Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Lupus Erythematosus, Systemic, sponsored by Viatris Innovation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
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
- 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 |
What NCT05648500 shows while recruiting
NCT05648500 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 189-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (122% 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.
NCT05648500 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
Similar trials for Lupus Erythematosus, Systemic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05648500's enrollment target sits among peer trials
420 5th of 29 higher than 25 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
-
A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
RECRUITING · Phase 3
-
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
RECRUITING · Phase 3
-
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
ACTIVE NOT RECRUITING · Phase 3
-
A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
ACTIVE NOT RECRUITING · Phase 3
-
Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01790152 · 420 participants
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
- NCT02701244 · 420 participants
A Registry Study of Breast Microseed Treatment
- NCT02966665 · 420 participants · Phase 1
: Vascular Function in Health and Disease
- NCT04149743 · 420 participants · NA
HEMOTAG® Assessment for Short-term Outcomes of Heart Failure
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI