Clinical Trial

FcRn Antagonists (Efgartigimod) for Acute NMOSD Attack

Study acronym: FACT
Unknown Phase 2
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Record status
This record was last updated July 11, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06497374
Lead Sponsor Tianjin Medical University General Hospital
Conditions Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, NMO Spectrum Disorder
Enrollment 63 participants
Start Date 2024-07-05
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-07-11