eligibility_summary
Eligible: ages 12–<18 with AD ≥12 months, weight ≥40 kg, inadequate response to medium/high‑potency TCS (±TCI), EASI ≥12 at screening and ≥16 at Day 1, vIGA‑AD ≥3, ≥10% BSA, pruritus NRS ≥4. Exclude if recent: biologics (≤12 wks/5 half‑lives), in past 4 wks/5 half‑lives: systemic steroids, non‑biologic immunosuppressants, phototherapy, oral/topical JAKi, in past 1 wk: any TCS, TCI, topical PDE4 inhibitors, other topical immunosuppressants.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, double-blind study in adolescents with moderate-to-severe atopic dermatitis testing rocatinlimab (AMG 451, KHK4083) vs placebo, with optional background topical corticosteroids/calcineurin inhibitors. Rocatinlimab is a human afucosylated IgG1 monoclonal antibody (subcutaneous) that targets OX40 (TNFRSF4) on activated T cells. Mechanism: blocks OX40–OX40L co-stimulatory signaling and depletes OX40+ T cells via ADCC, reducing T-cell activation, survival, and memory. Cells/pathways targeted: OX40-expressing effector and memory T cells—particularly Th2 cells driving type 2 inflammation in AD—attenuating downstream cytokine signaling (e.g., IL-4, IL-13, IL-31) and broader T-cell inflammatory circuits.