A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)
A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.
Inclusion Criteria:
Exclusion Criteria:
Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1.
Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
San Diego, California 92123, United States
Coral Springs, Florida 33071, United States
Monroe, Louisiana 71201, United States
Vitória, Espírito Santo 29055-450, Brazil
Salvador, Estado de Bahia 41820-020, Brazil
Belo Horizonte, Minas Gerais 30575-180, Brazil
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
Ribeirão Preto, São Paulo 14026-020, Brazil
São Paulo, São Paulo 05403-002, Brazil
Wuhan, Hubei 430022, China
Hangzhou, Zhejiang 310020, China
Frankfurt am Main, 60590, Germany
Bear Sheva, 8410101, Israel
Torino, 10126, Italy
Matsudo-shi, Chiba 271-0092, Japan
Asahikawa-shi, Hokkaido 070-8610, Japan
Obihiro-shi, Hokkaido 080-0013, Japan
Akashi-shi, Hyōgo 674-0068, Japan
Sakai-shi, Osaka 593-8324, Japan
Setagaya-ku, Tokyo 158-0097, Japan
Shinagawa-ku, Tokyo 141-8625, Japan
Gdansk, 80-280, Poland
Krakow, 30-002, Poland
Lodz, 91-495, Poland
Sosnowiec, 41-200, Poland
Wroclaw, 50-450, Poland
Cluj-Napoca, 400431, Romania