Clinical Trial

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

Study acronym: OPUS-2
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 39 amendments
This ClinicalTrials.gov record has been amended 39 times since 2023-01-03; most recent amendment 2026-07-13.
Status change: Recruiting → Active, Not Recruiting 2026-02-04
Status change: Not Yet Recruiting → Recruiting 2023-02-17
Trial Details
NCT Number NCT05672576
Lead Sponsor Viatris Innovation GmbH
Conditions Lupus Erythematosus, Systemic
Enrollment 451 participants
Start Date 2023-06-26
Primary Completion 2026-10-31 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-28