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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)
Phase 2 trial testing cenerimod 4 mg in SLE - Systemic Lupus Erythematosus in 15 participants. Enrolling by invitation.
8 October 2027
Quick facts
| Lead sponsor | Viatris Pharmaceuticals Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 14 January 2026 |
| Primary completion | 8 October 2027 |
| Estimated completion | 8 October 2027 |
| Sites | 7 locations across China |
Drugs / interventions tested
- cenerimod 4 mg — full drug profile →
Conditions studied
- SLE - Systemic Lupus Erythematosus — all drugs for SLE - Systemic Lupus Erythematosus →
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.
Verify or expand the search:
- PubMed search for NCT07266090
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07266090 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Viatris Pharmaceuticals Co., Ltd.
- Last refreshed: 17 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07266090.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing