A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus (NCT05648500)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy
π©Ί Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: California Research Institute β Huntington Park, California
Age range: 18 Years to 75 Years
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (198 Sites)
Showing the first 25 of 198 sites.
- California Research Institute β Huntington Park, California
- University of Colorado Denver β Aurora, Colorado
- Clinical Research of West Florida, Inc. β Clearwater, Florida
- Omega Research MetroWest, LLC β DeBary, Florida
- Alloy Clinical Research, LLC β Kissimmee, Florida
- SouthCoast Research Center, Inc. β Miami, Florida
- Allied Biomedical Research Institute β Miami, Florida
- Professional research Center INC β Miami, Florida
- IRIS Research and Development, LLC β Plantation, Florida
- Augusta University β Augusta, Georgia
- Advance Quality Medical Research β Orland Park, Illinois
- Accurate Clinical Research Inc. - Lake Charles β Lake Charles, Louisiana
- Louisiana State University School of Medicine section of Rheumatology β New Orleans, Louisiana
- Axon Clinical Research -Baltimore β Baltimore, Maryland
- Bronx Care Health and Wellness Center β The Bronx, New York
- DJL Clinical Research, PLLC β Charlotte, North Carolina
- University of Oklahoma College of Medicine β Oklahoma City, Oklahoma
- Accurate Clinical Research Inc. β Baytown, Texas
- Rheumatology Care Center, PLLC β Bellaire, Texas
- Houston MD Medspa and Wellness Clinic β Houston, Texas
- Accurate Clinical Research Inc. β Houston, Texas
- Sun Research Institute β San Antonio, Texas
- FundaciΓ³n Respirar β Buenos Aires,
- Instituto Medico CER β Buenos Aires,
- Aprillus Asistencia e Investigacion β Buenos Aires,
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Lupus Erythematosus, Systemic
- A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE) β Phoenix, Arizona
- Interactive Digital Technology to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus β Denver, Colorado
- 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 β Homewood, Alabama
- Engagement in CHildhood-Onset Systemic Lupus β The Bronx, New York
- A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus β Tucson, Arizona
Explore by condition: All Lupus Erythematosus, Systemic clinical trials
π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.