Psoriasis Clinical Trial
A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
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.
Full 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.
Eligibility Criteria
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
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There are 64 Locations for this study
Birmingham Alabama, 35233, United States
Scottsdale Arizona, 85258, United States
Anaheim California, 92807, United States
Fremont California, 94538, United States
Sacramento California, 95815, United States
San Diego California, 92121, United States
San Diego California, 92123, United States
Centennial Colorado, 80111, United States
Orange Park Florida, 32073, United States
Atlanta Georgia, 30342, United States
Macon Georgia, 31217, United States
Darien Illinois, 60561, United States
Plainfield Indiana, 46168, United States
New Orleans Louisiana, 70112, United States
Rockville Maryland, 20850, United States
Auburn Hills Michigan, 48326, United States
Bay City Michigan, 48602, United States
Warren Michigan, 48088, United States
Reno Nevada, 89052, United States
East Windsor New Jersey, 08520, United States
Charlotte North Carolina, 28277, United States
Mason Ohio, 45040, United States
Oklahoma City Oklahoma, 73118, United States
Portland Oregon, 97210, United States
Drexel Hill Pennsylvania, 19026, United States
Hazleton Pennsylvania, 18201, United States
Pittsburgh Pennsylvania, 15260, United States
Plymouth Meeting Pennsylvania, 19462, United States
Johnston Rhode Island, 02910, United States
Warwick Rhode Island, 02886, United States
Rapid City South Dakota, 57702, United States
Goodlettsville Tennessee, 37072, United States
Arlington Texas, 76011, United States
Austin Texas, 78745, United States
Houston Texas, 77004, United States
Sugar Land Texas, 77479, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23219, United States
Vancouver Washington, 98664, United States
Phillip Australian Capital Territory, 2606, Australia
Kogarah New South Wales, 2217, Australia
Woolloongabba Queensland, 4102, Australia
Hectorville South Australia, 5073, Australia
Carlton Victoria, 3053, Australia
Fremantle Western Australia, 6160, Australia
Calgary Alberta, T2G 1, Canada
Calgary Alberta, T3E 0, Canada
Edmonton Alberta, T6G 2, Canada
London Ontario, N6H 5, Canada
Markham Ontario, L3P 1, Canada
Sudbury Ontario, P3A 1, Canada
Saint-Jerome Quebec, J7Z 7, Canada
Nagoya-shi Aichi, 455-8, Japan
Kurume-shi Fukuoka, 830-0, Japan
Kawasaki-shi Kanagawa, 211-8, Japan
Nagaoka-shi Niigata, 940-2, Japan
Nakagami-gun Okinawa, 903-0, Japan
Osaka-shi Osaka, 545-8, Japan
Hamamatsu-shi Shizuoka, 431-3, Japan
Itabashi-ku Tokyo, 173-8, Japan
Shinjuku-ku Tokyo, 160-0, Japan
Shinjuku-ku Tokyo, 160-0, Japan
Caguas , 00727, Puerto Rico
Carolina , 00985, Puerto Rico
San Juan , 00909, Puerto Rico
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