A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Longterm Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

The study is designed to confirm if rocatinlimab is safe and effective for the treatment of patients with moderate-to-severe AD (atopic dermatitis) who have not responded to topical treatments (applied externally on the skin) or other treatments, and whether it is tolerated well, and whether it causes any side effects. It will also help to establish the beneficial impact of the treatment with rocatinlimab on the related outcomes including skin itching, skin pain, sleep loss, and impaired quality of life in participants with AD. Rocatinlimab is a protein-based drug designed specifically to attach and prevent the function of a protein named OX40 on cells that are involved in inflammation and may be another treatment option for inflammatory skin diseases. Rocatinlimab or placebo (a substance that does not have any medicine in it but looks like the drug being tested; researchers use a placebo to decide if the study drug works better than no treatment at all) will be given by injection just under the skin (subcutaneously) every 4 weeks (Q4W) for 100 weeks of treatment period for adult studies or 72 weeks of treatment period for adolescent studies. (Adolescents will not be recruited at PAH).