drugset / Trial / NCT06475742

Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus

NCT06475742

Phase 3 Enrolling by invitation 680 enrolled Viatris Innovation GmbH
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus. The main questions it aims to answer are: * Whether cenerimod causes any adverse effects ('side effects') when given on top of drugs already being given for systemic lupus erythematosus. * How well cenerimod works to reduce symptoms of systemic lupus erythematosus when taken for at least 1 year and up to 3 years. Participants taking part in this study will have already taken part in another study, where they received either cenerimod or placebo (look-alike substance containing no active drug) for 1 year. In this clinical study approximately 680 participants will receive cenerimod (on top of drugs already being given for systemic lupus erythematosus) for at least 1 year and up to 3 years.

Timeline

Start
2024-07-30
Primary completion
2028-05
Completion
2028-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cenerimod Small molecule 4 mg Oral