eligibility_summary
Adults 18–75 with IPND 2015 NMOSD, AQP4-IgG+ by CBA, acute optic neuritis/myelitis >24h, EDSS nadir 2.5–7.5 with ≥0.5 change, MRI new/enhancing lesions, stable treatment ≥3 months, agree to stop immunosuppression. Exclude: other core symptoms, severe/ventilation-risk attack, IgG ≤6 g/L or low B cells, recent IVMP/IVIG/PLEX/vaccines/other immunomodulators, allergy/contra to drug/contrast/steroids, active infection/TB, HBV/HCV+ with recent live vaccine, MRI unable, other vision-affecting eye disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 RCT in acute AQP4-IgG+ NMOSD tests: 1) efgartigimod alfa + high‑dose IV methylprednisolone (IVMP), 2) IVMP alone, 3) efgartigimod alone, inebilizumab may start after week 4 for relapse prevention. Efgartigimod alfa: biologic IgG1 Fc fragment, FcRn antagonist that blocks neonatal Fc receptor–mediated IgG recycling, accelerating IgG catabolism and lowering pathogenic AQP4‑IgG, aiming to reduce complement-driven astrocyte injury. IVMP: corticosteroid, glucocorticoid receptor agonist that suppresses proinflammatory cytokine transcription, leukocyte activation, and trafficking. Inebilizumab: anti‑CD19 monoclonal antibody depleting B‑lineage cells (incl. plasmablasts), reducing autoantibody production. Targets/pathways: FcRn–IgG recycling, CD19+ B cells/plasmablasts, glucocorticoid receptor signaling in immune cells.