Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
| 适应症 | Systemic Lupus Erythematosus |
|---|---|
| 分期 | 2期 |
| 申办方 | Novartis Pharmaceuticals |
| 状态 | 已完成 |
| 受试者人数 | 107 人 |
| 干预（药物） | VAY736, VAY736 Placebo, CFZ533, CFZ533 Placebo |
| 开始日期 | 2018年12月19日 |
| 完成日期 | 2022年7月27日 |
| 结果公布日 | 2024年6月6日 |
摘要
This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 (iscalimab) in patients with systemic lupus erythematosus (SLE) to enable further development of these compounds as treatment in this disease population
Percentage of Participants With SLE Responder Index (SRI)-4 Response Status at Week 29 With Reduced Steroid Dose Maintained Between Weeks 17 and 29
| Cohort 1 VAY736 | 15 Participants |
|---|---|
| Cohort 1 VAY736 Placebo | 3 Participants |
| Cohort 2 CFZ533 | 8 Participants |
| Cohort 2 CFZ533 Placebo | 6 Participants |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
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