A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
NCT ID: NCT03706040
Last Updated: 2021-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2018-12-27
2021-04-26
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Placebo
subcutaneous (SC) injection
Risankizumab
subcutaneous (SC) injection
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.
Risankizumab
subcutaneous (SC) injection
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.
Risankizumab
subcutaneous (SC) injection
Interventions
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Placebo
subcutaneous (SC) injection
Risankizumab
subcutaneous (SC) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments
12 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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UAB Department of Dermatology /ID# 211561
Birmingham, Alabama, United States
Cognitive Clinical Trials /ID# 208895
Scottsdale, Arizona, United States
Cosmetic Dermatology of Orange County /ID# 205801
Anaheim, California, United States
Center for Dermatology Clinical Research /ID# 204950
Fremont, California, 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
Colorado Center for Dermatology, PLLC /ID# 216260
Centennial, Colorado, United States
Park Avenue Dermatology, PA /ID# 203378
Orange Park, Florida, United States
MetroDerm ACC Research /ID# 205958
Atlanta, Georgia, United States
Skin Care Physicians of Georgia /ID# 213188
Macon, Georgia, United States
University Dermatology and Vein Clinic, LLC /ID# 210702
Darien, Illinois, United States
The Indiana Clinical Trials Center /ID# 211618
Plainfield, Indiana, United States
Tulane University /ID# 203214
New Orleans, Louisiana, United States
DermAssociates /ID# 206189
Rockville, Maryland, United States
Oakland Hills Dermatology /ID# 217453
Auburn Hills, Michigan, United States
Duplicate_Great Lakes Research, Inc. /ID# 206447
Bay City, Michigan, United States
Grekin Skin Institute /ID# 210485
Warren, Michigan, United States
Skin Cancer and Dermatology Institute (SCDI) /ID# 213041
Reno, Nevada, United States
Psoriasis Treatment Center of Central New Jersey /ID# 203203
East Windsor, New Jersey, United States
Darst Dermatology /ID# 215100
Charlotte, North Carolina, United States
Dermatologists of Southwest Ohio, Inc /ID# 215104
Mason, Ohio, United States
Unity Clinical Research /ID# 217461
Oklahoma City, Oklahoma, United States
Oregon Derm & Res. Ctr /ID# 202880
Portland, Oregon, United States
Dermatologic SurgiCenter /ID# 208972
Drexel Hill, Pennsylvania, United States
Dermdox Dermatology Centers, PC /ID# 212259
Hazleton, Pennsylvania, United States
University of Pittsburgh MC /ID# 203296
Pittsburgh, Pennsylvania, United States
Derm Assoc of Plymouth Meeting /ID# 208925
Plymouth Meeting, Pennsylvania, United States
RI SkinDoc /ID# 203417
Johnston, Rhode Island, United States
Omega Medical Research /ID# 216022
Warwick, Rhode Island, United States
Health Concepts /ID# 203205
Rapid City, South Dakota, United States
Rivergate Dermatology & Skin Care Center /ID# 203372
Goodlettsville, Tennessee, United States
Arlington Research Center, Inc /ID# 215899
Arlington, Texas, United States
Tekton Research, Inc. /ID# 211558
Austin, Texas, United States
Center for Clinical Studies - Houston (Binz) /ID# 203383
Houston, Texas, United States
Acclaim Dermatology /ID# 213026
Sugar Land, Texas, United States
Virginia Dermatology & Skin Cancer Center /ID# 210154
Norfolk, Virginia, United States
Dominion Medical Associates /ID# 212986
Richmond, Virginia, United States
The Vancouver Clinic, INC. PS /ID# 202930
Vancouver, Washington, United States
Woden Dermatology /ID# 204778
Phillip, Australian Capital Territory, Australia
St George Hospital /ID# 204780
Kogarah, New South Wales, Australia
Veracity Clinical Research /ID# 204786
Woolloongabba, Queensland, Australia
North Eastern Health Specialists /ID# 204785
Hectorville, South Australia, Australia
Skin Health Institute Inc /ID# 204779
Carlton, Victoria, Australia
Fremantle Dermatology /ID# 204784
Fremantle, Western Australia, Australia
Kirk Barber Research, CA /ID# 201046
Calgary, Alberta, Canada
Beacon Dermatology Inc /ID# 213003
Calgary, Alberta, Canada
University of Alberta Hospital - Division of Hematology /ID# 213008
Edmonton, Alberta, Canada
Medicor Research Inc /ID# 211274
Greater Sudbury, Ontario, 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-Jérôme, Quebec, Canada
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 213667
Nagoya, Aichi-ken, Japan
Kurume University Hospital /ID# 203139
Kurume-shi, Fukuoka, Japan
Nippon Medical School Musashi Kosugi Hospital /ID# 213961
Kawasaki-shi, Kanagawa, Japan
Nagaoka Red Cross Hospital /ID# 214140
Nagaoka-shi, Niigata, Japan
University of the Ryukyus Hospital /ID# 203974
Nakagami-gun, Okinawa, Japan
Osaka City University Hospital /ID# 203410
Osaka, Osaka, Japan
Hamamatsu University Hospital /ID# 203270
Hamamatsu, Shizuoka, Japan
Teikyo University Hospital /ID# 202884
Itabashi-ku, Tokyo, Japan
Tokyo Medical University Hospital /ID# 203647
Shinjuku-ku, Tokyo, Japan
Tokyo Medical University Hospital /ID# 204101
Shinjuku-ku, Tokyo, Japan
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, , Puerto Rico
Countries
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References
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Tyring SK, Rich P, Tada Y, Beeck S, Messina I, Liu J, Huang X, Shumack S. Risankizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2023 Feb;13(2):595-608. doi: 10.1007/s13555-022-00876-x. Epub 2023 Jan 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-002203-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-813
Identifier Type: -
Identifier Source: org_study_id