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NCT05648500 · ClinicalTrials.gov registry record · Phase 3
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
A Phase 3 study of Lupus Erythematosus, Systemic, sponsored by Viatris Innovation.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
- 20
- Study locations
NCT05648500 is a Phase 3 study of Lupus Erythematosus, Systemic that is actively recruiting participants, run by Viatris Innovation. The registered enrollment target is 420 participants, above the 189-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (122% higher). The trial reports 20 study locations across 9 states.
The verdict
NCT05648500, a Phase 3 study of Lupus Erythematosus, Systemic, is actively recruiting participants, sponsored by Viatris Innovation.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 189-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (122% higher). The listed sponsor is Viatris Innovation, which has 11 total studies on file at ClinicalTrials.gov.
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.
NCT05648500 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Louisiana.
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.
What interventions are being tested in trial NCT05648500?
The interventions under investigation include: Placebo (DRUG), Cenerimod (DRUG).
Who is sponsoring clinical trial NCT05648500?
This trial is sponsored by Viatris Innovation, which has 11 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
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