drugset / Trial / NCT04660539
A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Satralizumab | Monoclonal antibody | 120 mg | Subcutaneous |
| Background | Azathioprine | Small molecule | 3 mg/kg | — |
| Background | Mycophenolate Mofetil | Small molecule | 3000 mg | — |