Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
| Condition | Systemic Lupus Erythematosus |
|---|---|
| Phase | Phase 2 |
| Sponsor | Novartis Pharmaceuticals |
| Status | Completed |
| Enrollment | 107 participants |
| Interventions | VAY736, VAY736 Placebo, CFZ533, CFZ533 Placebo |
| Start date | Dec 19, 2018 |
| Completion date | Jul 27, 2022 |
| Results posted | Jun 6, 2024 |
Summary
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 |
Open in BENITIONS View on ClinicalTrials.gov
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