Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)

Summary

The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD.

Timeline

Start

2022-04-07

Primary completion

2026-12-15

Completion

2026-12-15

Publications

• Jia D, Wang H, Jiang W, Shen Y, Guo J, Zhao D, Zhang M, Meng H, Xue H, Song Y, Yao Q, Xie N, Zhang C. A novel recombinant anti-cluster of differentiation 20 humanized monoclonal antibody (B001) for the treatment of neuromyelitis optica spectrum disorder: a phase 1, multicenter randomized, double-blind trial. Front Immunol. 2026 Apr 16;17:1676908. doi: 10.3389/fimmu.2026.1676908. eCollection 2026.

Drugs

Indications