A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
The co-primary objectives of the study are to:
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 Francisco, California 94115, United States
Tampa, Florida 33612, United States
Warwick, Rhode Island 02886, United States
São Bernardo do Campo, São Paulo 09715-090, Brazil
São José dos Campos, São Paulo 12243-280, Brazil
Halle, 06120, Germany
Matsudo-shi, Chiba 271-0092, Japan
Narita-shi, Chiba 286-8520, Japan
Kawasaki-shi, Kanagawa 216-8511, Japan
Sagamihara-shi, Kanagawa 252-0392, Japan
Habikino-shi, Osaka 583-8588, Japan
Sakai-shi, Osaka 593-8324, Japan
Minato-ku, Tokyo 108-0014, Japan
Shinagawa-ku, Tokyo 142-8666, Japan
Shinjuku-ku, Tokyo 161-8521, Japan
Toshima-ku, Tokyo 170-0002, Japan
Takaoka-shi, Toyama 933-0871, Japan
Lodz, 91-495, Poland
Bucheon-si, Gyeonggi-do, 14584, South Korea
Seongnam-si, Gyeonggi-do, 13620, South Korea
Suwon-si, Gyeonggi-do, 16499, South Korea