eligibility_summary
Eligibility: Ages 12–<18 with atopic dermatitis ≥12 months (per AAD criteria), inadequate response to medium+ potency TCS (±TCI) or topicals inadvisable, EASI ≥12, vIGA-AD ≥3, ≥10% BSA at baseline. Exclude: biologics within 12 wks/5 half-lives, within 4 wks/5 half-lives systemic steroids, immunosuppressants, phototherapy, oral/topical JAKi, within 1 wk topical PDE4 inhibitors, other topical immunosuppressants (excl. TCS/TCI), or combo high/super-high potency steroids.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05633355 tests rocatinlimab (AMG 451/KHK4083), an immunotherapy: a human afucosylated IgG1 monoclonal antibody given subcutaneously (Q4W with an extra dose at Week 2) for 52 weeks in adolescents with moderate-to-severe atopic dermatitis. Mechanism of action: rocatinlimab targets OX40 (CD134), a costimulatory receptor upregulated on activated/memory T cells. It blocks OX40–OX40L signaling to reduce T‑cell activation, proliferation, survival, and cytokine production, and—due to afucosylation—enhances ADCC-mediated depletion of OX40+ T cells. Cells/pathways targeted: activated and memory CD4+ T helper cells (notably Th2, but also Th1/Th17), OX40/OX40L costimulatory pathway, downstream type 2 inflammatory axis implicated in AD (e.g., IL‑4/IL‑13/IL‑31). Single-arm, open-label, Phase 3 safety/efficacy study.