drugset / Trial / NCT04660539

A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

NCT04660539

Phase 3 Completed 119 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 and BN40900. Participants will receive satralizumab as monotherapy or in combination with one of the following background immunosuppressive treatments: azathioprine (AZA), mycophenolate mofetil (MMF), or oral corticosteroids.

Timeline

Start
2021-03-02
Primary completion
2024-05-28
Completion
2024-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Satralizumab Monoclonal antibody 120 mg Subcutaneous
Background Azathioprine Small molecule 3 mg/kg
Background Mycophenolate Mofetil Small molecule 3000 mg

Indications