eligibility_summary
Adults (≥18) with prurigo nodularis ≥3 months, avg daily itch score recorded over the last 7 days, ≥20 bilateral nodules on legs/arms/trunk, and inadequate response or inadvisability to medium‑or‑higher potency topical therapy. Exclude: other active skin/systemic diseases interfering (e.g., symptomatic AD), PN due to meds or neuro/psychiatric disease, recent systemic biologic immunotherapy (≤12 wks/5 half‑lives), or live/attenuated vaccination within 12 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Rocatinlimab (AMG 451), a subcutaneous monoclonal antibody immunotherapy, comparator: placebo. Mechanism of action: anti-OX40 (CD134) afucosylated IgG1 that blocks OX40/OX40L costimulatory signaling and depletes OX40-positive activated T cells via ADCC, reducing sustained T-cell activation and type 2 inflammation implicated in prurigo nodularis and itch. Target cells/pathways: OX40-expressing effector/memory CD4+ T cells (including skin-homing Th2 cells), OX40 (TNFRSF4)/OX40L pathway, downstream type 2 cytokine axis (e.g., IL-4, IL-13, IL-31) and related T-cell–mediated inflammatory pathways.