Dermatitis, Dermatitis, Atopic, Eczema, Genetic Diseases, Inborn, Hypersensitivity, Hypersensitivity, Immediate, Immune System Diseases, Skin Diseases, Skin Diseases, Eczematous, Skin Diseases, Genetic
Conditions
Keywords
atopic dermatitis, atopic eczema, eczema, JAK, janus kinase
Brief summary
B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily will be evaluated relative to placebo over 12 weeks. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.
Interventions
PF-04965842 100 mg, administered as two tablets to be taken orally once daily as follows: 1. In the arm PF-04965842 100 mg + Injectable Placebo followed by PF-04965842 100 mg, PF-04965842 100 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20; 2. In the arm Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842 subjects take PF-04965842 100 mg from Week 16 to Week 20.
PF-04965842 200 mg, administered as two tablets to be taken orally once daily as follows: 1. In the arm PF-04965842 200 mg + Injectable Placebo followed by PF-04965842 100 mg, PF-04965842 200 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20; 2. In the arm Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842 subjects take PF-04965842 200 mg from Week 16 to Week 20.
DRUGDupilumab
Two subcutaneous injections of Dupilumab 300 mg as a loading dose administered on Day 1 (for a total of 600 mg) followed by one injection once every two weeks (q2w) until Week 16.
DRUGOral Placebo
Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows: 1. In the arm Dupilumab Injection + Oral Placebo followed by Oral Placebo, the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20; 2. In the arms Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842 and Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842, subjects, take Oral Placebo from Day 1 until Week 16.
Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects aged 18 years or older at the time of informed consent * Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (\>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4) * Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease. * Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study * Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply: 1. Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization; 2. Female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product. * Female subjects of non-childbearing potential must meet at least 1 of the following criteria: * Have undergone a documented hysterectomy and/or bilateral oophorectomy; * Have medically confirmed ovarian failure; or * Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential. -If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study
Exclusion criteria
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study * Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator * Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study * Other active nonAD inflammatory skin diseases or conditions affecting skin * Prior treatment with JAK inhibitors * Previous treatment with dupilumab * Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Week 12 | Baseline (the last measurement prior to first dosing on Day 1), Week 12 | IGA assessed severity of atopic dermatitis (AD) on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded scalp, palms and sole. |
| Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12 | Baseline, Week 12 | EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Baseline, Week 2, 4, 8 and 16 | EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. |
| Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Baseline, Week 2, 4, 8, 12 and 16 | EASI evaluates severity of participants' 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); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. |
| Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Baseline, Week 2, 4, 8,12 and 16 | EASI evaluates severity of participants' 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); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. |
| Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Baseline, Week 2, 4, 8, 12 and 16 | EASI evaluates severity of participants' 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); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. |
| Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS | Baseline up to Week 16 | Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity. |
| Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Baseline, Week 2, 4, 8, 12 and 16 | 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD. |
| Percentage BSA at Week 18 and 20 | Week 18 and 20 | 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD. |
| Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Baseline, Week 2, 4, 8, 12 and 16 | Participant responded to the following question: Overall, how would you describe your Atopic Dermatitis right now? on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Baseline, Week 2, 12 and 16 | DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. |
| DLQI at Week 20 | Week 20 | DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. |
| Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 | Baseline, Week 12 and 16 | EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded no problems for each 5 dimensions, then health state was coded as 11111 with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state. |
| Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 | Baseline, Week 12 and 16 | EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. |
| EQ-5D-5L- Index Value at Week 20 | Week 20 | EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded no problems for each 5 dimensions, then health state was coded as 11111 with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state. |
| Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16 | Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity. |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 | Baseline, Weeks 12 and 16 | 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-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety. |
| Change From Baseline in HADS - Depression Scale at Week 12 and 16 | Baseline, Week 12 and 16 | 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-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms. |
| HADS - Anxiety Scale at Week 20 | Week 20 | 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-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety. |
| HADS - Depression Scale at Week 20 | Week 20 | 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-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms. |
| Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 | Baseline, Week 12 and 16 | POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: no days (0), 1-2 days (1), 3-4 days (2), 5-6 days (3) and every day (4). The score ranges from 0 to 28, where higher score indicated greater severity. |
| POEM at Week 20 | Week 20 | POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: no days (0), 1-2 days (1), 3-4 days (2), 5-6 days (3) and every day (4). The score ranges from 0 to 28, where higher score indicated greater severity. |
| Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Baseline, Week 1 to Week 16 | PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. |
| PSAAD Total Score at Week 18 and 20 | Week 18 and 20 | PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. |
| Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Baseline, Week 2, 4, 8 12 and 16 | SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where 0 = no itch/no sleeplessness and 10 = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. |
| Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Baseline, Week 2, 4, 8 12 and 16 | SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where 0 = no itch/no sleeplessness and 10 = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. |
| Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Baseline, Week 2, 4, 8 12 and 16 | SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where 0 = no itch/no sleeplessness and 10 = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. |
| SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Week 18 and 20 | SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where 0 = no itch/no sleeplessness and 10 = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. |
| Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16 | Baseline up to Week 16 | Number of days when a corticosteroid as a concomitant medication was not used up to Week 16 is reported as Least square mean in this outcome measure. |
| EQ-5D-5L- VAS Score at Week 20 | Week 20 | EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. |
| Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Baseline, Week 2, 4, 8 and 16 | IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp. |
Countries
Australia, Bulgaria, Canada, Chile, Czechia, Germany, Hungary, Italy, Japan, Latvia, Mexico, Poland, Slovakia, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Pre-assignment details
The study had treatment period of 20 weeks. The first part of this treatment period consists of a 16-week randomized, double-blind, placebo-controlled, double-dummy treatment period where participants received PF-04965842, dupilumab and placebo. The randomization and double-blind was maintained during the final 4 weeks of the treatment period, but participants only received PF-04965842 and placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo up to Week 16 Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16. | 131 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. | 238 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. | 226 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, followed by administration of oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. | 242 |
| Total | 837 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Treatment Period: Final 4 Weeks | Adverse Event | 0 | 0 | 0 | 2 | 1 | 1 |
| Treatment Period: Final 4 Weeks | Lack of Efficacy | 0 | 0 | 1 | 0 | 0 | 0 |
| Treatment Period: Final 4 Weeks | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 1 |
| Treatment Period: Final 4 Weeks | Other | 0 | 1 | 0 | 2 | 1 | 0 |
| Treatment Period: Final 4 Weeks | Pregnancy | 0 | 0 | 0 | 0 | 0 | 1 |
| Treatment Period: Final 4 Weeks | Protocol Deviation | 0 | 0 | 1 | 0 | 0 | 0 |
| Treatment Period: Final 4 Weeks | Withdrawal by Subject | 0 | 1 | 0 | 2 | 2 | 2 |
| Treatment Period: First Part 16 Weeks | Adverse Event | 5 | 0 | 0 | 5 | 8 | 6 |
| Treatment Period: First Part 16 Weeks | Lack of Efficacy | 0 | 0 | 0 | 1 | 0 | 1 |
| Treatment Period: First Part 16 Weeks | Lost to Follow-up | 1 | 0 | 0 | 2 | 1 | 2 |
| Treatment Period: First Part 16 Weeks | Medication Error Without Associated Adverse Event | 0 | 0 | 0 | 1 | 1 | 0 |
| Treatment Period: First Part 16 Weeks | Other | 1 | 0 | 0 | 1 | 2 | 2 |
| Treatment Period: First Part 16 Weeks | Pregnancy | 0 | 0 | 0 | 0 | 1 | 1 |
| Treatment Period: First Part 16 Weeks | Protocol deviation | 2 | 0 | 0 | 2 | 2 | 1 |
| Treatment Period: First Part 16 Weeks | Randomized But Not Treated | 0 | 0 | 0 | 0 | 0 | 1 |
| Treatment Period: First Part 16 Weeks | Withdrawal by Subject | 5 | 0 | 0 | 9 | 3 | 6 |
Baseline characteristics
| Characteristic | Placebo up to Week 16 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 14 Participants | 15 Participants | 15 Participants | 54 Participants |
| Age, Categorical Between 18 and 65 years | 121 Participants | 224 Participants | 211 Participants | 227 Participants | 783 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 35 Participants | 36 Participants | 37 Participants | 124 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 113 Participants | 200 Participants | 187 Participants | 201 Participants | 701 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 31 Participants | 48 Participants | 53 Participants | 46 Participants | 178 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 6 Participants | 9 Participants | 14 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 87 Participants | 182 Participants | 161 Participants | 176 Participants | 606 Participants |
| Sex: Female, Male Female | 54 Participants | 118 Participants | 122 Participants | 134 Participants | 428 Participants |
| Sex: Female, Male Male | 77 Participants | 120 Participants | 104 Participants | 108 Participants | 409 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 131 | 0 / 238 | 0 / 226 | 0 / 242 | 0 / 60 | 0 / 57 | 0 / 217 | 0 / 208 | 0 / 223 |
| other Total, other adverse events | 68 / 131 | 121 / 238 | 140 / 226 | 120 / 242 | 13 / 60 | 16 / 57 | 50 / 217 | 45 / 208 | 31 / 223 |
| serious Total, serious adverse events | 5 / 131 | 6 / 238 | 2 / 226 | 2 / 242 | 0 / 60 | 0 / 57 | 1 / 217 | 0 / 208 | 1 / 223 |
Outcome results
Primary
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12
EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time frame: Baseline, Week 12
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo up to Week 16 | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12 | 27.1 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12 | 58.7 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12 | 70.3 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12 | 58.1 Percentage of participants |
Comparison: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.p-value: <0.000195% CI: [22.2, 41.6]Cochran-Mantel-Haenszel
Comparison: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.p-value: <0.000195% CI: [33.7, 52.7]Cochran-Mantel-Haenszel
Primary
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 Week 12
IGA assessed severity of atopic dermatitis (AD) on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded scalp, palms and sole.
Time frame: Baseline (the last measurement prior to first dosing on Day 1), Week 12
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo up to Week 16 | 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 Week 12 | 14.0 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | 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 Week 12 | 36.6 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | 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 Week 12 | 48.4 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | 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 Week 12 | 36.5 Percentage of participants |
Comparison: Difference in percentage (PF-04965842 versus placebo) and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.p-value: <0.000195% CI: [14.7, 31.4]Cochran-Mantel-Haenszel
Comparison: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.p-value: <0.000195% CI: [26.1, 43.5]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16
DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Time frame: Baseline, Week 2, 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo up to Week 16 | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Change at Week 2 | -4.5 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Change at Week 16 | -6.2 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Change at Week 12 | -6.2 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Change at Week 2 | -6.7 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Change at Week 16 | -9.0 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Change at Week 12 | -8.7 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Change at Week 12 | -11.0 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Change at Week 2 | -8.5 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Change at Week 16 | -11.7 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Change at Week 2 | -6.7 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Change at Week 16 | -10.8 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | Change at Week 12 | -9.9 units on a scale |
Secondary
Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16
EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Time frame: Baseline, Week 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo up to Week 16 | Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 | Change at Week 12 | 7.975 units on a scale |
| Placebo up to Week 16 | Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 | Change at Week 16 | 7.840 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 | Change at Week 16 | 11.223 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 | Change at Week 12 | 11.337 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 | Change at Week 12 | 17.373 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 | Change at Week 16 | 16.711 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 | Change at Week 12 | 14.939 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 | Change at Week 16 | 14.405 units on a scale |
Secondary
Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16
EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded no problems for each 5 dimensions, then health state was coded as 11111 with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.
Time frame: Baseline, Week 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo up to Week 16 | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 | Change at Week 12 | 0.051 units on a scale |
| Placebo up to Week 16 | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 | Change at Week 16 | 0.067 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 | Change at Week 12 | 0.101 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 | Change at Week 16 | 0.093 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 | Change at Week 12 | 0.127 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 | Change at Week 16 | 0.133 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 | Change at Week 16 | 0.113 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 | Change at Week 12 | 0.104 units on a scale |
Secondary
Change From Baseline in HADS - Depression Scale at Week 12 and 16
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-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
Time frame: Baseline, Week 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo up to Week 16 | Change From Baseline in HADS - Depression Scale at Week 12 and 16 | Change at Week 16 | -0.3 units on a scale |
| Placebo up to Week 16 | Change From Baseline in HADS - Depression Scale at Week 12 and 16 | Change at Week 12 | -0.3 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in HADS - Depression Scale at Week 12 and 16 | Change at Week 12 | -1.3 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in HADS - Depression Scale at Week 12 and 16 | Change at Week 16 | -1.0 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in HADS - Depression Scale at Week 12 and 16 | Change at Week 16 | -1.6 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in HADS - Depression Scale at Week 12 and 16 | Change at Week 12 | -1.6 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in HADS - Depression Scale at Week 12 and 16 | Change at Week 16 | -1.2 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in HADS - Depression Scale at Week 12 and 16 | Change at Week 12 | -1.3 units on a scale |
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16
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-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
Time frame: Baseline, Weeks 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo up to Week 16 | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 | Change at Week 16 | -0.4 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 | Change at Week 12 | -0.4 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 | Change at Week 12 | -1.2 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 | Change at Week 16 | -1.2 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 | Change at Week 16 | -2.0 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 | Change at Week 12 | -1.6 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 | Change at Week 16 | -1.5 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 | Change at Week 12 | -1.4 units on a scale |
Secondary
Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16
Participant responded to the following question: Overall, how would you describe your Atopic Dermatitis right now? on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.
Time frame: Baseline, Week 2, 4, 8, 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 4 | -0.5 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 12 | -0.7 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 2 | -0.5 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 8 | -0.6 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 16 | -0.7 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 4 | -1.0 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 16 | -1.2 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 8 | -1.1 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 12 | -1.2 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 2 | -0.8 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 2 | -1.0 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 4 | -1.4 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 12 | -1.6 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 16 | -1.6 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 8 | -1.5 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 16 | -1.4 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 2 | -0.7 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 8 | -1.3 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 12 | -1.3 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Change at Week 4 | -1.1 units on a scale |
Secondary
Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16
POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: no days (0), 1-2 days (1), 3-4 days (2), 5-6 days (3) and every day (4). The score ranges from 0 to 28, where higher score indicated greater severity.
Time frame: Baseline, Week 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo up to Week 16 | Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 | Change at Week 12 | -5.1 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 | Change at Week 16 | -5.0 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 | Change at Week 16 | -9.2 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 | Change at Week 12 | -9.6 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 | Change at Week 12 | -12.6 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 | Change at Week 16 | -12.5 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 | Change at Week 12 | -10.8 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 | Change at Week 16 | -10.8 units on a scale |
Secondary
Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Time frame: Baseline, Week 2, 4, 8, 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 2 | -7.6 Percentage BSA |
| Placebo up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 4 | -14.3 Percentage BSA |
| Placebo up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 8 | -16.2 Percentage BSA |
| Placebo up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 16 | -19.6 Percentage BSA |
| Placebo up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 12 | -17.1 Percentage BSA |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 2 | -19.5 Percentage BSA |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 12 | -31.6 Percentage BSA |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 4 | -26.8 Percentage BSA |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 16 | -32.9 Percentage BSA |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 8 | -30.3 Percentage BSA |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 16 | -39.0 Percentage BSA |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 2 | -21.4 Percentage BSA |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 4 | -30.7 Percentage BSA |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 12 | -37.4 Percentage BSA |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 8 | -36.4 Percentage BSA |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 4 | -24.0 Percentage BSA |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 8 | -29.8 Percentage BSA |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 12 | -32.5 Percentage BSA |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 16 | -34.4 Percentage BSA |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | Change at Week 2 | -14.0 Percentage BSA |
Secondary
Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16
PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Time frame: Baseline, Week 1 to Week 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 7 | -1.6 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 15 | -1.7 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 1 | -0.5 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 13 | -1.7 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 8 | -1.5 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 14 | -1.6 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 12 | -1.6 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 9 | -1.7 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 5 | -1.5 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 16 | -1.7 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 11 | -1.6 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 2 | -0.9 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 6 | -1.5 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 3 | -1.1 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 10 | -1.7 units on a scale |
| Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 4 | -1.4 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 10 | -2.7 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 2 | -1.8 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 3 | -2.2 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 4 | -2.4 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 5 | -2.6 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 6 | -2.6 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 7 | -2.7 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 8 | -2.7 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 9 | -2.7 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 11 | -2.7 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 12 | -2.7 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 16 | -2.8 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 1 | -1.1 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 13 | -2.8 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 14 | -2.8 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 15 | -2.9 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 4 | -3.0 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 16 | -3.6 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 7 | -3.4 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 15 | -3.6 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 1 | -1.3 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 2 | -2.3 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 3 | -2.8 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 6 | -3.3 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 10 | -3.5 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 5 | -3.2 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 13 | -3.7 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 14 | -3.6 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 9 | -3.5 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 11 | -3.5 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 8 | -3.4 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 12 | -3.6 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 8 | -3.0 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 12 | -3.2 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 7 | -2.9 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 16 | -3.4 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 10 | -3.1 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 14 | -3.4 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 15 | -3.4 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 11 | -3.2 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 1 | -0.9 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 13 | -3.3 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 4 | -2.4 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 3 | -2.1 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 6 | -2.8 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 9 | -3.1 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 2 | -1.6 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | Change at Week 5 | -2.7 units on a scale |
Secondary
Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where 0 = no itch/no sleeplessness and 10 = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Time frame: Baseline, Week 2, 4, 8 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 12 | -2.4 units on a scale |
| Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 4 | -2.2 units on a scale |
| Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 2 | -1.5 units on a scale |
| Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 2 | -1.6 units on a scale |
| Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 4 | -2.3 units on a scale |
| Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 16 | -2.7 units on a scale |
| Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 8 | -2.3 units on a scale |
| Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 8 | -2.3 units on a scale |
| Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 12 | -2.4 units on a scale |
| Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 16 | -2.6 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 16 | -3.8 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 4 | -3.7 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 16 | -3.7 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 12 | -3.9 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 4 | -3.4 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 8 | -3.9 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 12 | -3.7 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 2 | -2.9 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 2 | -2.6 units on a scale |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 8 | -3.6 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 2 | -3.3 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 12 | -4.6 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 16 | -4.8 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 16 | -4.8 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 2 | -3.7 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 4 | -4.2 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 8 | -4.4 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 4 | -4.6 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 8 | -4.9 units on a scale |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 12 | -5.0 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 16 | -4.3 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 2 | -2.4 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 4 | -3.7 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 12 | -4.4 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 16 | -4.5 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 2 | -2.3 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 8 | -3.9 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Itch: Change at Week 8 | -4.2 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 4 | -3.4 units on a scale |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | Sleep loss: Change at Week 12 | -4.2 units on a scale |
Secondary
DLQI at Week 20
DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Time frame: Week 20
Population: Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo up to Week 16 | DLQI at Week 20 | 5.3 units on a scale | Standard Deviation 5.3 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | DLQI at Week 20 | 5.8 units on a scale | Standard Deviation 5.7 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | DLQI at Week 20 | 6.3 units on a scale | Standard Deviation 5.8 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | DLQI at Week 20 | 4.3 units on a scale | Standard Deviation 4.7 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | DLQI at Week 20 | 5.6 units on a scale | Standard Deviation 4.8 |
Secondary
EQ-5D-5L- Index Value at Week 20
EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded no problems for each 5 dimensions, then health state was coded as 11111 with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.
Time frame: Week 20
Population: Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo up to Week 16 | EQ-5D-5L- Index Value at Week 20 | 0.905 units on a scale | Standard Deviation 0.097 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | EQ-5D-5L- Index Value at Week 20 | 0.894 units on a scale | Standard Deviation 0.122 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | EQ-5D-5L- Index Value at Week 20 | 0.883 units on a scale | Standard Deviation 0.124 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | EQ-5D-5L- Index Value at Week 20 | 0.917 units on a scale | Standard Deviation 0.109 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | EQ-5D-5L- Index Value at Week 20 | 0.890 units on a scale | Standard Deviation 0.109 |
Secondary
EQ-5D-5L- VAS Score at Week 20
EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Time frame: Week 20
Population: Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo up to Week 16 | EQ-5D-5L- VAS Score at Week 20 | 78.2 units on a scale | Standard Deviation 16.3 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | EQ-5D-5L- VAS Score at Week 20 | 78.5 units on a scale | Standard Deviation 20.2 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | EQ-5D-5L- VAS Score at Week 20 | 76.7 units on a scale | Standard Deviation 19.5 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | EQ-5D-5L- VAS Score at Week 20 | 82.1 units on a scale | Standard Deviation 17.1 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | EQ-5D-5L- VAS Score at Week 20 | 79.6 units on a scale | Standard Deviation 18 |
Secondary
HADS - Anxiety Scale at Week 20
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-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
Time frame: Week 20
Population: Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo up to Week 16 | HADS - Anxiety Scale at Week 20 | 3.4 units on a scale | Standard Deviation 3.2 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | HADS - Anxiety Scale at Week 20 | 4.5 units on a scale | Standard Deviation 4.5 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | HADS - Anxiety Scale at Week 20 | 4.0 units on a scale | Standard Deviation 3.8 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | HADS - Anxiety Scale at Week 20 | 3.1 units on a scale | Standard Deviation 3.1 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | HADS - Anxiety Scale at Week 20 | 3.7 units on a scale | Standard Deviation 3.5 |
Secondary
HADS - Depression Scale at Week 20
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-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
Time frame: Week 20
Population: Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo up to Week 16 | HADS - Depression Scale at Week 20 | 2.6 units on a scale | Standard Deviation 3.4 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | HADS - Depression Scale at Week 20 | 3.6 units on a scale | Standard Deviation 3.7 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | HADS - Depression Scale at Week 20 | 2.8 units on a scale | Standard Deviation 3.2 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | HADS - Depression Scale at Week 20 | 2.2 units on a scale | Standard Deviation 3.1 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | HADS - Depression Scale at Week 20 | 2.7 units on a scale | Standard Deviation 3.3 |
Secondary
Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16
Number of days when a corticosteroid as a concomitant medication was not used up to Week 16 is reported as Least square mean in this outcome measure.
Time frame: Baseline up to Week 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo up to Week 16 | Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16 | 21.8 Days |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16 | 30.2 Days |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16 | 33.6 Days |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16 | 28.1 Days |
Secondary
Percentage BSA at Week 18 and 20
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Time frame: Week 18 and 20
Population: Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo up to Week 16 | Percentage BSA at Week 18 and 20 | Week 20 | 18.0 Percentage BSA | Standard Deviation 21.2 |
| Placebo up to Week 16 | Percentage BSA at Week 18 and 20 | Week 18 | 22.0 Percentage BSA | Standard Deviation 23.67 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage BSA at Week 18 and 20 | Week 20 | 16.0 Percentage BSA | Standard Deviation 19.7 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage BSA at Week 18 and 20 | Week 18 | 20.8 Percentage BSA | Standard Deviation 22.7 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage BSA at Week 18 and 20 | Week 20 | 14.2 Percentage BSA | Standard Deviation 19 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage BSA at Week 18 and 20 | Week 18 | 14.8 Percentage BSA | Standard Deviation 19.3 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage BSA at Week 18 and 20 | Week 18 | 9.8 Percentage BSA | Standard Deviation 13.6 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage BSA at Week 18 and 20 | Week 20 | 10.3 Percentage BSA | Standard Deviation 14.2 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Percentage BSA at Week 18 and 20 | Week 20 | 13.2 Percentage BSA | Standard Deviation 16.3 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Percentage BSA at Week 18 and 20 | Week 18 | 13.2 Percentage BSA | Standard Deviation 16.4 |
Secondary
Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16
EASI evaluates severity of participants' 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); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time frame: Baseline, Week 2, 4, 8, 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 1.6 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 0 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 0 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 0 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 4.0 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 1.3 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 6.0 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 2.6 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 8.1 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 12.7 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 13.6 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 7.2 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 11.6 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 4.5 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 12.3 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 2.5 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 6.6 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 0.4 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 5.2 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 2.1 Percentage of participants |
Secondary
Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16
EASI evaluates severity of participants' 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); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time frame: Baseline, Week 2, 4, 8, 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 57.3 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 21.9 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 52.7 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 39.8 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 48.8 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 81.2 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 53.1 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 78.9 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 73.4 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 75.3 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 88.4 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 60.5 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 78.5 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 87.3 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 86.3 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 66.8 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 84.1 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 77.4 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 35.7 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 80.9 Percentage of participants |
Secondary
Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16
EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time frame: Baseline, Week 2, 4, 8 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 16 | 30.6 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 2 | 10.9 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 4 | 15.6 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 8 | 18.6 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 8 | 55.6 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 4 | 44.6 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 2 | 25.4 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 16 | 60.3 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 4 | 57.4 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 8 | 67.9 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 2 | 30.0 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 16 | 71.0 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 2 | 14.0 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 16 | 65.5 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 8 | 52.7 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | Week 4 | 38.2 Percentage of participants |
Comparison: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.p-value: <0.000195% CI: [14, 34.1]Cochran-Mantel-Haenszel
Comparison: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.p-value: <0.000195% CI: [20.3, 39.8]Cochran-Mantel-Haenszel
Comparison: Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.95% CI: [-9.6, 4.2]
Comparison: Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.95% CI: [-3.3, 9.6]
Secondary
Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16
EASI evaluates severity of participants' 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); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time frame: Baseline, Week 2, 4, 8,12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 7.8 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 11.3 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 10.1 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 6.3 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 2.3 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 20.2 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 30.6 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 8.3 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 36.6 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 38.0 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 47.3 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 32.3 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 11.2 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 48.9 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 46.1 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 38.8 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 2.6 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 24.3 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 34.9 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 12.2 Percentage of participants |
Secondary
Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16
IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
Time frame: Baseline, Week 2, 4, 8 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 2 | 6.3 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 4 | 6.2 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 8 | 10.1 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 16 | 12.9 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 4 | 25.2 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 8 | 35.8 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 16 | 34.8 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 2 | 15.2 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 8 | 50.7 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 4 | 31.4 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 16 | 47.5 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 2 | 18.4 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 16 | 38.8 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 4 | 18.9 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 2 | 4.7 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | Week 8 | 28.5 Percentage of participants |
Comparison: Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.p-value: <0.000195% CI: [13.7, 30.5]Cochran-Mantel-Haenszel
Comparison: Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.p-value: <0.000195% CI: [26.3, 43.7]Cochran-Mantel-Haenszel
Comparison: Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.95% CI: [-12.2, 5.2]
Comparison: Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.95% CI: [0.4, 18.5]
Secondary
Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16
Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 2 | 5.1 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 12 | 12.0 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 2 | 13.8 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 13 | 13.2 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 5 | 7.6 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 14 | 15.7 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 15 | 11.1 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 12 | 28.9 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 6 | 10.9 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 3 | 7.9 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 7 | 11.1 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 8 | 14.4 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 16 | 28.7 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 8 | 27.0 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 9 | 13.0 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 4 | 6.0 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 10 | 13.2 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 4 | 20.2 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 11 | 12.7 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 10 | 25.6 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 2 | 31.8 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 9 | 24.0 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 12 | 25.5 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 12 | 47.5 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 7 | 20.1 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 2 | 5.9 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 13 | 30.6 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 8 | 47.5 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 15 | 30.4 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 4 | 11.6 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 14 | 31.4 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 5 | 14.2 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 8 | 21.4 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 16 | 47.0 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 4 | 44.6 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 11 | 25.4 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 6 | 15.0 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 3 | 8.4 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 8 | 64.0 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 2 | 7.4 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 3 | 14.8 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 4 | 18.6 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 5 | 26.5 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 6 | 25.1 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 7 | 28.8 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 8 | 33.3 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 9 | 34.1 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 10 | 34.3 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 11 | 39.5 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 12 | 44.1 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 13 | 43.8 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 14 | 45.7 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 15 | 49.0 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 2 | 49.1 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 4 | 59.3 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 12 | 63.1 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 16 | 62.8 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 11 | 20.5 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 3 | 3.3 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 2 | 26.4 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 10 | 17.1 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 9 | 14.8 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 2 | 2.4 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 4 | 45.3 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 8 | 16.5 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 7 | 13.4 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 6 | 14.0 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 8 | 50.7 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 5 | 9.5 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 4 | 5.6 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 16 | 57.1 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 14 | 24.5 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 13 | 23.6 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Week 12 | 54.5 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 15 | 26.5 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Day 12 | 21.9 Percentage of participants |
Comparison: Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.p-value: 0.000295% CI: [9.5, 26.3]Cochran-Mantel-Haenszel
Comparison: Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.p-value: <0.000195% CI: [26, 43.7]Cochran-Mantel-Haenszel
Comparison: Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.p-value: 0.208495% CI: [-2.9, 13.4]Cochran-Mantel-Haenszel
Comparison: Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.p-value: <0.000195% CI: [13.5, 30.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where 0 = no itch/no sleeplessness and 10 = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Time frame: Baseline, Week 2, 4, 8 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 2 | 1.6 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 4 | 3.1 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 12 | 6.3 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 8 | 3.1 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 16 | 10.6 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 16 | 26.8 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 8 | 19.2 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 4 | 12.4 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 2 | 6.4 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 12 | 25.6 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 8 | 41.3 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 4 | 25.4 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 16 | 40.3 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 12 | 39.3 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 2 | 8.5 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 2 | 0.8 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 4 | 7.1 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 12 | 26.1 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 8 | 16.3 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | Week 16 | 29.4 Percentage of participants |
Secondary
Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where 0 = no itch/no sleeplessness and 10 = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Time frame: Baseline, Week 2, 4, 8 12 and 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 33.3 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 20.2 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 10.2 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 18.6 Percentage of participants |
| Placebo up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 27.3 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 23.6 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 45.7 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 53.4 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 56.1 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 56.8 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 68.8 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 38.4 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 72.3 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 71.6 Percentage of participants |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 61.6 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 12 | 64.3 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 2 | 15.6 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 8 | 56.9 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 4 | 45.8 Percentage of participants |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | Week 16 | 67.5 Percentage of participants |
Secondary
POEM at Week 20
POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: no days (0), 1-2 days (1), 3-4 days (2), 5-6 days (3) and every day (4). The score ranges from 0 to 28, where higher score indicated greater severity.
Time frame: Week 20
Population: Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo up to Week 16 | POEM at Week 20 | 10.7 units on a scale | Standard Deviation 6.8 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | POEM at Week 20 | 9.6 units on a scale | Standard Deviation 7.8 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | POEM at Week 20 | 11.6 units on a scale | Standard Deviation 7.7 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | POEM at Week 20 | 8.6 units on a scale | Standard Deviation 7 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | POEM at Week 20 | 11.0 units on a scale | Standard Deviation 6.9 |
Secondary
PSAAD Total Score at Week 18 and 20
PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin \[lighter or darker\], bleeding from skin, seeping or oozing fluid from skin \[other than blood\], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Time frame: Week 18 and 20
Population: Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo up to Week 16 | PSAAD Total Score at Week 18 and 20 | Week 18 | 2.6 units on a scale | Standard Deviation 1.9 |
| Placebo up to Week 16 | PSAAD Total Score at Week 18 and 20 | Week 20 | 2.5 units on a scale | Standard Deviation 2 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | PSAAD Total Score at Week 18 and 20 | Week 18 | 3.0 units on a scale | Standard Deviation 2.4 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | PSAAD Total Score at Week 18 and 20 | Week 20 | 2.6 units on a scale | Standard Deviation 2.3 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | PSAAD Total Score at Week 18 and 20 | Week 18 | 2.2 units on a scale | Standard Deviation 1.9 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | PSAAD Total Score at Week 18 and 20 | Week 20 | 2.2 units on a scale | Standard Deviation 1.9 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | PSAAD Total Score at Week 18 and 20 | Week 20 | 1.8 units on a scale | Standard Deviation 1.8 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | PSAAD Total Score at Week 18 and 20 | Week 18 | 1.7 units on a scale | Standard Deviation 1.7 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | PSAAD Total Score at Week 18 and 20 | Week 18 | 1.8 units on a scale | Standard Deviation 1.5 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | PSAAD Total Score at Week 18 and 20 | Week 20 | 2.0 units on a scale | Standard Deviation 1.6 |
Secondary
SCORAD VAS of Itch and Sleep Loss at Week 18 and 20
SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where 0 = no itch/no sleeplessness and 10 = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Time frame: Week 18 and 20
Population: Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Itch: Week 18 | 3.2 units on a scale | Standard Deviation 2.6 |
| Placebo up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Sleep loss: Week 20 | 2.1 units on a scale | Standard Deviation 2.2 |
| Placebo up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Sleep loss: Week 18 | 2.2 units on a scale | Standard Deviation 2.3 |
| Placebo up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Itch: Week 20 | 2.9 units on a scale | Standard Deviation 2.4 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Itch: Week 18 | 2.7 units on a scale | Standard Deviation 2.2 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Sleep loss: Week 18 | 2.3 units on a scale | Standard Deviation 2.3 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Sleep loss: Week 20 | 2.0 units on a scale | Standard Deviation 2.3 |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Itch: Week 20 | 2.6 units on a scale | Standard Deviation 2.4 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Sleep loss: Week 20 | 2.4 units on a scale | Standard Deviation 2.6 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Itch: Week 18 | 3.0 units on a scale | Standard Deviation 2.5 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Itch: Week 20 | 3.2 units on a scale | Standard Deviation 2.6 |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Sleep loss: Week 18 | 2.1 units on a scale | Standard Deviation 2.3 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Itch: Week 18 | 2.3 units on a scale | Standard Deviation 2.2 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Sleep loss: Week 20 | 1.5 units on a scale | Standard Deviation 2.1 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Sleep loss: Week 18 | 1.6 units on a scale | Standard Deviation 2.1 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Itch: Week 20 | 2.3 units on a scale | Standard Deviation 2.3 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Sleep loss: Week 20 | 1.7 units on a scale | Standard Deviation 2.1 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Itch: Week 20 | 2.8 units on a scale | Standard Deviation 2.2 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Sleep loss: Week 18 | 1.8 units on a scale | Standard Deviation 2 |
| Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | Itch: Week 18 | 2.7 units on a scale | Standard Deviation 2.2 |
Secondary
Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS
Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
Time frame: Baseline up to Week 16
Population: Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Participants with a baseline numeric rating scale score for severity of pruritus \>=4 were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo up to Week 16 | Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS | NA Days |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS | 29.0 Days |
| PF-04965842 200 mg + Placebo Injection up to Week 16 | Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS | 13.0 Days |
| Dupilumab 300 mg + Oral Placebo up to Week 16 | Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS | 31.0 Days |