Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
| 대상 질환 | Systemic Lupus Erythematosus |
|---|---|
| 임상 단계 | 2상 |
| 스폰서 | Novartis Pharmaceuticals |
| 상태 | 완료 |
| 참여자 수 | 107 명 |
| 중재(약물) | VAY736, VAY736 Placebo, CFZ533, CFZ533 Placebo |
| 시작일 | 2018년 12월 19일 |
| 완료일 | 2022년 7월 27일 |
| 결과 공개일 | 2024년 6월 6일 |
요약
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 |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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