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NCT05672576 · ClinicalTrials.gov registry record · Phase 3
A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
A Phase 3 study of Lupus Erythematosus, Systemic, sponsored by Viatris Innovation.
- Active
- Registry status
- Phase 3
- Development phase
- 451
- Enrollment target
- 20
- Study locations
NCT05672576: Active Phase 3 study of Lupus Erythematosus, Systemic, sponsored by Viatris Innovation.
NCT05672576 is a Phase 3 study of Lupus Erythematosus, Systemic that is active but no longer recruiting, run by Viatris Innovation. The registered enrollment target is 451 participants, above the 188-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (140% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05672576, a Phase 3 study of Lupus Erythematosus, Systemic, is active but no longer recruiting, sponsored by Viatris Innovation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 451 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 Erythematous 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.
Primary Outcome
Response on SRI-4 is defined as: * Reduction from baseline of at least 4 points in the modified Systemic Lupus Erythematosus Disease Activity Index-2000 score (mSLEDAI-2K \[SLEDAI-2K modified to exclude leukopenia, thus mSLEDAI-2K\]), and * No new British Isles Lupus Assessment Group-2004 (BILAG) A organ domain score and not more than one new BILAG B organ domain score compared to baseline, and * No worsening from baseline in subjects' lupus disease activity, where worsening is defined as an in
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cenerimod
Study Locations (20)
Florida
- Hope Clinical Trials, Inc. - Coral Gables
- Vital Pharma Research - Hialeah
- Tectum Medical Research - Hollywood
- Alloy Clinical Research, LLC - Kissimmee
- Allied Biomedical Research Institute - Miami
- D&H National Research Centers INC - Miami
- Professional research Center INC - Miami
- San Marcus Research Clinic, Inc. - Miami Lakes
California
- UCSD Perlman Medical Offices - La Jolla
- Amicis Research Center - Northridge
- BioSolutions Clinical Research Center - Poway
Texas
- Precision Comprehensive Clinical Research Solutions - Colleyville
- Texas Arthritis Center - El Paso
- Northwest Houston Arthritis Center - Houston
Other
- Biomedica Research Group - Providencia
- Sociedad Médica del Aparato Locomotor S. A. - Providencia
Arizona
- Tucson Clinical Research Institute, LLC - Tucson
Louisiana
- Tandem Clinical Research - Marrero
Nevada
- RB Wellness Clinic - Las Vegas
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 451 participants |
| Start Date | 2023-06-26 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 3 |
What the registry record for NCT05672576 still lists
NCT05672576 is an interventional study that assigns participants to a tested intervention. The registered 451 participants enrollment target is mid-sized for trials with a published cap, above the 188-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (140% higher).
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.
NCT05672576 names 20 study sites across 8 states, led by Florida, California, Texas.
Frequently Asked Questions
What is clinical trial NCT05672576 about?
NCT05672576 is a clinical study titled "A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus". The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous 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 ceneri...
What is the current status of trial NCT05672576?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 451 participants. The study started on 2023-06-26. Estimated completion is 2027-05-01.
What conditions does trial NCT05672576 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic.
What interventions are being tested in trial NCT05672576?
The interventions under investigation include: Placebo (DRUG), Cenerimod (DRUG).
Who is sponsoring clinical trial NCT05672576?
This trial is sponsored by Viatris Innovation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05672576 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Louisiana, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05672576's enrollment target sits among peer trials
451 4th of 29 higher than 26 of 29 other Lupus Erythematosus, Systemic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Erythematosus, Systemic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
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