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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)

ENROLLING BY INVITATION Phase 2 Last updated 17 April 2026
What this trial tests

Phase 2 trial testing cenerimod 4 mg in SLE - Systemic Lupus Erythematosus in 15 participants. Enrolling by invitation.

Timeline
14 January 2026
Primary endpoint
8 October 2027
8 October 2027

Quick facts

Lead sponsorViatris Pharmaceuticals Co., Ltd.
PhasePhase 2
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment15
Start date14 January 2026
Primary completion8 October 2027
Estimated completion8 October 2027
Sites7 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Viatris Pharmaceuticals Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with SLE - Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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