Clinical Trial

A Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated December 8, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a phase II/III multicenter, randomized, double-blind, placebo-controlled study, to investigate the efficacy and safety of BAT4406F injection in patients with neuromyelitis optica lineage disease (NMOSD) who are positive for aquaporin 4 antibody (AQP4-IgG) .
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-09-12; most recent amendment 2025-12-01.
Status change: Recruiting → Active, Not Recruiting 2025-12-01
Trial Details
NCT Number NCT06044350
Lead Sponsor Bio-Thera Solutions
Conditions Optic Neuromyelitis Spectrum Disease
Enrollment 162 participants
Start Date 2023-08-01
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-08