A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
A Phase 3, Open-label, 52-week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 Years With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Orbit)
The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.
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 agents within 1 week before day 1 pre-enrollment:
East Windsor, New Jersey 08520, United States
CABA, Buenos Aires C1027AAP, Argentina
Rosario, Santa Fe Province 2000, Argentina
São José dos Campos, São Paulo 12243-280, Brazil