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A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
NCT05648500 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms. The main questions it aims to answer are: * How well cenerimod works on top of the treatment already being administered. * How safe cenerimod is for adult patients with Systemic Lupus Erythematosus. Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered. In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cenerimod
Study Locations (20)
Florida
- RASF-Clinical Research Inc. — Boca Raton
- Clinical Research of West Florida, Inc. — Clearwater
- Omega Research MetroWest, LLC — DeBary
- Alloy Clinical Research, LLC — Kissimmee
- SouthCoast Research Center, Inc. — Miami
- Allied Biomedical Research Institute — Miami
- Professional research Center INC — Miami
- IRIS Research and Development, LLC — Plantation
- Renew Health Clinical Research LLC — Tampa
California
- Providence Medical Foundation — Fullerton
- California Research Institute — Huntington Park
Louisiana
- Accurate Clinical Research Inc. - Lake Charles — Lake Charles
- Louisiana State University School of Medicine section of Rheumatology — New Orleans
Maryland
- Axon Clinical Research -Baltimore — Baltimore
- Klein & Associates, M.D., P.A. — Hagerstown
Colorado
- University of Colorado Denver — Aurora
Georgia
- Augusta University — Augusta
Illinois
- Advance Quality Medical Research — Orland Park
Michigan
- June DO, PC — Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2022-12-13 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05648500
The ClinicalTrials.gov registry entry for NCT05648500 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Viatris Innovation, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05648500 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05648500 about?
NCT05648500 is a clinical study titled "A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus". The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms. The main questions it aims to answer are: * How well cenerimod works on top of the treatment already being administered. * How safe cener...
What is the current status of trial NCT05648500?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2022-12-13. Estimated completion is 2027-05-01.
What conditions does trial NCT05648500 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05648500?
The interventions under investigation include: Placebo (DRUG), Cenerimod (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05648500?
This trial is sponsored by Viatris Innovation, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05648500 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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