	2.1 Percentage of participants Interval 0.0 to 5.0	2.2 Percentage of participants Interval 0.0 to 5.3	8.6 Percentage of participants Interval 2.9 to 14.3

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=92 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Percent Change From Baseline in EASI Score Week 2	-27.6 Percent change Interval -34.0 to -21.2	-51.5 Percent change Interval -57.9 to -45.1	-54.5 Percent change Interval -61.0 to -48.0
Percent Change From Baseline in EASI Score Week 4	-41.7 Percent change Interval -48.3 to -35.1	-66.1 Percent change Interval -72.7 to -59.4	-74.3 Percent change Interval -81.0 to -67.5
Percent Change From Baseline in EASI Score Week 8	-57.6 Percent change Interval -63.4 to -51.8	-72.6 Percent change Interval -78.4 to -66.8	-77.8 Percent change Interval -83.7 to -71.9
Percent Change From Baseline in EASI Score Week 12	-63.7 Percent change Interval -69.5 to -57.9	-77.3 Percent change Interval -83.1 to -71.5	-80.6 Percent change Interval -86.5 to -74.8

SECONDARY outcome

Timeframe: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15

Outcome measures

Outcome measures
Measure	Placebo n=84 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=83 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=82 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 2	1.2 Percentage of participants Interval 0.0 to 3.6	2.8 Percentage of participants Interval 0.0 to 6.7	3.9 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 3	0 Percentage of participants Interval 0.0 to 4.6	5.1 Percentage of participants Interval 0.2 to 9.9	7.7 Percentage of participants Interval 1.8 to 13.6
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 4	4.9 Percentage of participants Interval 0.2 to 9.7	11.5 Percentage of participants Interval 4.4 to 18.6	14.3 Percentage of participants Interval 6.5 to 22.1
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 5	6.9 Percentage of participants Interval 1.1 to 12.8	12.2 Percentage of participants Interval 5.1 to 19.3	18.5 Percentage of participants Interval 10.1 to 27.0
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 6	8.8 Percentage of participants Interval 2.6 to 14.9	16.0 Percentage of participants Interval 8.1 to 24.0	21.3 Percentage of participants Interval 12.3 to 30.2
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 7	10.1 Percentage of participants Interval 3.5 to 16.8	16.0 Percentage of participants Interval 8.1 to 24.0	21.3 Percentage of participants Interval 12.3 to 30.2
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 8	4.0 Percentage of participants Interval 0.0 to 8.4	17.3 Percentage of participants Interval 8.8 to 25.9	25.0 Percentage of participants Interval 15.3 to 34.7
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 9	6.0 Percentage of participants Interval 0.9 to 11.1	16.0 Percentage of participants Interval 7.7 to 24.3	25.0 Percentage of participants Interval 15.5 to 34.5
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 10	8.3 Percentage of participants Interval 2.4 to 14.2	15.6 Percentage of participants Interval 7.5 to 23.7	28.8 Percentage of participants Interval 18.8 to 38.7
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 11	7.6 Percentage of participants Interval 1.8 to 13.4	20.8 Percentage of participants Interval 11.7 to 29.8	27.0 Percentage of participants Interval 16.9 to 37.1
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 12	10.8 Percentage of participants Interval 3.7 to 17.9	22.2 Percentage of participants Interval 12.6 to 31.8	23.6 Percentage of participants Interval 13.8 to 33.4
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 13	10.0 Percentage of participants Interval 3.4 to 16.6	26.3 Percentage of participants Interval 16.6 to 35.9	31.2 Percentage of participants Interval 20.8 to 41.5
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 14	9.5 Percentage of participants Interval 3.2 to 15.8	24.7 Percentage of participants Interval 15.3 to 34.1	32.4 Percentage of participants Interval 21.8 to 43.1
Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12 Day 15	14.3 Percentage of participants Interval 6.8 to 21.8	27.7 Percentage of participants Interval 18.1 to 37.3	37.8 Percentage of participants Interval 27.3 to 48.3

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: The Full Analysis Set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants in the FAS with a baseline numeric rating score for severity of pruritus \>=4 were included in the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=93 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=90 Participants Participants received two PF-04965842 100 mg tablets QD
Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus	90.0 Days Interval 62.0 to The upper limit was not evaluable as too few events were observed.	70.0 Days Interval 30.0 to 85.0	29.0 Days Interval 15.0 to 61.0

SECONDARY outcome

Timeframe: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15

Outcome measures

Outcome measures
Measure	Placebo n=84 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=83 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=82 Participants Participants received two PF-04965842 100 mg tablets QD
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 15	-15.8 Percent change Interval -22.7 to -8.8	-30.7 Percent change Interval -37.7 to -23.7	-33.4 Percent change Interval -40.5 to -26.3
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 2	-0.9 Percent change Interval -5.5 to 3.6	-9.5 Percent change Interval -14.2 to -4.8	-5.4 Percent change Interval -10.0 to -0.7
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 3	-1.1 Percent change Interval -6.0 to 3.8	-11.3 Percent change Interval -16.2 to -6.4	-10.2 Percent change Interval -15.2 to -5.2
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 4	-5.0 Percent change Interval -10.6 to 0.5	-14.6 Percent change Interval -20.2 to -9.1	-14.7 Percent change Interval -20.3 to -9.1
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 5	-9.5 Percent change Interval -15.8 to -3.2	-16.1 Percent change Interval -22.3 to -9.9	-17.6 Percent change Interval -23.9 to -11.3
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 6	-8.7 Percent change Interval -15.2 to -2.2	-18.5 Percent change Interval -25.0 to -12.1	-18.7 Percent change Interval -25.3 to -12.1
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 7	-12.3 Percent change Interval -19.4 to -5.2	-20.0 Percent change Interval -27.1 to -12.9	-18.8 Percent change Interval -26.0 to -11.6
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 8	-10.6 Percent change Interval -17.9 to -3.3	-21.6 Percent change Interval -28.9 to -14.2	-22.7 Percent change Interval -30.2 to -15.3
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 9	-9.9 Percent change Interval -17.6 to -2.3	-20.9 Percent change Interval -28.7 to -13.2	-21.7 Percent change Interval -29.5 to -13.9
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 10	-10.8 Percent change Interval -17.8 to -3.8	-26.1 Percent change Interval -33.1 to -19.0	-28.0 Percent change Interval -35.1 to -20.8
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 11	-10.7 Percent change Interval -17.7 to -3.7	-26.5 Percent change Interval -33.5 to -19.4	-26.3 Percent change Interval -33.5 to -19.1
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 12	-11.0 Percent change Interval -18.0 to -4.0	-27.0 Percent change Interval -34.0 to -20.0	-28.9 Percent change Interval -36.1 to -21.8
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 13	-14.1 Percent change Interval -20.4 to -7.8	-25.2 Percent change Interval -31.5 to -18.8	-32.5 Percent change Interval -39.0 to -26.0
Percent Change From Baseline in PP-NRS for Severity of Pruritus Day 14	-12.0 Percent change Interval -18.1 to -5.8	-29.4 Percent change Interval -35.5 to -23.2	-35.3 Percent change Interval -41.6 to -29.0

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Change From Baseline in Percentage Body Surface Area (BSA) Week 2	-10.9 Units on a scale Interval -14.0 to -7.8	-21.0 Units on a scale Interval -24.1 to -17.9	-20.7 Units on a scale Interval -23.8 to -17.6
Change From Baseline in Percentage Body Surface Area (BSA) Week 4	-15.1 Units on a scale Interval -18.4 to -11.7	-27.7 Units on a scale Interval -31.0 to -24.3	-32.6 Units on a scale Interval -36.0 to -29.1
Change From Baseline in Percentage Body Surface Area (BSA) Week 8	-21.8 Units on a scale Interval -25.3 to -18.3	-32.6 Units on a scale Interval -36.1 to -29.1	-34.1 Units on a scale Interval -37.7 to -30.6
Change From Baseline in Percentage Body Surface Area (BSA) Week 12	-24.2 Units on a scale Interval -27.8 to -20.7	-34.4 Units on a scale Interval -38.0 to -30.8	-35.2 Units on a scale Interval -38.8 to -31.6

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Percent Change From Baseline in Percentage BSA Week 2	-20.6 Percent change Interval -26.7 to -14.5	-40.4 Percent change Interval -46.5 to -34.3	-42.2 Percent change Interval -48.3 to -36.1
Percent Change From Baseline in Percentage BSA Week 4	-29.0 Percent change Interval -36.3 to -21.8	-55.4 Percent change Interval -62.7 to -48.1	-66.0 Percent change Interval -73.4 to -58.6
Percent Change From Baseline in Percentage BSA Week 8	-46.0 Percent change Interval -52.6 to -39.3	-65.7 Percent change Interval -72.4 to -59.1	-69.5 Percent change Interval -76.3 to -62.8
Percent Change From Baseline in Percentage BSA Week 12	-53.4 Percent change Interval -60.1 to -46.7	-71.4 Percent change Interval -78.2 to -64.7	-72.6 Percent change Interval -79.3 to -65.8

SECONDARY outcome

Timeframe: Baseline to Week 12

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=89 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants Achieving Percentage BSA < 5% at Week 12	24.5 Percentage of participants Interval 15.8 to 33.2	38.2 Percentage of participants Interval 28.1 to 48.3	36.6 Percentage of participants Interval 26.8 to 46.3

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=93 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline Week 2	8.6 Percentage of participants Interval 2.9 to 14.3	22.6 Percentage of participants Interval 14.1 to 31.1	29.0 Percentage of participants Interval 19.8 to 38.3
Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline Week 4	24.0 Percentage of participants Interval 15.4 to 32.5	44.1 Percentage of participants Interval 34.0 to 54.2	64.1 Percentage of participants Interval 54.3 to 73.9
Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline Week 8	34.0 Percentage of participants Interval 24.5 to 43.6	65.6 Percentage of participants Interval 55.9 to 75.2	75.0 Percentage of participants Interval 66.2 to 83.8
Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline Week 12	37.6 Percentage of participants Interval 27.8 to 47.5	75.6 Percentage of participants Interval 66.7 to 84.4	73.9 Percentage of participants Interval 64.9 to 82.9

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=93 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline Week 2	0 Percentage of participants Interval 0.0 to 3.9	5.4 Percentage of participants Interval 0.8 to 10.0	7.5 Percentage of participants Interval 2.2 to 12.9
Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline Week 4	0 Percentage of participants Interval 0.0 to 3.8	11.8 Percentage of participants Interval 5.3 to 18.4	21.7 Percentage of participants Interval 13.3 to 30.2
Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline Week 8	8.5 Percentage of participants Interval 2.9 to 14.2	17.2 Percentage of participants Interval 9.5 to 24.9	33.7 Percentage of participants Interval 24.0 to 43.4
Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline Week 12	12.9 Percentage of participants Interval 6.1 to 19.7	36.7 Percentage of participants Interval 26.7 to 46.6	34.8 Percentage of participants Interval 25.1 to 44.5

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Change From Baseline in SCORAD Total Score Week 2	-12.3 Units on a scale Interval -15.4 to -9.2	-24.6 Units on a scale Interval -27.7 to -21.6	-25.8 Units on a scale Interval -28.9 to -22.7
Change From Baseline in SCORAD Total Score Week 4	-20.2 Units on a scale Interval -23.3 to -17.0	-32.4 Units on a scale Interval -35.5 to -29.2	-38.0 Units on a scale Interval -41.2 to -34.8
Change From Baseline in SCORAD Total Score Week 8	-26.6 Units on a scale Interval -30.0 to -23.2	-37.3 Units on a scale Interval -40.7 to -33.9	-41.5 Units on a scale Interval -45.0 to -38.0
Change From Baseline in SCORAD Total Score Week 12	-30.2 Units on a scale Interval -33.9 to -26.4	-40.9 Units on a scale Interval -44.7 to -37.2	-42.9 Units on a scale Interval -46.7 to -39.1

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Percent Change From Baseline in SCORAD Total Score Week 2	-18.7 Percent change Interval -23.1 to -14.2	-36.1 Percent change Interval -40.6 to -31.7	-38.7 Percent change Interval -43.2 to -34.2
Percent Change From Baseline in SCORAD Total Score Week 4	-30.0 Percent change Interval -34.5 to -25.5	-47.4 Percent change Interval -52.0 to -42.9	-56.9 Percent change Interval -61.6 to -52.3
Percent Change From Baseline in SCORAD Total Score Week 8	-39.9 Percent change Interval -44.9 to -34.8	-54.0 Percent change Interval -59.0 to -48.9	-62.0 Percent change Interval -67.2 to -56.9
Percent Change From Baseline in SCORAD Total Score Week 12	-44.4 Percent change Interval -50.1 to -38.8	-59.2 Percent change Interval -64.9 to -53.6	-64.3 Percent change Interval -70.1 to -58.6

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss Week 2	-0.9 Units on a scale Interval -1.4 to -0.4	-2.1 Units on a scale Interval -2.6 to -1.6	-2.6 Units on a scale Interval -3.1 to -2.1
Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss Week 4	-1.8 Units on a scale Interval -2.3 to -1.3	-2.9 Units on a scale Interval -3.3 to -2.4	-3.4 Units on a scale Interval -3.9 to -2.9
Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss Week 8	-2.2 Units on a scale Interval -2.7 to -1.7	-3.3 Units on a scale Interval -3.8 to -2.9	-3.7 Units on a scale Interval -4.2 to -3.2
Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss Week 12	-2.7 Units on a scale Interval -3.2 to -2.2	-3.5 Units on a scale Interval -3.9 to -3.0	-3.9 Units on a scale Interval -4.4 to -3.4

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss Week 2	2.6 Percent change Interval -101.2 to 106.3	65.1 Percent change Interval -39.2 to 169.4	-36.5 Percent change Interval -140.7 to 67.8
Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss Week 4	-20.0 Percent change Interval -35.2 to -4.9	-35.2 Percent change Interval -50.7 to -19.8	-53.4 Percent change Interval -69.1 to -37.8
Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss Week 8	-24.7 Percent change Interval -60.1 to 10.8	-44.2 Percent change Interval -79.9 to -8.5	-30.6 Percent change Interval -66.7 to 5.5
Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss Week 12	-39.5 Percent change Interval -77.7 to -1.3	-49.8 Percent change Interval -88.3 to -11.3	-35.2 Percent change Interval -74.1 to 3.7

SECONDARY outcome

Timeframe: Baseline to Day 88

Population: The Full Analysis Set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The analysis population included all participants in the FAS who had used corticosteroid during treatment period.

Outcome measures

Outcome measures
Measure	Placebo n=83 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=89 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=82 Participants Participants received two PF-04965842 100 mg tablets QD
Number of Days When a Corticosteroid Not Used up to Day 88	6.8 Days Interval 2.0 to 11.6	10.9 Days Interval 6.2 to 15.5	15.1 Days Interval 10.2 to 19.9

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Change From Baseline in Children's Dermatology Life Quality Index (DLQI) Week 2	-4.2 Units on a scale Interval -5.1 to -3.3	-6.1 Units on a scale Interval -7.1 to -5.2	-6.3 Units on a scale Interval -7.2 to -5.3
Change From Baseline in Children's Dermatology Life Quality Index (DLQI) Week 4	-5.4 Units on a scale Interval -6.3 to -4.5	-7.3 Units on a scale Interval -8.2 to -6.4	-7.6 Units on a scale Interval -8.6 to -6.7
Change From Baseline in Children's Dermatology Life Quality Index (DLQI) Week 8	-6.1 Units on a scale Interval -7.0 to -5.1	-8.1 Units on a scale Interval -9.1 to -7.1	-8.2 Units on a scale Interval -9.2 to -7.2
Change From Baseline in Children's Dermatology Life Quality Index (DLQI) Week 12	-6.3 Units on a scale Interval -7.4 to -5.3	-8.6 Units on a scale Interval -9.6 to -7.5	-8.7 Units on a scale Interval -9.7 to -7.6

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=92 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI Week 2	61.5 Percentage of participants Interval 51.5 to 71.5	73.6 Percentage of participants Interval 64.6 to 82.7	71.3 Percentage of participants Interval 62.1 to 80.4
Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI Week 4	73.7 Percentage of participants Interval 64.8 to 82.5	82.4 Percentage of participants Interval 74.6 to 90.2	73.4 Percentage of participants Interval 64.5 to 82.3
Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI Week 8	71.0 Percentage of participants Interval 61.7 to 80.2	85.9 Percentage of participants Interval 78.8 to 93.0	79.6 Percentage of participants Interval 71.4 to 87.8
Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI Week 12	67.7 Percentage of participants Interval 58.2 to 77.2	80.9 Percentage of participants Interval 72.7 to 89.1	78.5 Percentage of participants Interval 70.1 to 86.8

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) Week 2	-1.2 Units on a scale Interval -1.7 to -0.7	-1.6 Units on a scale Interval -2.1 to -1.1	-1.3 Units on a scale Interval -1.8 to -0.8
Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) Week 4	-1.5 Units on a scale Interval -2.1 to -1.0	-1.6 Units on a scale Interval -2.2 to -1.1	-1.9 Units on a scale Interval -2.5 to -1.3
Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) Week 8	-1.7 Units on a scale Interval -2.3 to -1.1	-2.1 Units on a scale Interval -2.7 to -1.5	-2.2 Units on a scale Interval -2.8 to -1.5
Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS) Week 12	-2.1 Units on a scale Interval -2.7 to -1.5	-2.0 Units on a scale Interval -2.6 to -1.4	-2.4 Units on a scale Interval -3.0 to -1.8

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Change From Baseline in Depression of HADS Week 2	-0.8 Units on a scale Interval -1.3 to -0.3	-1.2 Units on a scale Interval -1.7 to -0.8	-0.8 Units on a scale Interval -1.3 to -0.3
Change From Baseline in Depression of HADS Week 4	-0.8 Units on a scale Interval -1.3 to -0.3	-1.3 Units on a scale Interval -1.8 to -0.8	-1.3 Units on a scale Interval -1.8 to -0.8
Change From Baseline in Depression of HADS Week 8	-1.1 Units on a scale Interval -1.6 to -0.6	-1.4 Units on a scale Interval -1.9 to -0.9	-1.2 Units on a scale Interval -1.7 to -0.7
Change From Baseline in Depression of HADS Week 12	-1.0 Units on a scale Interval -1.5 to -0.5	-1.4 Units on a scale Interval -1.9 to -0.8	-1.2 Units on a scale Interval -1.7 to -0.6

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Week 12	-6.9 Units on a scale Interval -8.3 to -5.6	-11.1 Units on a scale Interval -12.5 to -9.7	-10.9 Units on a scale Interval -12.2 to -9.5
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Week 2	-3.4 Units on a scale Interval -4.7 to -2.1	-6.9 Units on a scale Interval -8.2 to -5.6	-8.2 Units on a scale Interval -9.5 to -6.9
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Week 4	-4.8 Units on a scale Interval -6.0 to -3.6	-9.5 Units on a scale Interval -10.7 to -8.3	-10.6 Units on a scale Interval -11.9 to -9.4
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Week 8	-5.4 Units on a scale Interval -6.7 to -4.0	-10.0 Units on a scale Interval -11.4 to -8.7	-10.6 Units on a scale Interval -12.0 to -9.3

SECONDARY outcome

Timeframe: Baseline to Week 12

The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" or "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Change From Baseline in Dermatitis Family Impact (DFI) at Week 12	-5.2 Units on a scale Interval -6.5 to -3.9	-6.7 Units on a scale Interval -7.9 to -5.4	-7.3 Units on a scale Interval -8.6 to -6.0

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Change From Baseline in Patient Global Assessment (PtGA) Week 12	-0.9 Units on a scale Interval -1.1 to -0.7	-1.4 Units on a scale Interval -1.6 to -1.2	-1.6 Units on a scale Interval -1.8 to -1.4
Change From Baseline in Patient Global Assessment (PtGA) Week 2	-0.4 Units on a scale Interval -0.6 to -0.3	-0.7 Units on a scale Interval -0.9 to -0.6	-1.0 Units on a scale Interval -1.1 to -0.8
Change From Baseline in Patient Global Assessment (PtGA) Week 4	-0.7 Units on a scale Interval -0.8 to -0.5	-0.9 Units on a scale Interval -1.1 to -0.8	-1.2 Units on a scale Interval -1.4 to -1.1
Change From Baseline in Patient Global Assessment (PtGA) Week 8	-0.8 Units on a scale Interval -1.0 to -0.6	-1.2 Units on a scale Interval -1.3 to -1.0	-1.4 Units on a scale Interval -1.6 to -1.2

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=93 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA Week 8	6.4 Percentage of participants Interval 1.4 to 11.3	22.6 Percentage of participants Interval 14.1 to 31.1	26.9 Percentage of participants Interval 17.9 to 35.9
Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA Week 12	10.6 Percentage of participants Interval 4.4 to 16.9	30.0 Percentage of participants Interval 20.5 to 39.5	36.6 Percentage of participants Interval 26.8 to 46.3
Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA Week 2	1.1 Percentage of participants Interval 0.0 to 3.2	5.4 Percentage of participants Interval 0.8 to 10.1	5.3 Percentage of participants Interval 0.8 to 9.9
Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA Week 4	4.2 Percentage of participants Interval 0.2 to 8.2	14.1 Percentage of participants Interval 7.0 to 21.2	20.2 Percentage of participants Interval 12.1 to 28.3

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8 and 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine).

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score Week 2	7.140 Units on a scale Interval 3.787 to 10.492	11.241 Units on a scale Interval 7.882 to 14.601	12.141 Units on a scale Interval 8.763 to 15.52
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score Week 4	8.784 Units on a scale Interval 5.625 to 11.943	13.222 Units on a scale Interval 10.02 to 16.423	14.677 Units on a scale Interval 11.438 to 17.917
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score Week 8	8.415 Units on a scale Interval 4.888 to 11.941	14.502 Units on a scale Interval 10.977 to 18.028	14.653 Units on a scale Interval 11.076 to 18.231
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score Week 12	9.944 Units on a scale Interval 6.373 to 13.515	14.226 Units on a scale Interval 10.624 to 17.828	15.756 Units on a scale Interval 12.153 to 19.36

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12	2.5 Units on a scale Interval 1.1 to 3.9	4.5 Units on a scale Interval 3.0 to 5.9	4.3 Units on a scale Interval 2.9 to 5.7

SECONDARY outcome

Timeframe: 16 weeks

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Number of Participants With Treatment Emergent Adverse Events (TEAEs) All-causality TEAEs	50 Participants	54 Participants	59 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Treatment-related TEAEs	16 Participants	20 Participants	31 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Number of Participants With Serious Adverse Events (SAEs) All-causality SAEs	2 Participants	0 Participants	1 Participants
Number of Participants With Serious Adverse Events (SAEs) Treatment-related SAEs	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 Participants Participants received two PF-04965842 100 mg tablets QD
Number of Participants Who Discontinued From the Study Due to TEAEs All-causality TEAEs	2 Participants	1 Participants	2 Participants
Number of Participants Who Discontinued From the Study Due to TEAEs Treatment-related TEAEs	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 16 weeks

Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) LDL Cholesterol (mg/dL) >1.2*ULN	2 Participants	2 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Triglycerides (mg/dL) >1.3*ULN	17 Participants	11 Participants	13 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Sodium (mEq/L) <0.95*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Sodium (mEq/L) >1.05*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Potassium (mEq/L) <0.9*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Lymphocytes (10^3/mm^3) >1.2*ULN	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Lymphocytes/Leukocytes (%) <0.8*LLN	6 Participants	4 Participants	6 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Chloride (mEq/L) >1.1*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Calcium (mg/dL) <0.9*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Bicarbonate (mEq/L) >1.1*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine pH (Scalar) <4.5	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine pH (Scalar) >8	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Glucose >=1	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Hyaline Casts (/LPF) >1	2 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Hemoglobin (g/dL) <0.8*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Hematocrit (%) <0.8*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Erythrocytes (10^6/mm^3) <0.8*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Reticulocytes (10^3/mm^3) <0.5*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Reticulocytes (10^3/mm^3) >1.5*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ery. Mean Corpuscular Volume (10^-15L) <0.9*LLN	1 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ery. Mean Corpuscular Volume (10^-15L) >1.1*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9*LLN	1 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Platelets (10^3/mm^3) <0.5*LLN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Platelets (10^3/mm^3) >1.75*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Reticulocytes/Erythrocytes (%) <0.5*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Reticulocytes/Erythrocytes (%) >1.5*ULN	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Leukocytes (10^3/mm^3) <0.6*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Leukocytes (10^3/mm^3) >1.5*ULN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Lymphocytes (10^3/mm^3) <0.8*LLN	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Lymphocytes/Leukocytes (%) >1.2*ULN	1 Participants	1 Participants	4 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Neutrophils (10^3/mm^3) <0.8*LLN	1 Participants	2 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Neutrophils (10^3/mm^3) >1.2*ULN	6 Participants	5 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Neutrophils/Leukocytes (%) <0.8*LLN	5 Participants	3 Participants	7 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Neutrophils/Leukocytes (%) >1.2*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Basophils (10^3/mm^3) >1.2*ULN	3 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Basophils/Leukocytes (%) >1.2*ULN	35 Participants	24 Participants	27 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Eosinophils (10^3/mm^3) >1.2*ULN	63 Participants	55 Participants	39 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Eosinophils/Leukocytes (%) >1.2*ULN	61 Participants	62 Participants	47 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Monocytes (10^3/mm^3) >1.2*ULN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Monocytes/Leukocytes (%) >1.2*ULN	7 Participants	11 Participants	6 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Activated Partial Thromboplastin Time (sec) >1.1*ULN	2 Participants	4 Participants	4 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Prothrombin Time (sec) >1.1*ULN	4 Participants	6 Participants	8 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Prothrombin Intl.Normalized Ratio >1.1*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Bilirubin (mg/dL) >1.5*ULN	1 Participants	4 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Direct Bilirubin (mg/dL) >1.5*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Indirect Bilirubin (mg/dL) >1.5*ULN	1 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Aspartate Aminotransferase (U/L) >3.0*ULN	1 Participants	1 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Alanine Aminotransferase (U/L) >3.0*ULN	0 Participants	3 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Gamma Glutamyl Transferase (U/L) >3.0*ULN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Lactate Dehydrogenase (U/L) >3.0*ULN	0 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Alkaline Phosphatase (U/L) >3.0*ULN	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Protein (g/dL) <0.8*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Protein (g/dL) >1.2*ULN	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Albumin (g/dL) <0.8*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Albumin (g/dL) >1.2*ULN	0 Participants	0 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urea Nitrogen (mg/dL) >1.3*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Creatinine (mg/dL) >1.3*ULN	3 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urate (mg/dL) >1.2*ULN	2 Participants	4 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Potassium (mEq/L) >1.1*ULN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Chloride (mEq/L) <0.9*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Calcium (mg/dL) >1.1*ULN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Bicarbonate (mEq/L) <0.9*LLN	1 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Glucose (mg/dL) <0.6*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Glucose (mg/dL) >1.5*ULN	0 Participants	2 Participants	3 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Creatine Kinase (U/L) >2.0*ULN	5 Participants	7 Participants	12 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Cholesterol (mg/dL)>1.3*ULN	2 Participants	2 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) HDL Cholesterol (mg/dL) <0.8*LLN	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Specific Gravity (scalar) <1.003	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Specific Gravity (scalar) >1.030	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Ketones >=1	8 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Protein >=1	4 Participants	5 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Hemoglobin >=1	20 Participants	19 Participants	15 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Nitrite >=1	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Leukocyte Esterase >=1	7 Participants	14 Participants	17 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Erythrocytes (/HPF) >=20	8 Participants	7 Participants	5 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Leukocytes (/HPF) >=20	0 Participants	2 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Granular Casts (/LPF) >1	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urine Bacteria >20	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 16 weeks

A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to \>500 ms or \>60 ms change from screening ECG); data are presented below.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria QTcF Interval, Single Beat (msec) Value >500	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria QTcF Interval, Single Beat (msec) Change From Screening >60	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 16 weeks

Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes.

Outcome measures

Outcome measures
Measure	Placebo n=96 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=93 Participants Participants received two PF-04965842 100 mg tablets QD
Categorization of Vital Signs Data Meeting Prespecified Criteria Pulse Rate Value >120 bpm	0 Participants	0 Participants	0 Participants
Categorization of Vital Signs Data Meeting Prespecified Criteria Diastolic Blood Pressure Value <50mmHg	3 Participants	1 Participants	9 Participants
Categorization of Vital Signs Data Meeting Prespecified Criteria Diastolic Blood Pressure Increase From Baseline >= 20mmHg	3 Participants	6 Participants	6 Participants
Categorization of Vital Signs Data Meeting Prespecified Criteria Diastolic Blood Pressure Decrease From Baseline >= 20mmHg	3 Participants	4 Participants	8 Participants
Categorization of Vital Signs Data Meeting Prespecified Criteria Pulse Rate Value <40 bpm	0 Participants	0 Participants	0 Participants
Categorization of Vital Signs Data Meeting Prespecified Criteria Systolic Blood Pressure Value <90mmHg	4 Participants	7 Participants	4 Participants
Categorization of Vital Signs Data Meeting Prespecified Criteria Systolic Blood Pressure Increase From Baseline >=30mmHg	2 Participants	1 Participants	2 Participants
Categorization of Vital Signs Data Meeting Prespecified Criteria Systolic Blood Pressure Decrease From Baseline >=30mmHg	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 4 weeks post-vaccination with Tdap (Week 12)

Population: The immunogenicity sub-study analysis set included all participants who had completed 8 weeks of treatment and received Tdap vaccination. Number of Participants Analyzed refers to the number of participants evaluable in the analysis set at the specified visit.

The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to \<18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=8 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=4 Participants Participants received two PF-04965842 100 mg tablets QD
Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination Filamentous Hemagglutinin IgG	15.19 Ratio Interval 4.89 to 47.16	11.48 Ratio Interval 2.65 to 49.69	22.77 Ratio Interval 7.26 to 71.45
Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination Pertussis Toxin IgG	6.94 Ratio Interval 1.95 to 24.71	10.17 Ratio Interval 4.71 to 21.94	33.16 Ratio Interval 5.04 to 218.38
Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination Diphtheria IgG Antibody	14.00 Ratio Interval 6.32 to 30.99	6.51 Ratio Interval 2.31 to 18.34	34.61 Ratio Interval 6.96 to 172.06
Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination Fimbriae 2/3 IgG	1.93 Ratio Interval 0.79 to 4.73	1.11 Ratio Interval 0.85 to 1.46	1.47 Ratio Interval 0.61 to 3.5
Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination Pertactin IgG	54.03 Ratio Interval 14.67 to 199.03	15.60 Ratio Interval 5.77 to 42.14	60.18 Ratio Interval 12.79 to 283.08
Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination Tetanus Toxoid IGG AB	8.36 Ratio Interval 1.62 to 43.18	16.26 Ratio Interval 3.52 to 75.11	48.41 Ratio Interval 9.01 to 260.09

SECONDARY outcome

Timeframe: 2 hours pre-dose at Week 8

Population: The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Samples from site 1173 were excluded from the analysis.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=62 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD Participants received two PF-04965842 100 mg tablets QD
Plasma PF-04965842 Concentration at Week 8	7.882 ng/mL Standard Deviation 26.350	32.33 ng/mL Standard Deviation 76.506	—

SECONDARY outcome

Timeframe: 2 hours post-dose at Week 12

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=50 Participants Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD Participants received two PF-04965842 100 mg tablets QD
Plasma PF-04965842 Concentration at Week 12	486.6 ng/mL Standard Deviation 403.69	1271 ng/mL Standard Deviation 1000.4	—

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

PF-04965842 100mg QD

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

PF-04965842 200mg QD

Serious events: 1 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=96 participants at risk Participants received two PF-04965842-matching placebo tablets QD	PF-04965842 100mg QD n=95 participants at risk Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD	PF-04965842 200mg QD n=94 participants at risk Participants received two PF-04965842 100 mg tablets QD
Psychiatric disorders Anxiety	0.00% 0/96 • 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/95 • 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	1.1% 1/94 • Number of events 1 • 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Angioedema	1.0% 1/96 • Number of events 1 • 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/95 • 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/94 • 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Dermatitis stopic	1.0% 1/96 • Number of events 1 • 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/95 • 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/94 • 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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.
Publication restrictions are in place

Restriction type: OTHER