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

NCT06413654 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-05-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

    collaborator INDUSTRY

  • Shanghai Jiaolian Drug Research and Development Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2027-10-31
Completion
2029-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06413654 on ClinicalTrials.gov