eligibility_summary
Eligibility: 2–<18 y, ≥15 kg, AQP4‑IgG+ NMOSD with ≥1 relapse in past year or ≥2 in 2 years. Exclude: interfering conditions or uncontrolled autoimmune disease, recent investigational therapy, hepatic/renal/hematologic issues or low B cells, prior alemtuzumab/TLI/BMT/T‑cell vax, recent rituximab/B‑cell depleters, IVIG, other immunosuppressants/biologics, or natalizumab, recent live/BCG vaccine or transfusion, active infection, immunodeficiency, HBV/HCV+, VZV‑IgG−, cancer (except cured skin), untreated TB.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Inebilizumab (humanized anti-CD19 IgG1 monoclonal antibody, IV), a B-cell–depleting immunotherapy. Mechanism of action: binds CD19 across the B-cell lineage (pre-B, naïve, memory, plasmablasts and some plasma cells) to deplete these cells via ADCC/CDC, reducing production of pathogenic aquaporin-4 (AQP4) IgG autoantibodies. Target cells/pathways: CD19+ B cells and plasmablasts, humoral/autoantibody pathway driving AQP4-IgG–mediated, complement-associated astrocyte injury in NMOSD. Study: Phase 2, open-label, single-arm PK/PD and safety in pediatric AQP4-IgG+ NMOSD.