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

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03349060
Acronym
JADE Mono-1
Enrollment
387
Registered
2017-11-21
Start date
2017-12-07
Completion date
2019-03-26
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Atopic

Keywords

atopic dermatitis, atopic eczema, eczema, JAK, janus kinase

Brief summary

B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.

Interventions

PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks

PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks

DRUGPlacebo

Placebo, administered as two tablets to be taken orally once daily for 12 weeks

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 12 years of age or older with a minimum body weight of 40 kg * Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (\>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS 4) * Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion criteria

* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study * Prior treatment with JAK inhibitors * Other active nonAD inflammatory skin diseases or conditions affecting skin * Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator * Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception

Design outcomes

Primary

MeasureTime frameDescription
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 12Baseline, Week 12IGA 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.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12Baseline, Week 12EASI 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.

Secondary

MeasureTime frameDescription
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetBaseline, Week 2, 4, 8, 12PSAAD 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.
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis SetBaseline, Week 12PSAAD 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.
Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of PruritusBaseline up to Week 12Participants 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.
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8Baseline, Week 2, 4, 8EASI 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.
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 8Baseline, Week 2, 4, 8IGA 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.
Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 2, 4, 8, 12IGA 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.
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12EASI 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.
Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12EASI 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.
Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12EASI 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.
Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12EASI 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.
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 12Baseline, Week 2, 4, 8, 12DLQI 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.
Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 124 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.
Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 2, 4, 8, 124 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.
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12SCORAD: 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.
Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12SCORAD: 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.
Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12SCORAD: 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.
Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12SCORAD: 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.
Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12PSAAD 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.
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12DLQI 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.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12CDLQI 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.
Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12DLQI 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.
Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12CDLQI 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.
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 12Baseline, Week 2, 4, 8, 12CDLQI 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.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12HADS: 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.
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12HADS: 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.
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 12Baseline, Week 2, 4, 8, 12HADS: 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.
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 12Baseline, Week 2, 4, 8, 12HADS: 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.
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 12Baseline, Week 2, 4, 8, 12HADS: 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.
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 12Baseline, Week 2, 4, 8, 12HADS: 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.
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12POEM 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.
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12Participant 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.
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 12Baseline, Week 2, 4, 8, 12Participant 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.
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12EQ-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.
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 12Baseline, Week 2, 4, 8, 12EQ-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.
Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Baseline, Week 2, 4, 8, 12EQ-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.
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 12Baseline, Week 2, 4, 8, 12EQ-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.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12Baseline, Week 12FACIT-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).
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)Baseline, Week 2, 4, 8, 12Participants 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.
Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component SummaryBaseline, Week 12SF-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.
Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component SummaryBaseline, Week 12SF-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.
Plasma Concentration Versus Time Summary of PF-04965842Day 1 of Week 4: 0 hour(Pre-dose), 0.5 hours post-dose; Day 1 of Week 12: 0.5, 4 hours post-doseConcentration 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.
Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12Baseline, Week 12Peds-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).
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)Baseline, Week 2, 4, 12Participants 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.

Countries

Australia, Canada, Czechia, Germany, Hungary, Poland, United Kingdom, United States

Participant flow

Recruitment details

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.

Pre-assignment details

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

Participants by arm

ArmCount
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.
156
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.
154
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.
77
Total387

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event997
Overall StudyLack of Efficacy102
Overall StudyLost to Follow-up211
Overall StudyMedication error,no linked adverse event001
Overall StudyOther210
Overall StudyProtocol Violation221
Overall StudyWithdrawal By Parent/Guardian010
Overall StudyWithdrawal by Subject534

Baseline characteristics

CharacteristicPF-04965842 100 mgPF-04965842 200 mgPlaceboTotal
Age, Continuous32.6 years
STANDARD_DEVIATION 15.4
33.0 years
STANDARD_DEVIATION 17.4
31.5 years
STANDARD_DEVIATION 14.4
32.5 years
STANDARD_DEVIATION 16
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants4 Participants6 Participants20 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
144 Participants149 Participants71 Participants364 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants1 Participants0 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants4 Participants1 Participants6 Participants
Race (NIH/OMB)
Asian
26 Participants26 Participants6 Participants58 Participants
Race (NIH/OMB)
Black or African American
15 Participants11 Participants6 Participants32 Participants
Race (NIH/OMB)
More than one race
1 Participants6 Participants1 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants1 Participants3 Participants
Race (NIH/OMB)
White
113 Participants104 Participants62 Participants279 Participants
Sex: Female, Male
Female
66 Participants73 Participants28 Participants167 Participants
Sex: Female, Male
Male
90 Participants81 Participants49 Participants220 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1560 / 1540 / 77
other
Total, other adverse events
65 / 15665 / 15426 / 77
serious
Total, serious adverse events
5 / 1565 / 1543 / 77

Outcome results

Primary

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12

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.

Time frame: 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.

ArmMeasureValue (NUMBER)
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 1239.7 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 1262.7 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 1211.8 percentage of participants
Comparison: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [17.4, 38.3]Cochran-Mantel-Haenszel
Comparison: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [40.5, 61.5]Cochran-Mantel-Haenszel
Primary

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

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.

Time frame: 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.

ArmMeasureValue (NUMBER)
PF-04965842 100 mgPercentage 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 1223.7 percentage of participants
PF-04965842 200 mgPercentage 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 1243.8 percentage of participants
PlaceboPercentage 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 127.9 percentage of participants
Comparison: The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.003795% CI: [6.8, 24.8]Cochran-Mantel-Haenszel
Comparison: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [26.2, 45.7]Cochran-Mantel-Haenszel
Secondary

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Change at Week 2-4.5 units on a scale
PF-04965842 100 mgChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Change at Week 4-5.3 units on a scale
PF-04965842 100 mgChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Change at Week 8-5.2 units on a scale
PF-04965842 100 mgChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Change at Week 12-6.4 units on a scale
PF-04965842 200 mgChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Change at Week 12-7.5 units on a scale
PF-04965842 200 mgChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Change at Week 2-5.8 units on a scale
PF-04965842 200 mgChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Change at Week 8-7.5 units on a scale
PF-04965842 200 mgChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Change at Week 4-8.2 units on a scale
PlaceboChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Change at Week 12-3.9 units on a scale
PlaceboChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Change at Week 4-1.8 units on a scale
PlaceboChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Change at Week 8-3.1 units on a scale
PlaceboChange From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12Change at Week 2-3.3 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.27595% CI: [-3.5, 1]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.02895% CI: [-4.8, -0.3]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.005195% CI: [-5.9, -1.1]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-8.8, -4]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.170695% CI: [-5.1, 0.9]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.004895% CI: [-7.4, -1.4]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.062995% CI: [-5.2, 0.1]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.0195% CI: [-6.2, -0.9]Mixed Models Analysis
Secondary

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Change at Week 2-5.9 units on a scale
PF-04965842 100 mgChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Change at Week 4-6.8 units on a scale
PF-04965842 100 mgChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Change at Week 8-6.8 units on a scale
PF-04965842 100 mgChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Change at Week 12-7.0 units on a scale
PF-04965842 200 mgChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Change at Week 12-9.1 units on a scale
PF-04965842 200 mgChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Change at Week 2-7.6 units on a scale
PF-04965842 200 mgChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Change at Week 8-9.3 units on a scale
PF-04965842 200 mgChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Change at Week 4-9.6 units on a scale
PlaceboChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Change at Week 12-4.2 units on a scale
PlaceboChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Change at Week 4-3.5 units on a scale
PlaceboChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Change at Week 8-4.0 units on a scale
PlaceboChange From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12Change at Week 2-2.1 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-5.4, -2.2]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-7.1, -3.9]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.000195% CI: [-5, -1.7]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-7.8, -4.5]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.007595% CI: [-4.8, -0.7]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-7.4, -3.3]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.007295% CI: [-4.8, -0.8]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-6.9, -2.9]Mixed Models Analysis
Secondary

Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12

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.

Time frame: Baseline, Week 2, 4, 8, 12

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

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Change at Week 2-9.8 units on a scale
PF-04965842 100 mgChange From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Change at Week 8-16.3 units on a scale
PF-04965842 100 mgChange From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Change at Week 12-16.6 units on a scale
PF-04965842 100 mgChange From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Change at Week 4-14.7 units on a scale
PF-04965842 200 mgChange From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Change at Week 2-14.7 units on a scale
PF-04965842 200 mgChange From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Change at Week 4-19.6 units on a scale
PF-04965842 200 mgChange From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Change at Week 8-21.3 units on a scale
PF-04965842 200 mgChange From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Change at Week 12-22.3 units on a scale
PlaceboChange From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Change at Week 8-7.8 units on a scale
PlaceboChange From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Change at Week 2-4.1 units on a scale
PlaceboChange From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Change at Week 4-6.8 units on a scale
PlaceboChange From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12Change at Week 12-8.2 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-8.2, -3.3]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-13, -8.1]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-10.7, -5]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-15.6, -9.9]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-11.6, -5.5]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-16.5, -10.4]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-11.6, -5.1]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-17.3, -10.8]Mixed Models Analysis
Secondary

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

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Change at Week 20.049 units on a scale
PF-04965842 100 mgChange From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Change at Week 40.062 units on a scale
PF-04965842 100 mgChange From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Change at Week 80.053 units on a scale
PF-04965842 100 mgChange From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Change at Week 120.058 units on a scale
PF-04965842 200 mgChange From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Change at Week 120.078 units on a scale
PF-04965842 200 mgChange From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Change at Week 20.084 units on a scale
PF-04965842 200 mgChange From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Change at Week 80.097 units on a scale
PF-04965842 200 mgChange From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Change at Week 40.092 units on a scale
PlaceboChange From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Change at Week 120.014 units on a scale
PlaceboChange From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Change at Week 40.037 units on a scale
PlaceboChange From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Change at Week 80.005 units on a scale
PlaceboChange From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12Change at Week 20.016 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.045395% CI: [0.001, 0.066]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [0.036, 0.101]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.182195% CI: [-0.012, 0.062]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.003895% CI: [0.018, 0.092]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.024195% CI: [0.006, 0.09]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [0.051, 0.134]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.046195% CI: [0.001, 0.087]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.003795% CI: [0.021, 0.107]Mixed Models Analysis
Secondary

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

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange 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 12Change at Week 25.586 units on a scale
PF-04965842 100 mgChange 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 12Change at Week 46.207 units on a scale
PF-04965842 100 mgChange 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 12Change at Week 86.982 units on a scale
PF-04965842 100 mgChange 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 12Change at Week 128.604 units on a scale
PF-04965842 200 mgChange 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 12Change at Week 1210.409 units on a scale
PF-04965842 200 mgChange 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 12Change at Week 29.697 units on a scale
PF-04965842 200 mgChange 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 12Change at Week 810.740 units on a scale
PF-04965842 200 mgChange 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 12Change at Week 411.931 units on a scale
PlaceboChange 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 12Change at Week 12-1.035 units on a scale
PlaceboChange 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 12Change at Week 41.846 units on a scale
PlaceboChange 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 12Change at Week 80.937 units on a scale
PlaceboChange 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 12Change at Week 21.038 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.031995% CI: [0.397, 8.7]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [4.496, 12.822]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.070295% CI: [-0.362, 9.084]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [5.349, 14.821]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.0395% CI: [0.589, 11.501]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.000595% CI: [4.368, 15.237]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.006795% CI: [2.119, 13.019]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.000895% CI: [3.933, 14.815]Mixed Models Analysis
Secondary

Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Change at Week 80.122 units on a scale
PF-04965842 100 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Change at Week 40.168 units on a scale
PF-04965842 100 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Change at Week 20.115 units on a scale
PF-04965842 100 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Change at Week 120.160 units on a scale
PF-04965842 200 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Change at Week 40.278 units on a scale
PF-04965842 200 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Change at Week 20.209 units on a scale
PF-04965842 200 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Change at Week 80.198 units on a scale
PF-04965842 200 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Change at Week 120.215 units on a scale
PlaceboChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Change at Week 120.153 units on a scale
PlaceboChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Change at Week 80.118 units on a scale
PlaceboChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Change at Week 20.119 units on a scale
PlaceboChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12Change at Week 4-0.006 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.956895% CI: [-0.137, 0.13]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.178295% CI: [-0.042, 0.223]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.049195% CI: [0.001, 0.347]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.001595% CI: [0.112, 0.456]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.963895% CI: [-0.185, 0.194]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.401695% CI: [-0.109, 0.27]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.942995% CI: [-0.184, 0.198]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.521295% CI: [-0.13, 0.254]Mixed Models Analysis
Secondary

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

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12Change at Week 811.828 units on a scale
PF-04965842 100 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12Change at Week 25.515 units on a scale
PF-04965842 100 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12Change at Week 1210.347 units on a scale
PF-04965842 100 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12Change at Week 45.359 units on a scale
PF-04965842 200 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12Change at Week 812.510 units on a scale
PF-04965842 200 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12Change at Week 415.496 units on a scale
PF-04965842 200 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12Change at Week 214.933 units on a scale
PF-04965842 200 mgChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12Change at Week 1217.224 units on a scale
PlaceboChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12Change at Week 124.276 units on a scale
PlaceboChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12Change at Week 23.384 units on a scale
PlaceboChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12Change at Week 4-1.494 units on a scale
PlaceboChange From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12Change at Week 83.156 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.646795% CI: [-7.095, 11.358]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.014795% CI: [2.338, 20.761]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.189495% CI: [-3.453, 17.159]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.001595% CI: [6.699, 27.281]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.126795% CI: [-2.518, 19.862]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.100995% CI: [-1.866, 20.573]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.191595% CI: [-3.107, 15.249]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.006495% CI: [3.754, 22.143]Mixed Models Analysis
Secondary

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12

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).

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 122.4 units on a scale
PF-04965842 200 mgChange From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 123.3 units on a scale
PlaceboChange From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12-1.3 units on a scale
p-value: 0.010295% CI: [0.9, 6.4]ANCOVA
p-value: 0.001395% CI: [1.8, 7.3]ANCOVA
Secondary

Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Change at Week 12-1.6 units on a scale
PF-04965842 100 mgChange From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Change at Week 2-1.1 units on a scale
PF-04965842 100 mgChange From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Change at Week 8-1.5 units on a scale
PF-04965842 100 mgChange From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Change at Week 4-1.4 units on a scale
PF-04965842 200 mgChange From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Change at Week 8-2.3 units on a scale
PF-04965842 200 mgChange From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Change at Week 12-2.1 units on a scale
PF-04965842 200 mgChange From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Change at Week 4-2.2 units on a scale
PF-04965842 200 mgChange From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Change at Week 2-1.7 units on a scale
PlaceboChange From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Change at Week 12-1.0 units on a scale
PlaceboChange From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Change at Week 4-1.0 units on a scale
PlaceboChange From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Change at Week 8-1.0 units on a scale
PlaceboChange From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12Change at Week 2-0.9 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.613495% CI: [-0.9, 0.5]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.042295% CI: [-1.4, 0]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.20595% CI: [-1.2, 0.3]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.001295% CI: [-1.9, -0.5]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.265795% CI: [-1.2, 0.3]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.001995% CI: [-2, -0.5]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.167595% CI: [-1.3, 0.2]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.008595% CI: [-1.8, -0.3]Mixed Models Analysis
Secondary

Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Change at Week 2-0.7 units on a scale
PF-04965842 100 mgChange From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Change at Week 4-1.1 units on a scale
PF-04965842 100 mgChange From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Change at Week 8-1.0 units on a scale
PF-04965842 100 mgChange From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Change at Week 12-1.4 units on a scale
PF-04965842 200 mgChange From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Change at Week 12-1.8 units on a scale
PF-04965842 200 mgChange From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Change at Week 2-1.3 units on a scale
PF-04965842 200 mgChange From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Change at Week 8-2.0 units on a scale
PF-04965842 200 mgChange From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Change at Week 4-1.7 units on a scale
PlaceboChange From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Change at Week 12-0.2 units on a scale
PlaceboChange From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Change at Week 40.1 units on a scale
PlaceboChange From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Change at Week 8-0.3 units on a scale
PlaceboChange From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12Change at Week 2-0.2 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.171895% CI: [-1.1, 0.2]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.001895% CI: [-1.7, -0.4]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.000595% CI: [-2, -0.6]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-2.5, -1.1]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.047695% CI: [-1.5, 0]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-2.4, -1]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.002895% CI: [-1.9, -0.4]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-2.3, -0.9]Mixed Models Analysis
Secondary

Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Change at Week 2-0.6 units on a scale
PF-04965842 100 mgChange From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Change at Week 4-0.8 units on a scale
PF-04965842 100 mgChange From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Change at Week 8-1.0 units on a scale
PF-04965842 100 mgChange From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Change at Week 12-1.0 units on a scale
PF-04965842 200 mgChange From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Change at Week 12-1.5 units on a scale
PF-04965842 200 mgChange From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Change at Week 2-1.1 units on a scale
PF-04965842 200 mgChange From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Change at Week 8-1.4 units on a scale
PF-04965842 200 mgChange From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Change at Week 4-1.3 units on a scale
PlaceboChange From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Change at Week 12-0.5 units on a scale
PlaceboChange From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Change at Week 4-0.4 units on a scale
PlaceboChange From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Change at Week 8-0.5 units on a scale
PlaceboChange From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Change at Week 2-0.3 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.00295% CI: [-0.6, -0.1]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-1, -0.6]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.001195% CI: [-0.7, -0.2]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-1.2, -0.7]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.00295% CI: [-0.8, -0.2]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-1.2, -0.6]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.001495% CI: [-0.8, -0.2]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-1.3, -0.6]Mixed Models Analysis
Secondary

Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Change at Week 8-6.1 units on a scale
PF-04965842 100 mgChange From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Change at Week 4-6.2 units on a scale
PF-04965842 100 mgChange From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Change at Week 2-4.6 units on a scale
PF-04965842 100 mgChange From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Change at Week 12-6.8 units on a scale
PF-04965842 200 mgChange From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Change at Week 12-10.6 units on a scale
PF-04965842 200 mgChange From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Change at Week 2-8.1 units on a scale
PF-04965842 200 mgChange From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Change at Week 4-10.8 units on a scale
PF-04965842 200 mgChange From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Change at Week 8-10.6 units on a scale
PlaceboChange From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Change at Week 2-1.8 units on a scale
PlaceboChange From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Change at Week 12-3.7 units on a scale
PlaceboChange From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Change at Week 8-3.4 units on a scale
PlaceboChange From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12Change at Week 4-2.4 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.000695% CI: [-4.4, -1.2]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-7.9, -4.7]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-5.6, -2]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-10.2, -6.6]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.009695% CI: [-4.7, -0.7]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-9.3, -5.2]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.004995% CI: [-5.2, -0.9]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-9, -4.7]Mixed Models Analysis
Secondary

Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12

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).

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 122.2 units on a scale
PF-04965842 200 mgChange From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 122.1 units on a scale
PlaceboChange From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 121.2 units on a scale
p-value: 0.524195% CI: [-2.1, 4.2]ANCOVA
p-value: 0.582195% CI: [-2.3, 4.1]ANCOVA
Secondary

Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12

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.

Time frame: Baseline, Week 2, 4, 8, 12

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

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Change at Week 2-11.8 Percentage BSA
PF-04965842 100 mgChange From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Change at Week 4-20.2 Percentage BSA
PF-04965842 100 mgChange From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Change at Week 8-23.2 Percentage BSA
PF-04965842 100 mgChange From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Change at Week 12-25.1 Percentage BSA
PF-04965842 200 mgChange From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Change at Week 12-33.4 Percentage BSA
PF-04965842 200 mgChange From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Change at Week 2-18.8 Percentage BSA
PF-04965842 200 mgChange From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Change at Week 8-31.5 Percentage BSA
PF-04965842 200 mgChange From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Change at Week 4-27.0 Percentage BSA
PlaceboChange From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Change at Week 12-11.4 Percentage BSA
PlaceboChange From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Change at Week 4-8.5 Percentage BSA
PlaceboChange From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Change at Week 8-8.9 Percentage BSA
PlaceboChange From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12Change at Week 2-4.0 Percentage BSA
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.000495% CI: [-12.1, -3.5]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-19, -10.5]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-16.6, -6.9]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-23.4, -13.6]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-19.7, -9]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-28, -17.3]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-19.3, -8.2]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-27.6, -16.5]Mixed Models Analysis
Secondary

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetChange at Week 2-1.5 units on a scale
PF-04965842 100 mgChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetChange at Week 4-1.8 units on a scale
PF-04965842 100 mgChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetChange at Week 8-2.2 units on a scale
PF-04965842 100 mgChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetChange at Week 12-2.2 units on a scale
PF-04965842 200 mgChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetChange at Week 12-3.2 units on a scale
PF-04965842 200 mgChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetChange at Week 2-2.1 units on a scale
PF-04965842 200 mgChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetChange at Week 8-3.1 units on a scale
PF-04965842 200 mgChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetChange at Week 4-3.0 units on a scale
PlaceboChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetChange at Week 12-1.1 units on a scale
PlaceboChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetChange at Week 4-0.7 units on a scale
PlaceboChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetChange at Week 8-1.2 units on a scale
PlaceboChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis SetChange at Week 2-0.5 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-1.4, -0.6]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-2, -1.2]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-1.6, -0.6]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-2.8, -1.7]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.003595% CI: [-1.5, -0.3]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-2.5, -1.3]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.00195% CI: [-1.7, -0.4]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-2.7, -1.4]Mixed Models Analysis
Secondary

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange 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
PF-04965842 200 mgChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set-3.4 units on a scale
PlaceboChange From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set-1.1 units on a scale
Comparison: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.000295% CI: [-2, -0.6]Mixed Models Analysis
Comparison: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-3, -1.6]Mixed Models Analysis
Secondary

Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Change at Week 2-16.4 units on a scale
PF-04965842 100 mgChange From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Change at Week 4-23.1 units on a scale
PF-04965842 100 mgChange From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Change at Week 8-26.0 units on a scale
PF-04965842 100 mgChange From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Change at Week 12-27.0 units on a scale
PF-04965842 200 mgChange From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Change at Week 12-35.5 units on a scale
PF-04965842 200 mgChange From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Change at Week 2-24.4 units on a scale
PF-04965842 200 mgChange From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Change at Week 8-33.7 units on a scale
PF-04965842 200 mgChange From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Change at Week 4-32.6 units on a scale
PlaceboChange From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Change at Week 12-13.6 units on a scale
PlaceboChange From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Change at Week 4-10.5 units on a scale
PlaceboChange From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Change at Week 8-11.7 units on a scale
PlaceboChange From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12Change at Week 2-5.5 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-14.8, -7]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-22.7, -15.1]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-17.3, -7.8]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-26.8, -17.3]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-19.5, -9]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-27.2, -16.7]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-19, -7.7]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-27.5, -16.3]Mixed Models Analysis
Secondary

Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Change at Week 2-2.1 units on a scale
PF-04965842 100 mgChange From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Change at Week 4-2.5 units on a scale
PF-04965842 100 mgChange From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Change at Week 8-2.8 units on a scale
PF-04965842 100 mgChange From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Change at Week 12-2.9 units on a scale
PF-04965842 200 mgChange From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Change at Week 12-3.7 units on a scale
PF-04965842 200 mgChange From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Change at Week 2-3.1 units on a scale
PF-04965842 200 mgChange From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Change at Week 8-3.8 units on a scale
PF-04965842 200 mgChange From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Change at Week 4-3.7 units on a scale
PlaceboChange From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Change at Week 12-1.6 units on a scale
PlaceboChange From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Change at Week 4-1.0 units on a scale
PlaceboChange From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Change at Week 8-1.3 units on a scale
PlaceboChange From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12Change at Week 2-0.8 units on a scale
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-1.9, -0.6]Mixed Models Analysis
Comparison: Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-3, -1.7]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-2.2, -0.9]Mixed Models Analysis
Comparison: Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-3.4, -2]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-2.3, -0.8]Mixed Models Analysis
Comparison: Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-3.2, -1.8]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: 0.000595% CI: [-2.1, -0.6]Mixed Models Analysis
Comparison: Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.p-value: <0.000195% CI: [-2.9, -1.4]Mixed Models Analysis
Secondary

Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary1.5 units on a scale
PF-04965842 200 mgChange From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary2.8 units on a scale
PlaceboChange From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary-0.2 units on a scale
p-value: 0.225695% CI: [-1, 4.4]ANCOVA
p-value: 0.027595% CI: [0.3, 5.8]ANCOVA
Secondary

Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary

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.

Time frame: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
PF-04965842 100 mgChange From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary4.3 units on a scale
PF-04965842 200 mgChange From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary5.2 units on a scale
PlaceboChange From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary0.5 units on a scale
p-value: 0.001395% CI: [1.5, 6.1]ANCOVA
p-value: <0.000195% CI: [2.4, 7]ANCOVA
Secondary

Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Week 251.1 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Week 462.7 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Week 860.9 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Week 1261.4 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Week 1270.3 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Week 268.9 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Week 869.1 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Week 477.3 percentage of participants
PlaceboPercentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Week 1240.9 percentage of participants
PlaceboPercentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Week 444.8 percentage of participants
PlaceboPercentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Week 844.8 percentage of participants
PlaceboPercentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12Week 228.4 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.002895% CI: [8.7, 35.9]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [27.1, 53.2]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.021795% CI: [2.8, 31.4]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [18.5, 45.9]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.036395% CI: [1.4, 30]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.001195% CI: [9.8, 37.7]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.00895% CI: [5.8, 34.5]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [15, 43.3]Cochran-Mantel-Haenszel
Secondary

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

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Week 414.6 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Week 817.2 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Week 27.2 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Week 1221.1 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Week 431.5 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Week 219.2 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Week 834.4 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Week 1236.0 percentage of participants
PlaceboPercentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Week 88.5 percentage of participants
PlaceboPercentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Week 21.3 percentage of participants
PlaceboPercentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Week 45.4 percentage of participants
PlaceboPercentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12Week 126.8 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.057595% CI: [0.3, 11.7]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.000295% CI: [10.7, 25.5]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.041195% CI: [1.3, 17.1]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [16.9, 35.5]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.078195% CI: [-0.1, 18]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [16.2, 36.3]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.007595% CI: [5.3, 23.2]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [19.6, 38.9]Cochran-Mantel-Haenszel
Secondary

Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Week 20 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Week 40 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Week 84.5 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Week 126.4 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Week 1213.1 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Week 20 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Week 811.7 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Week 46.6 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Week 120 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Week 40 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Week 80 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12Week 20 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.95% CI: [-3.8, 3.8]
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.95% CI: [-3.8, 3.8]
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.95% CI: [-3.9, 3.9]
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.023495% CI: [1.3, 11.7]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.060495% CI: [-0.3, 9.5]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.002295% CI: [5.5, 17.9]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.025595% CI: [1.2, 11.6]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.00195% CI: [6.7, 19.4]Cochran-Mantel-Haenszel
Secondary

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 234.2 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 454.6 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 857.8 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 1257.7 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 1275.8 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 255.2 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 876.6 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 473.7 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 1222.4 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 421.1 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 824.0 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 210.4 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [13.9, 34.1]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [34.7, 55.5]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [21.6, 45.4]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [41.2, 64.2]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [21.9, 46.3]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [41.3, 64.6]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [23.3, 47.4]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [42, 65]Cochran-Mantel-Haenszel
Secondary

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8Week 427.6 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8Week 210.3 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8Week 838.3 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8Week 447.4 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8Week 224.0 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8Week 857.8 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8Week 23.9 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8Week 813.3 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8Week 414.5 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.086995% CI: [-0.3, 13.3]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.000195% CI: [12, 28.6]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.025995% CI: [2.6, 23.6]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [21.7, 44.2]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.000195% CI: [14.2, 35.8]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [33.6, 55.6]Cochran-Mantel-Haenszel
Secondary

Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Week 21.9 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Week 47.9 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Week 814.3 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Week 1218.6 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Week 1238.6 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Week 25.2 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Week 833.1 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Week 424.3 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Week 125.3 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Week 43.9 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Week 85.3 percentage of participants
PlaceboPercentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12Week 21.3 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.728595% CI: [-3.9, 5.2]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.144895% CI: [-1.2, 9.2]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.257695% CI: [-2.6, 10.5]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.000195% CI: [12, 28.9]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.042395% CI: [1.3, 16.8]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [18.7, 37.2]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.006695% CI: [5.4, 21.2]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [24.3, 42.5]Cochran-Mantel-Haenszel
Secondary

Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 127.1 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 40 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 84.6 percentage of participants
PF-04965842 100 mgPercentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 20 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 811.7 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 1213.1 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 20 percentage of participants
PF-04965842 200 mgPercentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 46.6 percentage of participants
PlaceboPercentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 120 percentage of participants
PlaceboPercentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 40 percentage of participants
PlaceboPercentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 80 percentage of participants
PlaceboPercentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12Week 20 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.95% CI: [-3.8, 3.8]
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.95% CI: [-3.8, 3.8]
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.95% CI: [-3.9, 3.9]
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.023495% CI: [1.3, 11.7]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.059295% CI: [-0.3, 9.5]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.002295% CI: [5.5, 17.9]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.01995% CI: [1.7, 12.3]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.00195% CI: [6.7, 19.4]Cochran-Mantel-Haenszel
Secondary

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

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage 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 8Week 820.3 percentage of participants
PF-04965842 100 mgPercentage 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 8Week 410.5 percentage of participants
PF-04965842 100 mgPercentage 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 8Week 23.9 percentage of participants
PF-04965842 200 mgPercentage 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 8Week 835.7 percentage of participants
PF-04965842 200 mgPercentage 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 8Week 29.7 percentage of participants
PF-04965842 200 mgPercentage 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 8Week 427.0 percentage of participants
PlaceboPercentage 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 8Week 45.3 percentage of participants
PlaceboPercentage 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 8Week 20 percentage of participants
PlaceboPercentage 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 8Week 86.7 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.080295% CI: [-0.7, 8.5]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.004595% CI: [4, 15.7]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.188895% CI: [-1.9, 12.4]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [13, 30.5]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.007195% CI: [5.2, 22.4]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [19.8, 38.7]Cochran-Mantel-Haenszel
Secondary

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

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage 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 12Week 856.3 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 256.3 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 1243.8 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 456.3 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 853.8 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 458.3 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 246.2 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 1246.2 percentage of participants
PlaceboPercentage 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 12Week 475.0 percentage of participants
PlaceboPercentage 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 12Week 275.0 percentage of participants
PlaceboPercentage 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 12Week 1237.5 percentage of participants
PlaceboPercentage 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 12Week 875.0 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.403695% CI: [-58.4, 20.9]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.15895% CI: [-75.9, 5.3]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.51495% CI: [-53.5, 25.1]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.414995% CI: [-63.3, 23.7]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.403695% CI: [-58.4, 20.9]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.209295% CI: [-70.9, 9.6]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.598295% CI: [-29.1, 53]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.864795% CI: [-36.3, 44.7]Cochran-Mantel-Haenszel
Secondary

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

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage 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 12Week 220.0 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 460.0 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 840.0 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 1240.0 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 1275.0 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 275.0 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 875.0 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 475.0 percentage of participants
PlaceboPercentage 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 12Week 1266.7 percentage of participants
PlaceboPercentage 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 12Week 466.7 percentage of participants
PlaceboPercentage 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 12Week 866.7 percentage of participants
PlaceboPercentage 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 12Week 2100.0 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.054695% CI: [-117.5, -39.6]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.357395% CI: [-62.5, 6.7]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.921995% CI: [-55.6, 48.5]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.317395% CI: [-14.4, 63.6]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.540895% CI: [-77, 27]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.317395% CI: [-14.4, 63.6]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.540895% CI: [-77, 27]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.317395% CI: [-14.4, 63.6]Cochran-Mantel-Haenszel
Secondary

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

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage 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 12Week 248.5 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 450.0 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 842.4 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 1239.4 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 1248.5 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 264.7 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 858.8 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 454.5 percentage of participants
PlaceboPercentage 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 12Week 1238.9 percentage of participants
PlaceboPercentage 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 12Week 455.6 percentage of participants
PlaceboPercentage 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 12Week 822.2 percentage of participants
PlaceboPercentage 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 12Week 238.9 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.553995% CI: [-19.6, 37.2]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.056195% CI: [0.8, 55.1]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.74695% CI: [-33.4, 23.7]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 195% CI: [-28.3, 28.3]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.147495% CI: [-4.5, 46.2]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.012395% CI: [12.1, 62.5]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.97695% CI: [-28.5, 27.6]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.596595% CI: [-20.4, 36.1]Cochran-Mantel-Haenszel
Secondary

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

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage 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 12Week 245.5 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 468.2 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 857.1 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 1250.0 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 1275.0 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 260.0 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 870.0 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 468.4 percentage of participants
PlaceboPercentage 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 12Week 1233.3 percentage of participants
PlaceboPercentage 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 12Week 455.6 percentage of participants
PlaceboPercentage 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 12Week 866.7 percentage of participants
PlaceboPercentage 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 12Week 222.2 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.227895% CI: [-9.9, 58]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.099695% CI: [-2, 72.4]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.444995% CI: [-21.6, 50.6]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.413995% CI: [-21.6, 55.5]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.72995% CI: [-40.7, 27.4]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.658595% CI: [-27.3, 44.6]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.363895% CI: [-18.7, 55.1]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.05595% CI: [2.4, 78.5]Cochran-Mantel-Haenszel
Secondary

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)

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage 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 1241.1 percentage of participants
PF-04965842 100 mgPercentage 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 434.0 percentage of participants
PF-04965842 100 mgPercentage 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 220.5 percentage of participants
PF-04965842 200 mgPercentage 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 1260.6 percentage of participants
PF-04965842 200 mgPercentage 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 247.6 percentage of participants
PF-04965842 200 mgPercentage 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 463.3 percentage of participants
PlaceboPercentage 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 420.7 percentage of participants
PlaceboPercentage 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 23.7 percentage of participants
PlaceboPercentage 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 1212.3 percentage of participants
Comparison: Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: 0.005595% CI: [7.4, 25.2]Cochran-Mantel-Haenszel
Comparison: Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: <0.000195% CI: [33.1, 53.6]Cochran-Mantel-Haenszel
Comparison: Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: 0.113895% CI: [-3, 28]Cochran-Mantel-Haenszel
Comparison: Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: <0.000195% CI: [26.2, 57.4]Cochran-Mantel-Haenszel
Comparison: Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: <0.000195% CI: [15.3, 42.1]Cochran-Mantel-Haenszel
Comparison: Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: <0.000195% CI: [34.6, 61.1]Cochran-Mantel-Haenszel
Secondary

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)

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage 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 834.3 percentage of participants
PF-04965842 100 mgPercentage 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 432.2 percentage of participants
PF-04965842 100 mgPercentage 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 220.4 percentage of participants
PF-04965842 100 mgPercentage 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 1237.7 percentage of participants
PF-04965842 200 mgPercentage 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 859.9 percentage of participants
PF-04965842 200 mgPercentage 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 245.6 percentage of participants
PF-04965842 200 mgPercentage 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 458.8 percentage of participants
PF-04965842 200 mgPercentage 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 1257.2 percentage of participants
PlaceboPercentage 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 22.7 percentage of participants
PlaceboPercentage 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 814.4 percentage of participants
PlaceboPercentage 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 1215.3 percentage of participants
PlaceboPercentage 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 417.2 percentage of participants
Comparison: Week 2: Each complete imputed data set was analyzed using the Cochran-Mantel-Haenszel (CMH) risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: 0.000495% CI: [10.2, 25.8]Cochran-Mantel-Haenszel
Comparison: Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: <0.000195% CI: [33.6, 51.4]Cochran-Mantel-Haenszel
Comparison: Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: 0.025195% CI: [1.9, 28]Cochran-Mantel-Haenszel
Comparison: Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: <0.000195% CI: [27.8, 54.4]Cochran-Mantel-Haenszel
Comparison: Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: 0.001995% CI: [7.4, 32.7]Cochran-Mantel-Haenszel
Comparison: Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: <0.000195% CI: [32.7, 57.8]Cochran-Mantel-Haenszel
Comparison: Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: 0.000395% CI: [10.3, 34.8]Cochran-Mantel-Haenszel
Comparison: Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.p-value: <0.000195% CI: [29.6, 53.9]Cochran-Mantel-Haenszel
Secondary

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

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage 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 12Week 866.7 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 273.3 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 1273.3 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 469.0 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 877.4 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 483.9 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 274.2 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 1283.9 percentage of participants
PlaceboPercentage 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 12Week 440.0 percentage of participants
PlaceboPercentage 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 12Week 256.3 percentage of participants
PlaceboPercentage 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 12Week 1253.3 percentage of participants
PlaceboPercentage 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 12Week 835.7 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.249795% CI: [-9.1, 43.2]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.237195% CI: [-9, 43.3]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.069795% CI: [-0.8, 58.3]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.00395% CI: [16.2, 71.7]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.058395% CI: [2, 59.9]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.008595% CI: [13.2, 69.1]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.194895% CI: [-9.8, 48.5]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.029695% CI: [2.8, 58.5]Cochran-Mantel-Haenszel
Secondary

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

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Week 23.2 percentage of participants
PF-04965842 100 mgPercentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Week 413.3 percentage of participants
PF-04965842 100 mgPercentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Week 812.9 percentage of participants
PF-04965842 100 mgPercentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Week 1219.4 percentage of participants
PF-04965842 200 mgPercentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Week 129.7 percentage of participants
PF-04965842 200 mgPercentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Week 20 percentage of participants
PF-04965842 200 mgPercentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Week 812.9 percentage of participants
PF-04965842 200 mgPercentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Week 49.7 percentage of participants
PlaceboPercentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Week 120 percentage of participants
PlaceboPercentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Week 40 percentage of participants
PlaceboPercentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Week 87.1 percentage of participants
PlaceboPercentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12Week 20 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.479595% CI: [-10.3, 16.6]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.95% CI: [-12.7, 12.7]
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.145295% CI: [-3.6, 30.3]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.223295% CI: [-6.1, 25.4]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.570795% CI: [-13.7, 25.4]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.577795% CI: [-13.6, 25.1]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.074495% CI: [1, 37.5]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.223295% CI: [-6.1, 25.4]Cochran-Mantel-Haenszel
Secondary

Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Week 210.0 percentage of participants
PF-04965842 100 mgPercentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Week 415.3 percentage of participants
PF-04965842 100 mgPercentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Week 817.8 percentage of participants
PF-04965842 100 mgPercentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Week 1220.2 percentage of participants
PF-04965842 200 mgPercentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Week 1231.9 percentage of participants
PF-04965842 200 mgPercentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Week 223.5 percentage of participants
PF-04965842 200 mgPercentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Week 835.3 percentage of participants
PF-04965842 200 mgPercentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Week 432.5 percentage of participants
PlaceboPercentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Week 1212.1 percentage of participants
PlaceboPercentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Week 48.5 percentage of participants
PlaceboPercentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Week 88.8 percentage of participants
PlaceboPercentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12Week 23.4 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.123895% CI: [-0.7, 13.9]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.000895% CI: [11, 29.2]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.209195% CI: [-2.8, 16.4]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.000595% CI: [12.9, 35]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.116195% CI: [-0.9, 19.1]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.000295% CI: [15.3, 37.7]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.183795% CI: [-2.8, 19.1]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.004695% CI: [8.1, 31.6]Cochran-Mantel-Haenszel
Secondary

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

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage 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 12Week 267.5 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 472.2 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 864.7 percentage of participants
PF-04965842 100 mgPercentage 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 12Week 1267.2 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 1272.6 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 271.8 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 882.1 percentage of participants
PF-04965842 200 mgPercentage 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 12Week 485.2 percentage of participants
PlaceboPercentage 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 12Week 1243.6 percentage of participants
PlaceboPercentage 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 12Week 451.8 percentage of participants
PlaceboPercentage 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 12Week 848.1 percentage of participants
PlaceboPercentage 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 12Week 235.7 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [17.2, 46]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [21.5, 49.9]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.00995% CI: [5.2, 35.6]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [19, 47.7]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.042195% CI: [0.6, 32.4]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [18.9, 48.8]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.003595% CI: [8.2, 38.8]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.000295% CI: [13.8, 43.9]Cochran-Mantel-Haenszel
Secondary

Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 48.6 percentage of participants
PF-04965842 100 mgPercentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 1221.2 percentage of participants
PF-04965842 100 mgPercentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 816.2 percentage of participants
PF-04965842 100 mgPercentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 22.6 percentage of participants
PF-04965842 200 mgPercentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 833.1 percentage of participants
PF-04965842 200 mgPercentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 1238.6 percentage of participants
PF-04965842 200 mgPercentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 427.6 percentage of participants
PF-04965842 200 mgPercentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 25.2 percentage of participants
PlaceboPercentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 125.3 percentage of participants
PlaceboPercentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 21.3 percentage of participants
PlaceboPercentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 86.7 percentage of participants
PlaceboPercentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12Week 43.9 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.52195% CI: [-3.4, 6]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.141695% CI: [-1.3, 9.3]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.200295% CI: [-2.1, 11.2]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [15.1, 32.2]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.043495% CI: [1.3, 17.9]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [17.1, 36.2]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.001995% CI: [7.5, 24]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [24, 42.7]Cochran-Mantel-Haenszel
Secondary

Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Week 21.4 percentage of participants
PF-04965842 100 mgPercentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Week 42.8 percentage of participants
PF-04965842 100 mgPercentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Week 812.3 percentage of participants
PF-04965842 100 mgPercentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Week 1212.4 percentage of participants
PF-04965842 200 mgPercentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Week 1230.8 percentage of participants
PF-04965842 200 mgPercentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Week 26.0 percentage of participants
PF-04965842 200 mgPercentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Week 823.6 percentage of participants
PF-04965842 200 mgPercentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Week 418.2 percentage of participants
PlaceboPercentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Week 124.1 percentage of participants
PlaceboPercentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Week 42.9 percentage of participants
PlaceboPercentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Week 81.4 percentage of participants
PlaceboPercentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12Week 20 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.315195% CI: [-2.9, 5.6]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.029295% CI: [0.7, 11.3]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.940295% CI: [-5.9, 5.5]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.001995% CI: [7.3, 23.2]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.007895% CI: [4.2, 17.4]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [14.2, 30.1]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.052895% CI: [1, 15.3]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [17.6, 35.3]Cochran-Mantel-Haenszel
Secondary

Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
PF-04965842 100 mgPercentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 214.9 percentage of participants
PF-04965842 100 mgPercentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 434.5 percentage of participants
PF-04965842 100 mgPercentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 836.3 percentage of participants
PF-04965842 100 mgPercentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 1236.6 percentage of participants
PF-04965842 200 mgPercentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 1256.8 percentage of participants
PF-04965842 200 mgPercentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 234.0 percentage of participants
PF-04965842 200 mgPercentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 854.1 percentage of participants
PF-04965842 200 mgPercentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 450.7 percentage of participants
PlaceboPercentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 1216.4 percentage of participants
PlaceboPercentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 412.9 percentage of participants
PlaceboPercentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 812.5 percentage of participants
PlaceboPercentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12Week 24.0 percentage of participants
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.015195% CI: [3.3, 18.3]Cochran-Mantel-Haenszel
Comparison: Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [21, 39]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.00195% CI: [10.2, 32.3]Cochran-Mantel-Haenszel
Comparison: Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [26.6, 49.3]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.000395% CI: [12.6, 34.3]Cochran-Mantel-Haenszel
Comparison: Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [30.7, 52.7]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: 0.002695% CI: [8.1, 31.1]Cochran-Mantel-Haenszel
Comparison: Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.p-value: <0.000195% CI: [28.3, 51.7]Cochran-Mantel-Haenszel
Secondary

Plasma Concentration Versus Time Summary of PF-04965842

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04965842 100 mgPlasma Concentration Versus Time Summary of PF-04965842Week 4: 0 Hour14.57 ng/mLStandard Deviation 65.044
PF-04965842 100 mgPlasma Concentration Versus Time Summary of PF-04965842Week 4: 0.5 Hour post dose485.3 ng/mLStandard Deviation 393.36
PF-04965842 100 mgPlasma Concentration Versus Time Summary of PF-04965842Week 12: 0.5 Hour Post-dose440.6 ng/mLStandard Deviation 373.81
PF-04965842 100 mgPlasma Concentration Versus Time Summary of PF-04965842Week 12: 4 Hour Post-dose273.1 ng/mLStandard Deviation 176.37
PF-04965842 200 mgPlasma Concentration Versus Time Summary of PF-04965842Week 12: 4 Hour Post-dose838.9 ng/mLStandard Deviation 544.29
PF-04965842 200 mgPlasma Concentration Versus Time Summary of PF-04965842Week 4: 0 Hour58.16 ng/mLStandard Deviation 162.11
PF-04965842 200 mgPlasma Concentration Versus Time Summary of PF-04965842Week 12: 0.5 Hour Post-dose933.9 ng/mLStandard Deviation 741.09
PF-04965842 200 mgPlasma Concentration Versus Time Summary of PF-04965842Week 4: 0.5 Hour post dose889.7 ng/mLStandard Deviation 786.96
Secondary

Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus

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.

Time frame: 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.

ArmMeasureValue (MEDIAN)
PF-04965842 100 mgTime to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus84.0 days
PF-04965842 200 mgTime to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus14.0 days
PlaceboTime to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus92.0 days
p-value: 0.0071Log Rank
p-value: <0.0001Log Rank

Source: ClinicalTrials.gov · Data processed: May 22, 2026