A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects 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.
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.
Inclusion Criteria:
Exclusion Criteria:
East Windsor, New Jersey 08520, United States
Goodlettsville, Tennessee 37072-2301, United States
Edmonton, Alberta T6G 2B7, Canada
Nagoya, Aichi-ken 455-8530, Japan
Kurume-shi, Fukuoka 830-0011, Japan
Kawasaki-shi, Kanagawa 211-8533, Japan
Nagaoka-shi, Niigata 940-2085, Japan
Nakagami-gun, Okinawa 903-0215, Japan
Itabashi-ku, Tokyo 173-8606, Japan
Shinjuku-ku, Tokyo 160-0023, Japan
Shinjuku-ku, Tokyo 160-0023, Japan