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

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 7 months later May 31, 2026 → Dec 31, 2027
See other at-risk trials from Bio-Thera Solutions

Record History

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  1. Primary and study completion pushed from May 31, 2026 to Dec 31, 2027
    • Eligibility criteria expanded, about 29 words
    • Site details revised at 10 of 45 sites
  2. Primary completion date: May 31, 2025 to May 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 45 of 45 sites
    v3
  3. Study Identification, Study Status, Oversightv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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) .
Trial Details
NCT Number NCT06044350
Lead Sponsor Bio-Thera Solutions
Conditions
(from sponsor)		 Optic Neuromyelitis Spectrum Disease
Enrollment 162 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov