JPRN-jRCT2080222347已完成3 期
A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with neuromyelitis optica (NMO) and NMO spectrum disorder (NMOSD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 85
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •1. NMO or NMOSD
排除标准
- •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.
研究者
相似试验
已完成
2 期
A phase 2 phosphate binder-combination study of KHK7791 in hyperphosphatemia patientsHyperphosphatemia patients on hemodialysisJPRN-jRCT2080224556Kyowa Kirin Co., Ltd.133
已完成
2 期
A Study of Brexpiprazole in Patients With Major Depressive DisorderMajor depressive disorderJPRN-jRCT2080223986Otsuka Pharmaceutical Co., Ltd.740
已完成
2 期
A Randomized, Double-blind, Cross-over Study of S-600918 in Participants with Sleep Apnea SyndromeSleep Apnea SyndromeJPRN-jRCT2080225317SHIONOGI & CO., LTD.33
已完成
不适用
Prospective clinical trial to evaluate efficacy, safety and usability of nanoemulsion cyclosporin 0.05%, emulsion cyclosporin 0.05% and diquafosol 3% in dry eye patientsDiseases of the eye and adnexaKCT0002180The Catholic University of Korea, Yeouido St. Mary's Hospital227
已完成
不适用
A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel diseaseInflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease)JPRN-jRCTs031180415Ishikawa Dai7