eligibility_summary
Inclusion: Adults (≥18) with AD per AAD for ≥12 months, inadequate response to medium+ potency TCS (±TCI), EASI≥16, vIGA-AD≥3, ≥10% BSA, worst pruritus NRS≥4. Exclusion: biologics within 12 weeks/5 half-lives, within 4 weeks/5 half-lives: systemic corticosteroids, nonbiologic systemic immunosuppressants, phototherapy, JAK inhibitors, within 1 week: TCS, TCI, topical PDE4 inhibitors, other/combination topical immunosuppressants.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Rocatinlimab (AMG 451/KHK4083) plus background topical therapy vs placebo plus topical therapy. Rocatinlimab is a subcutaneous anti‑OX40 (TNFRSF4) monoclonal antibody (IgG1, immunotherapy). Mechanism: blocks OX40–OX40L costimulation and depletes OX40+ activated T cells via Fc‑mediated cytotoxicity, reducing pathogenic T‑cell responses (notably Th2) and their cytokines in AD. Background therapies: topical corticosteroids (glucocorticoid receptor agonists, broad anti‑inflammatory gene suppression) and topical calcineurin inhibitors such as tacrolimus/pimecrolimus (calcineurin/NFAT pathway blockade, inhibits T‑cell activation). Targets/pathways: activated OX40+ T cells (Th2>Th1/Th17), T‑cell/APC costimulatory signaling via OX40, NFAT signaling (via TCI), and broad inflammatory pathways via GR (steroids).