NCT06497374

FcRn Antagonists (Efgartigimod) for Acute NMOSD Attack

FcRn Antagonists (Efgartigimod) for Acute Neuromyelitis Optica Spectrum Disorders (NMOSD) Attack: a Phase 2, Randomized Controlled Trial.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Tianjin Medical University General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder
• NMO Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Efgartigimod Alfa Injection	Efgartigimod+IVMP; IVMP; Efgartigimod
DRUG	High-dose intravenous methylprednisolone	Efgartigimod+IVMP; IVMP; Efgartigimod

Timeline

• Start date: 2024-07-05
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-07-11
• Last updated: 2024-07-11