Efficacy and Safety Study as Add-on Therapy of SA237 to Treat NMO and NMOSD
Phase 3
Completed
- Conditions
- euromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)
- Registration Number
- JPRN-jRCT2080222347
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
The study met its primary endpoint, time to first relapse. Treatment with SA237 significantly reduced the risk of a PDR compared to placebo in patients on stable immunosuppressive baseline treatment. Consistent efficacy observed across most subgroups supports the robustness of the primary efficacy analysis, with a greater effect in patients with anti-AQP4-antibody-positive status.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 85
Inclusion Criteria
1. NMO or NMOSD
Exclusion Criteria
1. Pregnancy or lactation.
2. Evidence of other demyelinating disease or PML.
3. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method