NCT06413654

A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B001 Injection in Aquaporin-4 Antibody Positive Patients With Neuromyelitis Optica Spectrum Disorder

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of B001 injection in aquaporin-4 antibody positive patients with neuromyelitis optica spectrum disorder.

Conditions

• Neuromyelitis Optica Spectrum Disorders

Interventions

Type	Name	Description
DRUG	B001	The subjects will receive IV dose of B001 on Day 1 and Day 15 of RCP
OTHER	Placebo	The subjects will receive IV dose of placebo matched to B001 on Day 1 and Day 15 of the RCP

Timeline

• Start date: 2024-07-17
• Primary completion: 2027-10-31
• Completion: 2029-02-28
• First posted: 2024-05-14
• Last updated: 2025-01-27

Locations

51 sites across 1 country: China