drugset / Trial / NCT06497374

FcRn Antagonists (Efgartigimod) for Acute NMOSD Attack

NCT06497374

Phase 2 Not yet recruiting 63 enrolled Tianjin Medical University General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

NMOSD is an autoimmune disease of the central nervous system that predominantly affects the spinal cord and optic nerves. The objectives of this study are to assess the efficacy and safety of FcRn antagonists (efgartigmod) for treatment of patients with neuromyelitis optica spectrum disorders during acute phase who are anti-aquaporin-4 (AQP4) antibody-positive. The potential of efgartigimod, an IgG1 Fc fragment that competes with IgG for FcRn binding, thereby lowering IgG levels, warrants further investigation as a treatment for acute neuromyelitis optica spectrum disorders attacks. This study aims to evaluate the therapeutic potential of efgartigmod in acute NMOSD attack.

Timeline

Start
2024-07-05
Primary completion
2025-12-31
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Efgartigimod Alfa Protein / enzyme biologic 10 mg/kg Intravenous
Background Methylprednisolone Other / unclassified 1000 mg Intravenous