eligibility_summary
Adults (≥18) with AQP4-IgG–positive NMOSD per Chinese guidelines, EDSS ≤7.5, ≥1 relapse needing rescue in past year or ≥2 in past 2 years, consent and effective contraception. Exclude prior CD52 mAbs/lymphoid irradiation/BM transplant/T-cell vaccination, recent B-cell depleters, IVIG, immunosuppressants/biologics, high-dose steroids, recent trials, severe allergies, substance abuse, pregnancy, significant infections, immunodeficiency/HBV/HCV, malignancy (except cured skin), other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 4, open-label, single-arm study in Chinese adults with AQP4-IgG–positive NMOSD testing inebilizumab (IV 300 mg). Drug/intervention: Inebilizumab is a humanized anti-CD19 monoclonal antibody (biologic) that depletes B cells via antibody-dependent cellular cytotoxicity and complement. Mechanism: Broad depletion of the CD19+ B-cell lineage (pre-B, naive, memory, plasmablasts and some plasma cells) reduces production of pathogenic anti–aquaporin-4 autoantibodies. Targets/pathways: CD19+ B cells, humoral autoimmunity and complement-mediated astrocyte injury.