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

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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis
• Intervention / Treatment: Biological: Placebo; Biological: Risankizumab

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Woden Dermatology /ID# 204778
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital /ID# 204780
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research /ID# 204786
  • South Australia
    • Hectorville, South Australia, Australia, 5073
      • North Eastern Health Specialists /ID# 204785
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc /ID# 204779
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Dermatology /ID# 204784
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2G 1B1
      • Kirk Barber Research, CA /ID# 201046
    • Calgary, Alberta, Canada, T3E 0B2
      • Beacon Dermatology Inc /ID# 213003
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital - Division of Hematology /ID# 213008
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Dr. Wei Jing Loo Medicine Prof /ID# 208849
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc. /ID# 201050
    • Sudbury, Ontario, Canada, P3A 1W8
      • Medicor Research Inc /ID# 211274
  • Quebec
    • Saint-Jerome, Quebec, Canada, J7Z 7E2
      • Dre Angelique Gagne-Henley M.D. inc. /ID# 208189
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 455-8530
      • Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 213667
  • Fukuoka
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital /ID# 203139
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 211-8533
      • Nippon Medical School Musashi Kosugi Hospital /ID# 213961
  • Niigata
    • Nagaoka-shi, Niigata, Japan, 940-2085
      • Nagaoka Red Cross Hospital /ID# 214140
  • Okinawa
    • Nakagami-gun, Okinawa, Japan, 903-0215
      • University of the Ryukyus Hospital /ID# 203974
  • Osaka
    • Osaka-shi, Osaka, Japan, 545-8586
      • Osaka City University Hospital /ID# 203410
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital /ID# 203270
  • Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8606
      • Teikyo University Hospital /ID# 202884
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital /ID# 203647
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital /ID# 204101
• Puerto Rico
  • Caguas, Puerto Rico, 00727
    • Dr. Samuel Sanchez PSC /ID# 213117
  • Carolina, Puerto Rico, 00985
    • Cruz-Santana, Carolina, PR /ID# 213229
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico /ID# 213118
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Department of Dermatology /ID# 211561
  • Arizona
    • Scottsdale, Arizona, United States, 85258-4446
      • Cognitive Clinical Trials /ID# 208895
  • California
    • Anaheim, California, United States, 92807-4780
      • Cosmetic Dermatology of Orange County /ID# 205801
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research /ID# 204950
    • Sacramento, California, United States, 95815-4500
      • Integrative Skin Science and Research /ID# 212486
    • San Diego, California, United States, 92121-2119
      • Cosmetic Laser Dermatology /ID# 210560
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research /ID# 203422
  • Colorado
    • Centennial, Colorado, United States, 80111-1724
      • Colorado Center for Dermatology, PLLC /ID# 216260
  • Florida
    • Orange Park, Florida, United States, 32073
      • Park Avenue Dermatology, PA /ID# 203378
  • Georgia
    • Atlanta, Georgia, United States, 30342-1418
      • MetroDerm ACC Research /ID# 205958
    • Macon, Georgia, United States, 31217
      • Skin Care Physicians of Georgia /ID# 213188
  • Illinois
    • Darien, Illinois, United States, 60561
      • University Dermatology and Vein Clinic, LLC /ID# 210702
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center /ID# 211618
  • Louisiana
    • New Orleans, Louisiana, United States, 70112-2699
      • Tulane University /ID# 203214
  • Maryland
    • Rockville, Maryland, United States, 20850
      • DermAssociates /ID# 206189
  • Michigan
    • Auburn Hills, Michigan, United States, 48326-4600
      • Oakland Hills Dermatology /ID# 217453
    • Bay City, Michigan, United States, 48602
      • Duplicate_Great Lakes Research, Inc. /ID# 206447
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute /ID# 210485
  • Nevada
    • Reno, Nevada, United States, 89052
      • Skin Cancer and Dermatology Institute (SCDI) /ID# 213041
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey /ID# 203203
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Darst Dermatology /ID# 215100
  • Ohio
    • Mason, Ohio, United States, 45040-4520
      • Dermatologists of Southwest Ohio, Inc /ID# 215104
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Unity Clinical Research /ID# 217461
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Derm & Res. Ctr /ID# 202880
  • Pennsylvania
    • Drexel Hill, Pennsylvania, United States, 19026-1101
      • Dermatologic SurgiCenter /ID# 208972
    • Hazleton, Pennsylvania, United States, 18201
      • Dermdox Dermatology Centers, PC /ID# 212259
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh MC /ID# 203296
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Derm Assoc of Plymouth Meeting /ID# 208925
  • Rhode Island
    • Johnston, Rhode Island, United States, 02910-4423
      • RI SkinDoc /ID# 203417
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research /ID# 216022
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts /ID# 203205
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072-2301
      • Rivergate Dermatology & Skin Care Center /ID# 203372
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc /ID# 215899
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc. /ID# 211558
    • Houston, Texas, United States, 77004-8097
      • Center for Clinical Studies - Houston (Binz) /ID# 203383
    • Sugar Land, Texas, United States, 77479-2645
      • Acclaim Dermatology /ID# 213026
  • Virginia
    • Norfolk, Virginia, United States, 23502-2233
      • Virginia Dermatology & Skin Cancer Center /ID# 210154
    • Richmond, Virginia, United States, 23219
      • Dominion Medical Associates /ID# 212986
  • Washington
    • Vancouver, Washington, United States, 98664
      • The Vancouver Clinic, INC. PS /ID# 202930

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants randomized to receive placebo for 16 weeks in Period A followed by either risankizumab 150 mg or risankizumab 300 mg for 36 weeks in Period B.	Biological: Placebo; subcutaneous (SC) injection; Biological: Risankizumab; subcutaneous (SC) injection; Other Names: BI 655066; ABBV-066
Experimental: Risankizumab 150 mg; Participants randomized to receive risankizumab 150 mg for 16 weeks in Period A followed by risankizumab 150 mg for 36 weeks in Period B.	Biological: Risankizumab; subcutaneous (SC) injection; Other Names: BI 655066; ABBV-066
Experimental: Risankizumab 300 mg; Participants randomized to receive risankizumab 300 mg for 16 weeks in Period A followed by risankizumab 300 mg for 36 weeks in Period B.	Biological: Risankizumab; subcutaneous (SC) injection; Other Names: BI 655066; ABBV-066

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2018
• Primary Completion (Actual): October 28, 2020
• Study Completion (Actual): April 26, 2021

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Atopic dermatitis, Atopic dermatitis (atopic eczema)
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: M16-813; 2021-002203-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No