eligibility_summary
Eligible: adults ≥18 with consent who completed ≥2 years in N‑MOmentum open‑label or are starting inebilizumab at site. Contraception: women of childbearing potential use highly effective methods during treatment +6 months, men use condom+spermicide for 3 months post‑dose, extra method in Czech Republic, same for sterilized men without proven azoospermia. Exclude: high‑risk, recent B‑cell depleters, allergy/anaphylaxis, infection (incl HBV/TB), PML, severe immunodef, active malignancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Inebilizumab (UPLIZNA), a humanized IgG1 monoclonal antibody immunotherapy that targets CD19 to deplete B cells. Mechanism of action: binds CD19 expressed from pre‑B cells through plasmablasts (and some short‑lived plasma cells), triggering antibody-dependent cellular cytotoxicity and complement-mediated lysis, broadly reducing B‑cell populations and pathogenic AQP4-IgG production in NMOSD. Additional intervention: periodic blood tests for safety/PK/PD monitoring. Targets (cells/pathways): CD19+ B cells, plasmablasts, some plasma cells, humoral autoimmunity pathways, circulating immunoglobulins (IgG, IgM), B‑cell counts/reconstitution, antidrug antibodies. Study focus: long-term safety and effects on immunoglobulins and B‑cell dynamics during treatment and after discontinuation. Phase 4, open-label, single-group.