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cenerimod 4 mg

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

Ensayo de Viatris Inc en SLE - Systemic Lupus Erythematosus (del registro, en inglés).

Fase

Fase 2

Estado

En marcha, sin reclutar

Participantes

15

previstos

Centros

7

Fin del objetivo primario

oct 2027

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en ene 2026.

Qué mide

Number of participants with treatment-emergent adverse events (AEs) (From first dose of study treatment up to 180 days after the last dose) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

Más ensayos de VTRS

Todos los de VTRS, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07266090), actualizada en jul 2026.