A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
The coprimary 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:
Monroe, Louisiana 71201, United States
CABA, Buenos Aires C1027AAP, Argentina
Rosario, Santa Fe Province 2000, Argentina
Sofia, 1463, Bulgaria
Coburg, Ontario K9A 4J9, Canada
Wuhan, Hubei 430022, China
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310016, China
Hangzhou, Zhejiang 310020, China
Merzing, 66663, Germany
LAquila, 67100, Italy
Rozzano MI, 20089, Italy
Obihiro-shi, Hokkaido 080-0013, Japan
Kawasaki-shi, Kanagawa 211-0063, Japan
Adachi-ku, Tokyo 120-0034, Japan
Setagaya-ku, Tokyo 158-0097, Japan
Shinagawa-ku, Tokyo 141-8625, Japan
Shinjuku-ku, Tokyo 169-0075, Japan
Krakow, 30-002, Poland
Cluj-Napoca, 400431, Romania