NCT05154734

Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders

Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders (BEAT NMO)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Tianjin Medical University General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Belimumab (Benlysta ®) is a human immunoglobulin G1λ monoclonal antibody that inhibits B-cell survival and differentiation by neutralizing soluble B lymphocyte stimulator. Belimumab may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clinical trials may be needed to observe its efficacy and safety.

Detailed description

The investigators primarily aim to observe the number of attacks from initiation of belimumab treatment. The secondary outcomes are to determine: The safety profile of belimumab in participants with NMO and whether belimumab improves Expanded Disability Status Scale (EDSS), et al.

Conditions

• NMO Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Belimumab	Belimumab will be intravenously administered with a dose of 10mg/kg on Days 0,14 and28, then every 28 days until week 48, with a final evaluation at week 52.

Timeline

• Start date: 2021-12-12
• Primary completion: 2023-06-30
• Completion: 2024-04-09
• First posted: 2021-12-13
• Last updated: 2024-10-16

Locations

1 site across 1 country: China