NCT06068829

Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders

A Multicentric, Retrospective, Real-Word Study to Evaluate the Efficacy and Safety of Inebilizumab Compare With Rituximab in Neuromyelitis Optica Spectrum Disorders

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Feng Jinzhou · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the safety and efficacy of Inebilizumab and Rituximab in neuromyelitis optica spectrum disorders (NMOSD) patients.

Detailed description

Inebilizumab is a humanized anti-CD19 monoclonal antibody. CD19 is broadly expressed on B-lineage cells, particularly late-stage memory B-lymphocytes and plasma blasts. Inebilizumab depletes antibody-secreting plasmablasts and some plasma cells. Rituximab (RTX) is a chimeric anti-CD20 monoclonal antibody that promotes B-lymphocyte depletion through antibody-dependent cellular cytotoxicity (ADCC)/complement-dependent cytotoxicity (CDC), promotes an immunoregulatory T-lymphocyte phenotype, and activates neutrophil/macrophage phagocytosis. This is a retrospective, multicentre, real-world study which aims to compare Inebilizumab with RTX in neuromyelitis optica spectrum disorders patients. Eighty patients from 8 centres in China will be enrolled.

Conditions

• Neuromyelitis Optica Spectrum Disorders

Interventions

Type	Name	Description
DRUG	Inebilizumab	Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inebilizumab was given after IVMP.
DRUG	Rituximab(RTX)	RTX: 500mg IV on Day 1 and Day15. The first dose of RTX was given after IVMP.

Timeline

• Start date: 2023-10-20
• Primary completion: 2024-06-30
• Completion: 2025-06-30
• First posted: 2023-10-05
• Last updated: 2023-10-05