Clinical Trial

A Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE)

Active, Not Recruiting Phase 2
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Summary
The goal of this clinical trial is to learn about the safety, how the body processes the drug, and its effects of a drug called cenerimod in adult Chinese participants (aged 18-75) with moderate to severe Systemic Lupus Erythematosus (SLE) who are already receiving standard background therapy. The main questions it aims to answer are: * What is the safety and tolerability of a daily 4 mg dose of cenerimod in Chinese participants with SLE? * How is cenerimod processed by the body (pharmacokinetics) in this population? * What is the effect of cenerimod on the level of lymphocytes in the blood (pharmacodynamics)? This is a single-arm study without a comparison group. Participants will: * Take one 4 mg cenerimod tablet by mouth once daily for up to 12 months. * Continue their stable, pre-existing background SLE medications throughout the study. * Attend regular clinic visits over a period of up to 22 months for tests and check-ups, including blood draws, heart monitoring (12-lead electrocardiogram), vital signs(blood pressure),and physical examinations. * Undergo a final safety follow-up 6 months after their last dose of the study drug.
Protocol Amendment History 1 change
critical Trial status changed: Enrolling by Invitation → Active, Not Recruiting 2026-05-21
Trial Details
NCT Number NCT07266090
Lead Sponsor Viatris Pharmaceuticals Co., Ltd.
Conditions SLE - Systemic Lupus Erythematosus
Enrollment 15 participants
Start Date 2026-01-14
Primary Completion 2027-10-08 (estimated)
Study Completion 2027-10-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-28