At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE)
In Brief
A Phase 2 clinical trial evaluating VAY736, VAY736 Placebo, and 2 other interventions for Systemic Lupus Erythematosus (SLE). Completed, enrolled 107 participants across 31 sites in 15 countries.
Detailed 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
Study Details
Timeline
Interventions
150 mg powder in vial for solution for injection; after reconstitution to 150 mg/mL per vial, a dose of 300 mg
solution for injection; 0 mg/mL administered as 2 mL s.c. injection
150 mg/mL as concentrate in vial for infusion, administered at a dose of 10 mg/kg as i.v. infusion
Placebo as concentrate in vial for infusion, administered at a dose of 10 mg/kg as i.v. infusion