eligibility_summary
Eligibility: Completed end-of-treatment visit (Week 24 adults, Week 52 adolescents) in a rocatinlimab parent study (ROCKET-IGNITE/HORIZON/SHUTTLE/ASTRO/ORBIT/VOYAGER) within the past 28 days. ORBIT participants also need EASI ≥60% improvement at Week 52. Exclude if permanently stopped study drug for safety, protocol-stopping, or non-efficacy reasons in the parent study or at Screening/Day 1.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05882877 tests rocatinlimab (AMG 451/KHK4083), a subcutaneous human afucosylated IgG1 monoclonal antibody targeting OX40 (TNFRSF4). Mechanism: blocks OX40–OX40L costimulatory signaling and depletes OX40-expressing activated effector/memory T cells via enhanced ADCC, reducing pathogenic T-cell activation, survival, and cytokine production. Target cells/pathways: OX40+ CD4+ T cells (notably Th2, and also Th1/Th17) driving type 2–skewed inflammation in atopic dermatitis, modulation of the TNF receptor superfamily costimulatory pathway and downstream inflammatory cytokines. Comparator: placebo. Phase 3 maintenance design assesses long-term safety/efficacy with Q4W or Q8W dosing, plus withdrawal/resume and open-label arms in adults/adolescents with moderate-to-severe AD.