eligibility_summary
Adults 18–65 with AD ≥6 months, EASI ≥8, IGA ≥3, ≥7% BSA, inadequate response to medium+ TCS. Exclude: prior rocatinlimab/recent investigational Rx, recent systemic immunosuppressants, certain topicals/phototherapy, CYP inducers/inhibitors or CYP probe drug contraindication, substance abuse/heavy smoking, poor CYP2C9/2C19/2D6 metabolizers, serious infection/immunodeficiency, HBV/HCV/HIV, cancer, helminths, suicidality/major psych, pregnancy/breastfeeding or poor contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Rocatinlimab (AMG 451), a human monoclonal antibody against OX40 (CD134), plus a CYP “cocktail” of probe substrates: caffeine (methylxanthine, CYP1A2), metoprolol (beta1‑blocker, CYP2D6), midazolam (benzodiazepine, CYP3A4), warfarin (vitamin K antagonist, CYP2C9, with vitamin K), and omeprazole (proton pump inhibitor, CYP2C19). Mechanisms: Rocatinlimab blocks OX40–OX40L T‑cell costimulation and can deplete OX40+ activated T cells, aiming to reduce type‑2 inflammation in atopic dermatitis. Cells/pathways targeted: immune—activated CD4+ T cells (especially Th2) via the OX40 pathway, metabolic—hepatic CYP450 enzymes CYP1A2, CYP2D6, CYP3A4, CYP2C9, and CYP2C19 to evaluate drug–drug interaction potential.