NCT05648500

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms. The main questions it aims to answer are: * How well cenerimod works on top of the treatment already being administered. * How safe cenerimod is for adult patients with Systemic Lupus Erythematosus. Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered. In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	Cenerimod	Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg.
DRUG	Placebo	Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.

Timeline

• Start date: 2022-12-13
• Primary completion: 2026-10-31
• Completion: 2027-05-01
• First posted: 2022-12-13
• Last updated: 2026-04-02

Locations

216 sites across 17 countries: United States, Argentina, Brazil, Bulgaria, Colombia, France, Greece, India, Japan, Mexico, Philippines, Poland, Romania, South Korea, Taiwan, Thailand, Ukraine

Regulatory

• FDA-regulated drug study