Clinical Trial

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

Study acronym: OPUS-1
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 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.
Protocol Amendment History 3 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-01
notable Enrollment increased: 420 -> 470 participants 2026-05-01
notable Trial sites reduced: 216 -> 198 locations 2026-05-01
Trial Details
NCT Number NCT05648500
Lead Sponsor Viatris Innovation GmbH
Conditions Lupus Erythematosus, Systemic
Enrollment 470 participants
Start Date 2022-12-13
Primary Completion 2026-10-31 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-28