Clinical Trial

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

Study acronym: OPUS OLE
Enrolling by Invitation Phase 3
View on ClinicalTrials.gov →
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 up to 5 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 up to 5 years.
Protocol Amendment History 2 changes
notable Trial sites expanded: 106 -> 122 locations 2026-07-29
notable Trial sites expanded: 92 -> 106 locations 2026-05-07
Trial Details
NCT Number NCT06475742
Lead Sponsor Viatris Innovation GmbH
Conditions Lupus Erythematosus, Systemic
Enrollment 680 participants
Start Date 2024-07-30
Primary Completion 2028-05 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-28