NCT07266090

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

A Multicenter,Open-label,Single Arm,Multiple-dose Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Viatris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SLE - Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	cenerimod 4 mg	cenerimod 4 mg once daily for 12 months

Timeline

• Start date: 2026-01-14
• Primary completion: 2027-10-08
• Completion: 2027-10-08
• First posted: 2025-12-05
• Last updated: 2026-04-17

Locations

7 sites across 1 country: China