Phase 3 Trial of Cenerimod for Lupus Nephritis: Efficacy and Safety Evaluation
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Key Takeaway
Monitor for updates on cenerimod's efficacy in lupus nephritis treatment.
This Phase 3 clinical trial aims to evaluate the efficacy and safety of cenerimod in treating active lupus nephritis in adults with systemic lupus erythematosus. The study involves 300 participants who will receive either cenerimod or a placebo daily for 76 weeks, in addition to their regular treatment. The primary endpoint is the achievement of complete renal response (CRR), which will be assessed over the course of the study. Secondary endpoints include improvements in kidney function and the incidence of adverse events. Participants will attend clinic visits every 1 to 3 months for monitoring and assessments. The trial is sponsored by Viatris Innovation GmbH and is expected to complete primary data collection by August 2029. Safety evaluations will focus on the incidence and severity of adverse events associated with cenerimod. The results of this trial will provide valuable insights into the potential role of cenerimod as an adjunctive therapy for lupus nephritis.
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View Original Abstract ↓
Status: RECRUITING | Phase: PHASE3
Condition(s): Nephritis, Lupus, Lupus Erythematosus, Systemic
Intervention(s): Cenerimod (DRUG), Placebo (DRUG)
The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis. It will also learn about the safety of cenerimod. The main questions it aims to answer are:
* Does cenerimod improve kidney function in participants?
* What medical problems do participants have when taking cenerimod?
Researchers will compare cenerimod to a placebo (a look-alike substance that contains no drug) to see how well cenerimod works when it is added to regular treatment.
Participants will:
* Take cenerimod or a placebo every day for 76 weeks (approximately 1.5 years), on top of regular treatment.
* Visit the clinic every 1 to 3 months for checkups and tests.
Primary Outcome(s): Complete renal response (CRR)
Enrollment: 300 (ESTIMATED)
Lead Sponsor: Viatris Innovation GmbH
Start: 2026-02-09 | Primary Completion: 2029-08
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