A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis

Dermatitis Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706040
• Other study ID #: M16-813
• Secondary ID: 2021-002203-34
• Status: Completed
• Phase: Phase 2
• Start date: December 27, 2018
• Est. completion date: April 26, 2021

Study information

• Verified date: October 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.

Description:

This study includes a screening period of up to 35 days, a 16-week double-blind treatment period (Period A), and a 36-week double-blind treatment period (Period B).

Participants who meet eligibility criteria will be randomized at Baseline in a 2:2:1 ratio to one of 3 treatment groups: (1) risankizumab 150 mg, (2) risankizumab 300 mg, or (3) matching placebo. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and geographic region (Japan versus rest of world).

At Week 16, participants in the placebo group will be re-randomized in a 1:1 ratio to receive either risankizumab 150 mg or 300 mg for the remainder of the study. Participants originally randomized to the risankizumab 150 mg or 300 mg arms will stay on their previously-assigned treatment through the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: April 26, 2021
• Est. primary completion date: October 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• adults who are = 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old

• a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria

• moderate to severe AD at the Baseline Visit

• history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments

Exclusion Criteria:

• prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor

• concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Biological:
• Placebo
subcutaneous (SC) injection
• Risankizumab
subcutaneous (SC) injection

Locations

Country	Name	City	State
Australia	Skin Health Institute Inc /ID# 204779	Carlton	Victoria
Australia	Fremantle Dermatology /ID# 204784	Fremantle	Western Australia
Australia	North Eastern Health Specialists /ID# 204785	Hectorville	South Australia
Australia	St George Hospital /ID# 204780	Kogarah	New South Wales
Australia	Woden Dermatology /ID# 204778	Phillip	Australian Capital Territory
Australia	Veracity Clinical Research /ID# 204786	Woolloongabba	Queensland
Canada	Beacon Dermatology Inc /ID# 213003	Calgary	Alberta
Canada	Kirk Barber Research, CA /ID# 201046	Calgary	Alberta
Canada	University of Alberta Hospital - Division of Hematology /ID# 213008	Edmonton	Alberta
Canada	Dr. Wei Jing Loo Medicine Prof /ID# 208849	London	Ontario
Canada	Lynderm Research Inc. /ID# 201050	Markham	Ontario
Canada	Dre Angelique Gagne-Henley M.D. inc. /ID# 208189	Saint-Jerome	Quebec
Canada	Medicor Research Inc /ID# 211274	Sudbury	Ontario
Japan	Hamamatsu University Hospital /ID# 203270	Hamamatsu-shi	Shizuoka
Japan	Teikyo University Hospital /ID# 202884	Itabashi-ku	Tokyo
Japan	Nippon Medical School Musashi Kosugi Hospital /ID# 213961	Kawasaki-shi	Kanagawa
Japan	Kurume University Hospital /ID# 203139	Kurume-shi	Fukuoka
Japan	Nagaoka Red Cross Hospital /ID# 214140	Nagaoka-shi	Niigata
Japan	Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 213667	Nagoya-shi	Aichi
Japan	University of the Ryukyus Hospital /ID# 203974	Nakagami-gun	Okinawa
Japan	Osaka City University Hospital /ID# 203410	Osaka-shi	Osaka
Japan	Tokyo Medical University Hospital /ID# 203647	Shinjuku-ku	Tokyo
Japan	Tokyo Medical University Hospital /ID# 204101	Shinjuku-ku	Tokyo
Puerto Rico	Dr. Samuel Sanchez PSC /ID# 213117	Caguas
Puerto Rico	Cruz-Santana, Carolina, PR /ID# 213229	Carolina
Puerto Rico	Clinical Research Puerto Rico /ID# 213118	San Juan
United States	Cosmetic Dermatology of Orange County /ID# 205801	Anaheim	California
United States	Arlington Research Center, Inc /ID# 215899	Arlington	Texas
United States	MetroDerm ACC Research /ID# 205958	Atlanta	Georgia
United States	Oakland Hills Dermatology /ID# 217453	Auburn Hills	Michigan
United States	Tekton Research, Inc. /ID# 211558	Austin	Texas
United States	Duplicate_Great Lakes Research, Inc. /ID# 206447	Bay City	Michigan
United States	UAB Department of Dermatology /ID# 211561	Birmingham	Alabama
United States	Colorado Center for Dermatology, PLLC /ID# 216260	Centennial	Colorado
United States	Darst Dermatology /ID# 215100	Charlotte	North Carolina
United States	University Dermatology and Vein Clinic, LLC /ID# 210702	Darien	Illinois
United States	Dermatologic SurgiCenter /ID# 208972	Drexel Hill	Pennsylvania
United States	Psoriasis Treatment Center of Central New Jersey /ID# 203203	East Windsor	New Jersey
United States	Center for Dermatology Clinical Research /ID# 204950	Fremont	California
United States	Rivergate Dermatology & Skin Care Center /ID# 203372	Goodlettsville	Tennessee
United States	Dermdox Dermatology Centers, PC /ID# 212259	Hazleton	Pennsylvania
United States	Center for Clinical Studies - Houston (Binz) /ID# 203383	Houston	Texas
United States	RI SkinDoc /ID# 203417	Johnston	Rhode Island
United States	Skin Care Physicians of Georgia /ID# 213188	Macon	Georgia
United States	Dermatologists of Southwest Ohio, Inc /ID# 215104	Mason	Ohio
United States	Tulane University /ID# 203214	New Orleans	Louisiana
United States	Virginia Dermatology & Skin Cancer Center /ID# 210154	Norfolk	Virginia
United States	Unity Clinical Research /ID# 217461	Oklahoma City	Oklahoma
United States	Park Avenue Dermatology, PA /ID# 203378	Orange Park	Florida
United States	University of Pittsburgh MC /ID# 203296	Pittsburgh	Pennsylvania
United States	The Indiana Clinical Trials Center /ID# 211618	Plainfield	Indiana
United States	Derm Assoc of Plymouth Meeting /ID# 208925	Plymouth Meeting	Pennsylvania
United States	Oregon Derm & Res. Ctr /ID# 202880	Portland	Oregon
United States	Health Concepts /ID# 203205	Rapid City	South Dakota
United States	Skin Cancer and Dermatology Institute (SCDI) /ID# 213041	Reno	Nevada
United States	Dominion Medical Associates /ID# 212986	Richmond	Virginia
United States	DermAssociates /ID# 206189	Rockville	Maryland
United States	Integrative Skin Science and Research /ID# 212486	Sacramento	California
United States	Cosmetic Laser Dermatology /ID# 210560	San Diego	California
United States	Therapeutics Clinical Research /ID# 203422	San Diego	California
United States	Cognitive Clinical Trials /ID# 208895	Scottsdale	Arizona
United States	Acclaim Dermatology /ID# 213026	Sugar Land	Texas
United States	The Vancouver Clinic, INC. PS /ID# 202930	Vancouver	Washington
United States	Grekin Skin Institute /ID# 210485	Warren	Michigan
United States	Omega Medical Research /ID# 216022	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Japan,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Baseline and Week 16
Secondary	Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of = 2 Points at Week 16	Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) was used to assess the severity of AD based on lesion appearance on the following scale: 0 - Clear: No signs of AD; 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting; 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.	Baseline and Week 16
Secondary	Percentage of Participants Who Achieved a Reduction of = 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).	Baseline and Week 16
Secondary	Percent Change From Baseline in EASI Score at Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.	Baseline and Week 16
Secondary	Percent Change From Baseline in EASI Score at Week 28 and Week 52	EASI is used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected and the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling), scratching, and lichenification (lined skin, prurigo nodules).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.; LS means were calculated from an analysis of covariance (ANCOVA) model with Baseline, treatment and vIGA-AD categories in the model.	Baseline and Weeks 28 and 52
Secondary	Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.	Baseline and Weeks 28 and 52
Secondary	Percentage of Participants Who Achieved an EASI 50 Response at Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.; EASI 50 response is defined as at least a 50% reduction (improvement) from Baseline in EASI score.	Baseline and Week 16
Secondary	Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.; An EASI 50 response is defined as at least a 50% reduction (improvement) from Baseline in EASI score.	Baseline and Weeks 28 and 52
Secondary	Percentage of Participants Who Achieved an EASI 90 Response at Week 16	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.; An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.	Baseline, Week 16
Secondary	Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52	EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).; The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.; An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.	Baseline and Weeks 28 and 52
Secondary	Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of = 2 Points at Week 28 and Week 52	Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) was used to assess the severity of AD based on lesion appearance on the following scale: 0 - Clear: No signs of AD; 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting; 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.	Baseline and Weeks 28 and 52
Secondary	Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16	Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA. A negative change from Baseline indicates improvement.	Baseline and Week 16
Secondary	Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52	Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA. A negative change from Baseline indicates improvement.; LS means and standard errors were calculated from ANCOVA with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model.	Baseline and Weeks 28 and 52
Secondary	Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50) at Week 16	SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).	Baseline, Week 16
Secondary	Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52	SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).	Baseline and Weeks 28 and 52
Secondary	Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16	SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).; A SCORAD 75 response is defined as at least a 75% reduction (improvement) from Baseline in SCORAD score.	Baseline and Week 16
Secondary	Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52	SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).; A SCORAD 75 response is defined as at least a 75% reduction (improvement) from Baseline in SCORAD score.	Baseline and Weeks 28 and 52
Secondary	Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16	SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).; A SCORAD 90 response is defined as at least a 90% reduction (improvement) from Baseline in SCORAD score.	Baseline and Week 16
Secondary	Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52	SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).; A SCORAD 90 response is defined as at least a 90% reduction (improvement) from Baseline in SCORAD score.	Baseline and Weeks 28 and 52
Secondary	Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16	The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).; Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.	Week 16
Secondary	Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52	The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).; Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.	Weeks 28 and 52
Secondary	Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16	The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.; In this study, the CDLQI was administered to participants who were < 16 years old at Baseline.	Week 16
Secondary	Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52	The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.; In this study, the CDLQI was administered to participants who were < 16 years old at Baseline.	Weeks 28 and 52
Secondary	Percentage of Participants Who Achieved a Reduction in DLQI of = 4 Points From Baseline at Week 16 Among Those With a DLQI = 4 at Baseline	The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).; Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.; A change in DLQI score of at least 4 points is considered the minimum clinically important difference (MCID).	Baseline and Week 16
Secondary	Percentage of Participants Who Achieved a Reduction in DLQI of = 4 Points From Baseline at Week 28 and Week 52 Among Those With a DLQI = 4 at Baseline	The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).; Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.; A change in DLQI score of at least 4 points is considered the minimum clinically important difference (MCID).	Baseline and Weeks 28 and 52
Secondary	Change From Baseline in DLQI Score at Week 16	The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).; Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement.	Baseline and Week 16
Secondary	Change From Baseline in DLQI Score at Week 28 and Week 52	The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).; Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement.; LS means and standard errors were calculated from an ANCOVA model with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model.	Baseline and Weeks 28 and 52
Secondary	Change From Baseline in CDLQI Score at Week 16	The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A negative change from Baseline indicates improvement.; In this study, the CDLQI was administered to participants who were < 16 years old at the Baseline visit.	Baseline and Week 16
Secondary	Change From Baseline in CDLQI Score at Week 28 and Week 52	The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A negative change from Baseline indicates improvement.; In this study, the CDLQI was administered to participants who were < 16 years old at the Baseline visit.; LS means were calculated from ANCOVA with Baseline and treatment in the model.	Baseline and Weeks 28 and 52
Secondary	Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Change from Baseline was calculated from a rolling weekly average. A negative change from Baseline indicates improvement.	Baseline and Week 16
Secondary	Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Change from Baseline was calculated from a rolling weekly average. A negative change from Baseline indicates improvement.; LS means and standard errors were calculated from an ANCOVA with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model.	Baseline and Weeks 28 and 52
Secondary	Percentage of Participants Who Achieved a Reduction of = 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52	Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).	Baseline and Weeks 28 and 52