NCT02472795

Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.

Detailed description

This multicentre, double-blind, placebo-controlled study will have a staggered approach (Part A and B). In part A, eligible patients will be randomly assigned (1:1:1:1) to once daily oral administration of cenerimod (0.5, 1, 2 mg) or placebo. After all patients have completed 4 weeks of treatment during part A, an Independent Data Monitoring Committee will review non-blinded data in an interim analysis to evaluate the safety profile of cenerimod and recommend whether the study could proceed to part B. In part B, additional patients will be randomized (3:1) to once daily oral administration of cenerimod 4 mg or placebo. All participants will receive study medication for 12 weeks.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Matching placebo	One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).
DRUG	Cenerimod	One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-01-23
• Completion: 2017-02-28
• First posted: 2015-06-16
• Last updated: 2025-10-03
• Results posted: 2020-02-26

Locations

18 sites across 6 countries: United States, Belarus, Bulgaria, Georgia, Russia, Ukraine