drugset / Trial / NCT05672576

A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus

NCT05672576

Phase 3 Active not recruiting 451 enrolled Viatris Innovation GmbH
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous 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.

Timeline

Start
2023-06-26
Primary completion
2026-10-31
Completion
2027-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cenerimod Small molecule 4 mg Oral