Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

Measure	Time frame	Description
Percentage of Participants With Loss of Response: Double-blind (DB) Period	From Day 1 of up to Week 40 of double blind period	Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. EASI total score range from 0.0 to 72.0, with higher scores representing greater severity of AD. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores = more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate and 4 = severe.
Time to Loss of Response: Double-blind Period	From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window was extended +/- 45 Days due to COVID 19)	Time (in days) to loss of response based on achieving IGA \>=2 was measured from date of first dose of randomized treatment until last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) and based on EASI, loss of at least 50% of EASI response at Week 12 and IGA score of 2 or higher. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling with scores 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. EASI composite score evaluates degree of erythema, induration/papulation, excoriation, and lichenification.

Measure	Time frame	Description
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) was scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\] and lower limbs \[l\] \[including buttocks\]) 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); where A = area score. 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 (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). 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 (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). 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 (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.
Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated worse disease status.
Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	4 body regions evaluated: head and neck, upper limbs, trunk (including axillae, groin/genitals), lower limbs (including buttocks) excluding scalp, palms, soles. BSA calculated by handprint method. Number (No) of handprints (size of participant's hand with fingers in closed position) fitting in affected area of a body region was estimated. Maximum No of handprints were 10, 20, 30, 40 for head and neck, upper limbs, trunk, and lower limbs respectively. Surface area (SA) of body region equivalent to 1 handprint: 1 handprint=10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. %Change BSA for a body region was calculated as=total No of handprints in a body region\* %SA equivalent to 1 handprint. %BSA for an individual: arithmetic mean of %BSA of all 4 body regions, ranged from 0-100%, higher values=greater AD severity.
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores added to give B (0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.
Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region-head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.
Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.
Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.
Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12	IGA assessed severity of AD on a 5-point scale (0-4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions.
Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12	EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.
Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period	From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window +/- 7 Days)	Time (in days) to loss of response based on achieving IGA \>=2 (for the first time) as measured from date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue). IGA assesses severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions.
Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12	4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) 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 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. Overall % BSA for an individual % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.
Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.
Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.
Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12	SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7\*B/2+C; range (0-103); higher values=worse outcome.
Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	Participant responded to the following question: Overall, how would you describe your Atopic Dermatitis right now? on a 5-point scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	DLQI was a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were 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) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	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 (range 0 to 3) where, 0 = not at all , 1 = only a little, 2 = quite a lot, 3 = very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give CDLQI total score range 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) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, 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-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.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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-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) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	POEM was 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 scored as following: no days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3 and, every day = 4. The total POEM score ranges from 0 to 28, where higher score indicated greater severity.
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	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 \[darker or lighter\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participants 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.
Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12	Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated greater severity.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Baseline, Weeks 12, 16, 28, 40 and 52	IGA assessed severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep dark red lesions.

Arm	Count
PF-04965842 200 mg OL to Placebo DB Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	267
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	265
PF-04965842 200 mg OL to PF-04965842 200 mg DB Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study.	266
Total	798

Period	Reason	FG000	FG001	FG002	FG003	FG004
Double-blind Treatment Period (40 Weeks)	Adverse Event	0	6	7	19	0
Double-blind Treatment Period (40 Weeks)	Lost to Follow-up	0	0	2	3	0
Double-blind Treatment Period (40 Weeks)	Other	0	0	1	1	0
Double-blind Treatment Period (40 Weeks)	Protocol Violation	0	1	5	2	0
Double-blind Treatment Period (40 Weeks)	Withdrawal By Parent/Guardian	0	0	1	0	0
Double-blind Treatment Period (40 Weeks)	Withdrawal by Subject	0	9	6	10	0
Open-label (OL) Run-in Period (12 Weeks)	Adverse Event	48	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks)	Death	1	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks)	Lack of Efficacy	315	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks)	Lost to Follow-up	13	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks)	Medication Error Without Associated Adverse Event	1	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks)	Other	4	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks)	Protocol Violation	11	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks)	Randomized but not treated	2	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks)	Withdrawal By Parent/Guardian	2	0	0	0	0
Open-label (OL) Run-in Period (12 Weeks)	Withdrawal by Subject	40	0	0	0	0
Open-label Rescue Period (12 Weeks)	Adverse Event	0	0	0	0	9
Open-label Rescue Period (12 Weeks)	Lost to Follow-up	0	0	0	0	1
Open-label Rescue Period (12 Weeks)	Other	0	0	0	0	1
Open-label Rescue Period (12 Weeks)	Withdrawal by Subject	0	0	0	0	9

Characteristic	PF-04965842 200 mg OL to Placebo DB	PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	PF-04965842 200 mg OL to PF-04965842 200 mg DB	Total
Age, Customized <18 years	49 Participants	49 Participants	47 Participants	145 Participants
Age, Customized >=65 years	8 Participants	10 Participants	12 Participants	30 Participants
Age, Customized Between 18 and 65 years	210 Participants	206 Participants	207 Participants	623 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	65 Participants	62 Participants	52 Participants	179 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	200 Participants	203 Participants	214 Participants	617 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants	0 Participants	0 Participants	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants	2 Participants	1 Participants	7 Participants
Race (NIH/OMB) Asian	38 Participants	41 Participants	45 Participants	124 Participants
Race (NIH/OMB) Black or African American	14 Participants	9 Participants	10 Participants	33 Participants
Race (NIH/OMB) More than one race	2 Participants	3 Participants	5 Participants	10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	2 Participants	1 Participants	3 Participants
Race (NIH/OMB) White	209 Participants	208 Participants	204 Participants	621 Participants
Sex: Female, Male Female	126 Participants	117 Participants	116 Participants	359 Participants
Sex: Female, Male Male	141 Participants	148 Participants	150 Participants	439 Participants

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	1 / 1,233	0 / 267	0 / 265	0 / 266	0 / 351
other Total, other adverse events	482 / 1,233	158 / 267	130 / 265	152 / 266	75 / 351
serious Total, serious adverse events	20 / 1,233	3 / 267	9 / 265	14 / 266	4 / 351

Primary

Percentage of Participants With Loss of Response: Double-blind (DB) Period

Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. EASI total score range from 0.0 to 72.0, with higher scores representing greater severity of AD. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores = more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate and 4 = severe.

Time frame: From Day 1 of up to Week 40 of double blind period

Population: Full analysis set-randomized (FAS-RA) included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment.

Arm	Measure	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With Loss of Response: Double-blind (DB) Period	77.5 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With Loss of Response: Double-blind (DB) Period	39.6 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With Loss of Response: Double-blind (DB) Period	16.5 percentage of participants

Primary

Time to Loss of Response: Double-blind Period

Time (in days) to loss of response based on achieving IGA \>=2 was measured from date of first dose of randomized treatment until last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) and based on EASI, loss of at least 50% of EASI response at Week 12 and IGA score of 2 or higher. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling with scores 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. EASI composite score evaluates degree of erythema, induration/papulation, excoriation, and lichenification.

Time frame: From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window was extended +/- 45 Days due to COVID 19)

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment. Here 'Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

Arm	Measure	Value (MEDIAN)
PF-04965842 200 mg OL to Placebo DB	Time to Loss of Response: Double-blind Period	28.0 days
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Time to Loss of Response: Double-blind Period	323.0 days
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Time to Loss of Response: Double-blind Period	NA days

Comparison: A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% confidence interval (CI).p-value: <0.000195% CI: [0.211, 0.341]Log Rank

Comparison: A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.p-value: <0.000195% CI: [0.07, 0.136]Log Rank

Comparison: A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.p-value: <0.000195% CI: [0.255, 0.516]Log Rank

Secondary

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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 (range 0 to 3) where, 0 = not at all , 1 = only a little, 2 = quite a lot, 3 = very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give CDLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for adolescents, aged 12-17 years.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	2.1 units on a scale	95% Confidence Interval 0.3
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	1.5 units on a scale	95% Confidence Interval -0.2
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-9.8 units on a scale	95% Confidence Interval -10.6
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	5.9 units on a scale	95% Confidence Interval 4.4
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	2.3 units on a scale	95% Confidence Interval 0.3
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	1.6 units on a scale	95% Confidence Interval 0.6
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-9.2 units on a scale	95% Confidence Interval -10
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	1.7 units on a scale	95% Confidence Interval 0.5
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	1.7 units on a scale	95% Confidence Interval 0.7
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	1.3 units on a scale	95% Confidence Interval 0
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	0.4 units on a scale	95% Confidence Interval -0.6
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	0.0 units on a scale	95% Confidence Interval -0.9
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-9.3 units on a scale	95% Confidence Interval -10.2
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	0.4 units on a scale	95% Confidence Interval -0.5
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	-0.3 units on a scale	95% Confidence Interval -1.4

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.333995% CI: [-0.6, 1.8]Mixed Models Analysis

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.465395% CI: [-0.8, 1.7]Mixed Models Analysis

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-1.3, 1.1]

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-6.2, -2.3]Mixed Models Analysis

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-8.2, -4.3]Mixed Models Analysis

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-3.6, -0.3]

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.908395% CI: [-1.8, 2.1]Mixed Models Analysis

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.243995% CI: [-3, 0.8]Mixed Models Analysis

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-2.6, 0.1]

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.740595% CI: [-2.4, 1.7]Mixed Models Analysis

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.04195% CI: [-4.1, -0.1]Mixed Models Analysis

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-3.1, -0.4]

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.402695% CI: [-3.5, 1.4]Mixed Models Analysis

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.094495% CI: [-4.2, 0.3]Mixed Models Analysis

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-2.5, 0.7]

Secondary

Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period

DLQI was a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were 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, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for adults, aged 18 years and above.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	4.4 units on a scale	95% Confidence Interval 3
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	6.1 units on a scale	95% Confidence Interval 5
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-13.5 units on a scale	95% Confidence Interval -13.9
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	6.9 units on a scale	95% Confidence Interval 6.1
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	3.6 units on a scale	95% Confidence Interval 2.1
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	2.1 units on a scale	95% Confidence Interval 1.4
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-13.4 units on a scale	95% Confidence Interval -13.8
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	1.9 units on a scale	95% Confidence Interval 1.2
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	2.5 units on a scale	95% Confidence Interval 1.7
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	2.8 units on a scale	95% Confidence Interval 2
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	0.9 units on a scale	95% Confidence Interval 0.2
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	1.1 units on a scale	95% Confidence Interval 0.5
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-13.5 units on a scale	95% Confidence Interval -14
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	0.9 units on a scale	95% Confidence Interval 0.3
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	0.4 units on a scale	95% Confidence Interval -0.2

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.737395% CI: [-0.5, 0.7]Mixed Models Analysis

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.809295% CI: [-0.7, 0.5]Mixed Models Analysis

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.8, 0.4]

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-6.1, -4]Mixed Models Analysis

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-7.6, -5.5]Mixed Models Analysis

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-2.4, -0.6]

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-5.3, -2.7]Mixed Models Analysis

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-6.4, -3.9]Mixed Models Analysis

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-2.1, -0.3]

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.01595% CI: [-3.5, -0.4]Mixed Models Analysis

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-4.7, -1.7]Mixed Models Analysis

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-2.3, -0.3]

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.361695% CI: [-2.4, 0.9]Mixed Models Analysis

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.001295% CI: [-4.3, -1.1]Mixed Models Analysis

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-3, -0.8]

Secondary

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, 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-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, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	1.0 units on a scale	95% Confidence Interval 0.4
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	1.0 units on a scale	95% Confidence Interval 0.5
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-2.7 units on a scale	95% Confidence Interval -3
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	1.4 units on a scale	95% Confidence Interval 1
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	0.8 units on a scale	95% Confidence Interval 0.2
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	0.4 units on a scale	95% Confidence Interval 0.1
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-2.6 units on a scale	95% Confidence Interval -2.9
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	0.3 units on a scale	95% Confidence Interval 0
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	0.4 units on a scale	95% Confidence Interval 0.1
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	0.4 units on a scale	95% Confidence Interval 0.1
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	0.2 units on a scale	95% Confidence Interval -0.1
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	0.1 units on a scale	95% Confidence Interval -0.3
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-2.6 units on a scale	95% Confidence Interval -2.9
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	0.1 units on a scale	95% Confidence Interval -0.2
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	0.0 units on a scale	95% Confidence Interval -0.3

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.755695% CI: [-0.4, 0.6]Mixed Models Analysis

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.748495% CI: [-0.4, 0.6]Mixed Models Analysis

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.5, 0.5]

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-1.6, -0.6]Mixed Models Analysis

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-1.9, -0.9]Mixed Models Analysis

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.7, 0.1]

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.024295% CI: [-1.2, -0.1]Mixed Models Analysis

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.001295% CI: [-1.4, -0.4]Mixed Models Analysis

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.6, 0.1]

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.12495% CI: [-1.3, 0.2]Mixed Models Analysis

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.010795% CI: [-1.6, -0.2]Mixed Models Analysis

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.8, 0.1]

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.313995% CI: [-1.1, 0.3]Mixed Models Analysis

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.085395% CI: [-1.3, 0.1]Mixed Models Analysis

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.7, 0.2]

Secondary

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period

HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, 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-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, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-2.0 units on a scale	95% Confidence Interval -2.3
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	0.8 units on a scale	95% Confidence Interval 0.2
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	0.7 units on a scale	95% Confidence Interval 0.2
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	0.4 units on a scale	95% Confidence Interval -0.1
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	1.4 units on a scale	95% Confidence Interval 1
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	0.3 units on a scale	95% Confidence Interval 0
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-1.6 units on a scale	95% Confidence Interval -1.9
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	0.0 units on a scale	95% Confidence Interval -0.3
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	-0.1 units on a scale	95% Confidence Interval -0.4
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	-0.1 units on a scale	95% Confidence Interval -0.4
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	0.1 units on a scale	95% Confidence Interval -0.2
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	0.2 units on a scale	95% Confidence Interval -0.1
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-1.7 units on a scale	95% Confidence Interval -2
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	0.1 units on a scale	95% Confidence Interval -0.2
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	0.0 units on a scale	95% Confidence Interval -0.2

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.067495% CI: [0, 0.8]Mixed Models Analysis

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.143795% CI: [-0.1, 0.7]Mixed Models Analysis

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.5, 0.3]

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-1.8, -0.9]Mixed Models Analysis

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.4, 0.4]

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.113695% CI: [-1, 0.1]Mixed Models Analysis

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.027695% CI: [-1.1, -0.1]Mixed Models Analysis

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.5, 0.2]

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.010895% CI: [-1.5, -0.2]Mixed Models Analysis

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.067795% CI: [-1.3, 0]Mixed Models Analysis

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.2, 0.7]

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.13295% CI: [-1.1, 0.1]Mixed Models Analysis

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.297595% CI: [-0.9, 0.3]Mixed Models Analysis

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.2, 0.6]

Secondary

Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period

POEM was 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 scored as following: no days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3 and, every day = 4. The total POEM score ranges from 0 to 28, where higher score indicated greater severity.

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	7.4 units on a scale	95% Confidence Interval 5.8
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	8.3 units on a scale	95% Confidence Interval 6.9
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-15.4 units on a scale	95% Confidence Interval -16
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	9.8 units on a scale	95% Confidence Interval 8.9
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	7.3 units on a scale	95% Confidence Interval 5.4
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	3.7 units on a scale	95% Confidence Interval 2.8
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-15.8 units on a scale	95% Confidence Interval -16.4
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	3.7 units on a scale	95% Confidence Interval 3
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	4.8 units on a scale	95% Confidence Interval 3.9
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	4.9 units on a scale	95% Confidence Interval 3.8
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	2.2 units on a scale	95% Confidence Interval 1.3
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	1.9 units on a scale	95% Confidence Interval 1.1
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-15.4 units on a scale	95% Confidence Interval -16
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	1.6 units on a scale	95% Confidence Interval 0.8
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	0.6 units on a scale	95% Confidence Interval -0.1

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.353195% CI: [-1.3, 0.4]Mixed Models Analysis

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.928295% CI: [-0.8, 0.9]Mixed Models Analysis

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.4, 1.3]

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-7.3, -5]Mixed Models Analysis

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-10.3, -8.1]Mixed Models Analysis

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-4, -2.1]

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-6.2, -2.9]Mixed Models Analysis

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-8.3, -5.1]Mixed Models Analysis

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-3.3, -0.9]

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.008295% CI: [-4.5, -0.7]Mixed Models Analysis

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-7.4, -3.6]Mixed Models Analysis

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-4.2, -1.6]

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.031395% CI: [-4.5, -0.2]Mixed Models Analysis

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-7.1, -3]Mixed Models Analysis

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-4.1, -1.3]

Secondary

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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 \[darker or lighter\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participants 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, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	2.0 units on a scale	95% Confidence Interval 1.7
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	2.3 units on a scale	95% Confidence Interval 2
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-4.1 units on a scale	95% Confidence Interval -4.3
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	2.1 units on a scale	95% Confidence Interval 1.9
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	1.9 units on a scale	95% Confidence Interval 1.5
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	1.0 units on a scale	95% Confidence Interval 0.8
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-4.2 units on a scale	95% Confidence Interval -4.4
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	0.8 units on a scale	95% Confidence Interval 0.6
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	1.0 units on a scale	95% Confidence Interval 0.8
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	1.2 units on a scale	95% Confidence Interval 0.9
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	0.2 units on a scale	95% Confidence Interval 0
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	0.3 units on a scale	95% Confidence Interval 0
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-4.2 units on a scale	95% Confidence Interval -4.4
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	0.1 units on a scale	95% Confidence Interval -0.1
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	0.1 units on a scale	95% Confidence Interval -0.1

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.483295% CI: [-0.4, 0.2]Mixed Models Analysis

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.655395% CI: [-0.3, 0.2]Mixed Models Analysis

Comparison: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.2, 0.3]

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-1.5, -1.1]Mixed Models Analysis

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-2.2, -1.7]Mixed Models Analysis

Comparison: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.9, -0.4]

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-1.7, -1]Mixed Models Analysis

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-2.5, -1.8]Mixed Models Analysis

Comparison: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-1.1, -0.5]

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-1.4, -0.6]Mixed Models Analysis

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-2.2, -1.4]Mixed Models Analysis

Comparison: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-1.1, -0.5]

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.00295% CI: [-1.2, -0.3]Mixed Models Analysis

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-2.2, -1.2]Mixed Models Analysis

Comparison: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-1.3, -0.6]

Secondary

Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 12	-6.1 units on a scale
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 16	3.4 units on a scale
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 28	2.4 units on a scale
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 40	2.2 units on a scale
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 52	1.8 units on a scale
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 12	-5.0 units on a scale
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 16	2.3 units on a scale
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 28	1.3 units on a scale
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 40	1.3 units on a scale
PF-04965842 200 mg OL to Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 52	1.2 units on a scale
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 40	0.6 units on a scale
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 12	-6.1 units on a scale
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 12	-5.0 units on a scale
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 52	1.3 units on a scale
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 16	1.2 units on a scale
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 52	0.9 units on a scale
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 28	0.6 units on a scale
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 28	1.1 units on a scale
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 16	0.5 units on a scale
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 40	1.2 units on a scale
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 28	0.2 units on a scale
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 40	0.4 units on a scale
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 52	0.5 units on a scale
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 12	-5.1 units on a scale
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 40	0.2 units on a scale
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 16	0.0 units on a scale
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 12	-6.1 units on a scale
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Sleep Loss VAS: Change at Week 52	0.3 units on a scale
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 16	0.2 units on a scale
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Pruritus VAS: Change at Week 28	0.5 units on a scale

Comparison: Pruritus VAS: Week 12: The least squares mean (LSM) differences between treatment groups were derived from the statistical model. Mixed model repeated measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.920795% CI: [-0.3, 0.3]Mixed Models Analysis

Comparison: Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.999895% CI: [-0.3, 0.3]Mixed Models Analysis

Comparison: Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.3, 0.3]

Comparison: Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-2.5, -1.7]Mixed Models Analysis

Comparison: Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-3.6, -2.8]Mixed Models Analysis

Comparison: Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-1.4, -0.7]

Comparison: Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-2, -0.8]Mixed Models Analysis

Comparison: Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-2.5, -1.3]Mixed Models Analysis

Comparison: Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.9, -0.1]

Comparison: Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.003995% CI: [-1.7, -0.3]Mixed Models Analysis

Comparison: Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-2.5, -1.2]Mixed Models Analysis

Comparison: Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-1.3, -0.4]

Comparison: Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.148895% CI: [-1.2, 0.2]Mixed Models Analysis

Comparison: Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.000395% CI: [-2, -0.6]Mixed Models Analysis

Comparison: Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-1.2, -0.3]

Comparison: Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.929495% CI: [-0.2, 0.2]Mixed Models Analysis

Comparison: Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.408195% CI: [-0.3, 0.1]Mixed Models Analysis

Comparison: Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.3, 0.1]

Comparison: Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-2.1, -1.4]Mixed Models Analysis

Comparison: Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-2.7, -2]Mixed Models Analysis

Comparison: Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.9, -0.2]

Comparison: Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.003595% CI: [-1.2, -0.2]Mixed Models Analysis

Comparison: Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-1.6, -0.7]Mixed Models Analysis

Comparison: Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.8, -0.1]

Comparison: Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.013695% CI: [-1.2, -0.1]Mixed Models Analysis

Comparison: Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: <0.000195% CI: [-1.6, -0.6]Mixed Models Analysis

Comparison: Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-0.8, 0]

Comparison: Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.288795% CI: [-1, 0.3]Mixed Models Analysis

Comparison: Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.p-value: =0.002595% CI: [-1.6, -0.3]Mixed Models Analysis

Comparison: Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.95% CI: [-1, -0.2]

Secondary

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	4.5 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	4.1 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	30.5 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	3.7 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	4.5 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	16.5 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	30.3 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	15.2 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	15.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	18.6 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	28.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	30.1 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	28.3 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	30.2 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	28.9 percentage of participants

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.931395% CI: [-7.5, 8.1]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.604395% CI: [-9.8, 5.7]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [-10, 5.4]

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [6.6, 16.5]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [19.4, 31.2]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [6.6, 20.4]

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [7.7, 18]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [19.9, 32]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [6.3, 20.6]

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [6.5, 16.8]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [19.6, 31.8]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [7, 21.2]

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [9.2, 20]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [18.4, 30.5]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [2.7, 17.2]

Secondary

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema \[E\], induration/papulation \[I\], excoriation \[Ex\] and lichenification \[L\]) was scored separately for each of 4 body regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae and groin\] and lower limbs \[l\] \[including buttocks\]) 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); where A = area score. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	16.6 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	22.8 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	100.0 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	40.8 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	15.9 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	68.1 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	100.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	83.3 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	57.3 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	50.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	71.2 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	74.9 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	100.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	85.9 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	96.2 percentage of participants

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [0, 0]

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions. P-value was adjusted by disease severity at baseline and randomization strata.95% CI: [0, 0]

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [0, 0]

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [35.3, 50.1]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [49.1, 61.7]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [7.9, 17.9]

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [37.9, 53]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [56.4, 69.5]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions95% CI: [10.7, 24.7]

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [33.6, 48.5]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [51.3, 65.2]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [9.6, 25.5]

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [27.8, 42.8]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [48.3, 62.4]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [12.1, 28.5]

Secondary

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	15.1 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	18.0 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	99.2 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	27.0 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	14.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	60.4 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	100.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	76.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	54.2 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	46.5 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	65.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	71.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	99.6 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	80.5 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	92.5 percentage of participants

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.184895% CI: [-0.3, 1.7]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.597195% CI: [-0.9, 1.6]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [-1.1, 0.4]

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [42, 56.8]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [59.3, 71.7]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [10.3, 22.3]

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [35.2, 50.2]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [56, 69.2]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [12.3, 27.4]

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [32.1, 46.9]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [49.8, 63.7]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [9.3, 25.5]

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [25.7, 40.4]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [44.6, 58.8]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [10.8, 27.6]

Secondary

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	84.6 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	10.6 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	13.9 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	12.1 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	10.5 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	41.5 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	37.6 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	87.1 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	51.3 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	46.9 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	77.1 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	54.5 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	58.7 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	86.4 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	64.5 percentage of participants

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.399495% CI: [-3.3, 8.4]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.554295% CI: [-4.1, 7.8]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [-6.5, 5]

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [30.2, 44.9]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [56.8, 69.8]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [17.7, 33.4]

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [29.9, 44]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [47.3, 61]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [8.9, 25.5]

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [22.7, 37]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [39.6, 53.8]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [8.5, 25.3]

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [20.4, 34.3]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [36.7, 50.9]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [8.4, 25.2]

Secondary

Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period

Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated greater severity.

Time frame: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

Population: FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 12	56.2 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 2	56.6 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 4	63.2 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 8	67.2 percentage of participants

Secondary

Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period

IGA assessed severity of AD on a 5-point scale (0-4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions.

Time frame: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

Population: Full analysis set-rescue (FAS-RE) included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 2	30.7 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 4	54.6 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 8	60.2 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 12	64.1 percentage of participants

Secondary

Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period

IGA assessed severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep dark red lesions.

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 40	10.6 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 28	10.5 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 12	99.6 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 16	15.4 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 52	11.7 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 28	45.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 12	99.6 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 16	55.5 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 40	42.3 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 52	36.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 52	54.1 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 40	57.1 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 12	99.2 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 28	61.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period	Week 16	77.8 percentage of participants

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.949595% CI: [-1, 1.1]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.571795% CI: [-1.6, 0.9]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [-1.7, 0.9]

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [33.1, 47.8]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [56.1, 69.2]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [14.3, 29.9]

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [28.1, 42]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [44.6, 58.4]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [8.1, 24.8]

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [25.2, 39.2]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [39.9, 53.8]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [5.9, 22.6]

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [18.5, 32.5]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [35.3, 49.7]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [8.6, 25.5]

Secondary

Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Participant responded to the following question: Overall, how would you describe your Atopic Dermatitis right now? on a 5-point scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	7.5 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	6.3 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	61.7 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	5.9 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	7.6 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	30.9 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	64.5 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	29.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	26.1 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	25.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	39.7 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	42.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	59.7 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	46.9 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	48.3 percentage of participants

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.481595% CI: [-5.3, 11.3]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.674895% CI: [-10.3, 6.6]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [-13.4, 3.2]

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [17.8, 30.3]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [35.6, 49]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions95% CI: [10.2, 26.6]

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [18.2, 31]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [33.7, 47.3]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [7.6, 24.1]

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [12.6, 25.1]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [27.6, 41.5]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [7.5, 23.7]

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [12.4, 25]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [25.4, 39.2]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [5.6, 21.7]

Secondary

Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	14.4 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	15.8 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	97.4 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	25.6 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	14.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	56.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	98.5 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	72.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	51.2 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	44.6 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	65.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	69.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	97.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	75.7 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	89.1 percentage of participants

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.424495% CI: [-1.4, 3.4]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.809295% CI: [-3.1, 2.4]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [-4.1, 1]

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [39.2, 54.2]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [57.2, 70]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [10.4, 23.5]

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [33.9, 48.7]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [53.1, 66.7]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [10.8, 26.6]

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [29.6, 44.4]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [47.6, 61.7]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [9.4, 26]

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [22.6, 37.4]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [43.8, 58.1]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [12.8, 29.5]

Secondary

Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period

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

Time frame: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

Population: FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 2	55.0 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 4	76.1 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 8	79.6 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 12	79.8 percentage of participants

Secondary

Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	8.3 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	7.5 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	73.6 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	9.4 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	7.6 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	37.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	75.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	38.3 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	32.7 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	31.8 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	45.9 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	47.7 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	71.3 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	56.3 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	67.3 percentage of participants

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.723295% CI: [-6.1, 8.8]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.569495% CI: [-9.8, 5.4]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [-11.2, 3.8]

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [22.2, 35.8]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [51.2, 64.5]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [20.8, 37]

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [23.9, 37.2]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [42.1, 55.6]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [9.8, 26.6]

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [18.4, 31.5]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [32.7, 46.5]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [6.3, 22.8]

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [18.1, 31.2]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [31.6, 45.3]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [5.6, 22.3]

Secondary

Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period

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

Time frame: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

Population: FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 2	16.9 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 4	33.9 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 8	44.4 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Rescue Week 12	45.4 percentage of participants

Secondary

Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated worse disease status.

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Arm	Measure	Group	Value (NUMBER)
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	10.1 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	11.6 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	82.2 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	15.9 percentage of participants
PF-04965842 200 mg OL to Placebo DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	8.3 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	45.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	84.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	54.6 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	39.4 percentage of participants
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	27.6 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 52	49.0 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 40	55.7 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 12	81.9 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 28	66.9 percentage of participants
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Week 16	75.6 percentage of participants

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.608295% CI: [-5, 8.5]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: =0.96495% CI: [-6.7, 7]Cochran-Mantel-Haenszel

Comparison: Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [-9.1, 4.4]

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [31.2, 46.5]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [52.7, 66.7]Cochran-Mantel-Haenszel

Comparison: Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [12.7, 29]

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [26.6, 41.2]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [48.2, 62.3]Cochran-Mantel-Haenszel

Comparison: Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [13.2, 30.2]

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [22.7, 36.7]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [38.4, 52.7]Cochran-Mantel-Haenszel

Comparison: Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [7.4, 24.6]

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [13, 26.8]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.p-value: <0.000195% CI: [32.8, 48.1]Cochran-Mantel-Haenszel

Comparison: Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.95% CI: [11.8, 30]

Secondary

Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period

4 body regions evaluated: head and neck, upper limbs, trunk (including axillae, groin/genitals), lower limbs (including buttocks) excluding scalp, palms, soles. BSA calculated by handprint method. Number (No) of handprints (size of participant's hand with fingers in closed position) fitting in affected area of a body region was estimated. Maximum No of handprints were 10, 20, 30, 40 for head and neck, upper limbs, trunk, and lower limbs respectively. Surface area (SA) of body region equivalent to 1 handprint: 1 handprint=10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. %Change BSA for a body region was calculated as=total No of handprints in a body region\* %SA equivalent to 1 handprint. %BSA for an individual: arithmetic mean of %BSA of all 4 body regions, ranged from 0-100%, higher values=greater AD severity.

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Arm	Measure	Group	Value (MEDIAN)
PF-04965842 200 mg OL to Placebo DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	-91.2 percent change
PF-04965842 200 mg OL to Placebo DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	-85.2 percent change
PF-04965842 200 mg OL to Placebo DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-95.6 percent change
PF-04965842 200 mg OL to Placebo DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	-68.5 percent change
PF-04965842 200 mg OL to Placebo DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	-91.5 percent change
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	-93.8 percent change
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-96.7 percent change
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	-90.9 percent change
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	-95.8 percent change
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	-96.9 percent change
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	-96.9 percent change
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	-96.8 percent change
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-96.7 percent change
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	-96.4 percent change
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	-96.3 percent change

Secondary

Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period

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

Time frame: Baseline, Weeks 12, 16, 28, 40 and 52

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points.

Arm	Measure	Group	Value (MEDIAN)
PF-04965842 200 mg OL to Placebo DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	-74.4 percent change
PF-04965842 200 mg OL to Placebo DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	-63.4 percent change
PF-04965842 200 mg OL to Placebo DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-84.0 percent change
PF-04965842 200 mg OL to Placebo DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	-50.4 percent change
PF-04965842 200 mg OL to Placebo DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	-73.3 percent change
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	-77.8 percent change
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-84.4 percent change
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	-71.7 percent change
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	-77.1 percent change
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	-82.5 percent change
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 52	-83.2 percent change
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 40	-84.6 percent change
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 12	-84.4 percent change
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 28	-83.8 percent change
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period	Change at Week 16	-83.6 percent change

Secondary

Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period

4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) 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 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. Overall % BSA for an individual % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.

Time frame: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

Population: FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Change at Rescue Week 2	-62.8 percent change
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Change at Rescue Week 4	-76.4 percent change
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Change at Rescue Week 8	-82.1 percent change
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Change at Rescue Week 12	-83.3 percent change

Secondary

Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period

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

Time frame: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

Population: FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment.. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Pruritus VAS: Change at Rescue Week 2	-57.3 percent change	95% Confidence Interval -61.7
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Pruritus VAS: Change at Rescue Week 4	-67.5 percent change	95% Confidence Interval -71.3
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Pruritus VAS: Change at Rescue Week 8	-68.6 percent change	95% Confidence Interval -73.6
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Pruritus VAS: Change at Rescue Week 12	-67.3 percent change	95% Confidence Interval -72.8
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Sleep Loss VAS: Change at Rescue Week 2	-62.5 percent change	95% Confidence Interval -69.1
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Sleep Loss VAS: Change at Rescue Week 4	-72.4 percent change	95% Confidence Interval -78.6
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Sleep Loss VAS: Change at Rescue Week 8	-75.8 percent change	95% Confidence Interval -82
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Sleep Loss VAS: Change at Rescue Week 12	-74.5 percent change	95% Confidence Interval -81.4

Secondary

Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period

EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of 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). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD.

Time frame: Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12

Population: FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Change at Rescue Week 2	-71.1 percent change	95% Confidence Interval -73.7
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Change at Rescue Week 4	-82.0 percent change	95% Confidence Interval -84.2
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Change at Rescue Week 8	-86.4 percent change	95% Confidence Interval -88.2
PF-04965842 200 mg OL to Placebo DB	Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period	Change at Rescue Week 12	-87.3 percent change	95% Confidence Interval -89.4

Secondary

Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period

Time (in days) to loss of response based on achieving IGA \>=2 (for the first time) as measured from date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue). IGA assesses severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions.

Time frame: From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window +/- 7 Days)

Population: FAS-RA included as all participants who were randomized at Week 12 and received at least one dose of study medication within the double-blind phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment. Here, Overall 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Arm	Measure	Value (MEDIAN)	Dispersion
PF-04965842 200 mg OL to Placebo DB	Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period	27.0 days	95% Confidence Interval 26
PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB	Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period	78.0 days	95% Confidence Interval 32
PF-04965842 200 mg OL to PF-04965842 200 mg DB	Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period	201.0 days	95% Confidence Interval 177

Comparison: A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.p-value: <0.000195% CI: [0.286, 0.424]Log Rank

Comparison: A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.p-value: <0.000195% CI: [0.176, 0.27]Log Rank

Comparison: A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.p-value: <0.000195% CI: [0.503, 0.78]Log Rank

Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With Loss of Response: Double-blind (DB) Period

Time to Loss of Response: Double-blind Period

Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period

Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period

Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period

Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period

Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period

Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period

Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period

Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period

Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period

Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period