NCT03656562

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study consists of a 28-day screening period, a blinded treatment period of 28 weeks where randomized patients received treatment with investigational drug (ianalumab or iscalimab) or placebo. At the end of Week 29 visit, the patients enter the open label treatment phase where patients in active treatment group continued to receive active treatment and patients in placebo group started active treatment with ianalumab/iscalimab until Week 49. After completion of the open-label treatment period, all patients enter a Follow-Up period in order to monitor safety and efficacy up to Week 69. The Week 69 visit is the End of Study (EoS) visit for patients in Cohort 2 (CFZ533). Study duration for patients in Cohort 2 will be approximately 18 months. For Cohort 1 (VAY736). Patients who do not achieve B-cell recovery by Week 69 Visit will enter into a Secondary Follow-Up period until achieving B cell recovery criteria (B-cell count is at \>= 50 cells/µl or at least 80% of baseline levels). Safety follow-up visits will be scheduled as deemed appropriate until the patient achieves the B cell recovery criteria, followed by an EoS 4 weeks later.

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
DRUG	VAY736	150 mg powder in vial for solution for injection; after reconstitution to 150 mg/mL per vial, a dose of 300 mg
DRUG	VAY736 Placebo	solution for injection; 0 mg/mL administered as 2 mL s.c. injection
DRUG	CFZ533	150 mg/mL as concentrate in vial for infusion, administered at a dose of 10 mg/kg as i.v. infusion
DRUG	CFZ533 Placebo	Placebo as concentrate in vial for infusion, administered at a dose of 10 mg/kg as i.v. infusion

Timeline

• Start date: 2018-12-19
• Primary completion: 2022-07-27
• Completion: 2025-04-28
• First posted: 2018-09-04
• Last updated: 2025-10-07
• Results posted: 2024-06-06

Locations

31 sites across 15 countries: Argentina, Australia, China, Czechia, France, Germany, Hungary, Israel, Japan, Poland, Russia, South Korea, Spain, Taiwan, Thailand

Regulatory

• FDA-regulated drug study