eligibility_summary
Eligible: ≥12 years, AD per AAD ≥12 months, inadequate response to medium/high-potency TCS ± TCI, vIGA-AD ≥3, EASI ≥16, and ≥10% BSA (all at screening and pre-randomization). Exclude: recent biologics (≤12 wks or ≤5 half-lives), systemic steroids, non-biologic systemic immunosuppressants, or oral/topical JAK inhibitors within 5 half-lives, topical PDE4 inhibitors, other topical immunosuppressants (not TCS/TCI), or combos within 1 week.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Rocatinlimab (AMG 451), a subcutaneous, humanized IgG1 monoclonal antibody immunotherapy against OX40 (CD134), self-administered via prefilled syringe or autoinjector at two dose levels for 52 weeks. Mechanism of action: Inhibits the OX40–OX40L T‑cell costimulatory pathway and depletes OX40+ activated T cells via Fc-enhanced ADCC, reducing activation, survival, and tissue homing of pathogenic effector/memory T cells. Target cells/pathways: Activated CD4+ T cells (particularly Th2-skewed) in skin, modulation of type 2 inflammatory signaling and cytokines (e.g., IL‑4, IL‑13, IL‑22, IL‑31).