drugset / Trial / NCT03656562

Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients

NCT03656562

Phase 2 Completed 107 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2018-12-19
Primary completion
2022-07-27
Completion
2025-04-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Ianalumab Monoclonal antibody 300 mg Subcutaneous
Subject iscalimab Monoclonal antibody 10 mg/kg Intravenous
Subject iscalimab Monoclonal antibody 13 mg/kg Intravenous