A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
Condition(s) studied
Investigational drug(s) / intervention(s)
Cenerimod: Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg.
Placebo: Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.
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.
Eligibility
Primary outcome measure(s)
- Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline — At Month 12 compared to Day 1 (pre-dose baseline)
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 increase ≥ 0.30 points on a 3-point Physician's Global Assessment visual analog scale (PGA VAS), and * No violation of specified medication rules detailed in the core protocol.
Trial sites (198)
| Facility | City | Region | Status |
|---|---|---|---|
| California Research Institute | Huntington Park | California | |
| University of Colorado Denver | Aurora | Colorado | |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | |
| Omega Research MetroWest, LLC | DeBary | Florida | |
| Alloy Clinical Research, LLC | Kissimmee | Florida | |
| SouthCoast Research Center, Inc. | Miami | Florida | |
| Allied Biomedical Research Institute | Miami | Florida | |
| Professional research Center INC | Miami | Florida | |
| IRIS Research and Development, LLC | Plantation | Florida | |
| Augusta University | Augusta | Georgia | |
| Advance Quality Medical Research | Orland Park | Illinois | |
| Accurate Clinical Research Inc. - Lake Charles | Lake Charles | Louisiana | |
| Louisiana State University School of Medicine section of Rheumatology | New Orleans | Louisiana | |
| Axon Clinical Research -Baltimore | Baltimore | Maryland | |
| Bronx Care Health and Wellness Center | The Bronx | New York | |
| DJL Clinical Research, PLLC | Charlotte | North Carolina | |
| University of Oklahoma College of Medicine | Oklahoma City | Oklahoma | |
| Accurate Clinical Research Inc. | Baytown | Texas | |
| Rheumatology Care Center, PLLC | Bellaire | Texas | |
| Houston MD Medspa and Wellness Clinic | Houston | Texas | |
| Accurate Clinical Research Inc. | Houston | Texas | |
| Sun Research Institute | San Antonio | Texas | |
| Fundación Respirar | Buenos Aires | Argentina | |
| Instituto Medico CER | Buenos Aires | Argentina | |
| Aprillus Asistencia e Investigacion | Buenos Aires | Argentina | |
| Arsema Clinica Adventista Belgrano | Buenos Aires | Argentina | |
| IR Medical Center /Hospital de Día/ Instituto de Reumatología y Traumatología | Mendoza | Argentina | |
| Instituto CAICI SRL | Rosario | Argentina | |
| Centro de investigaciones medicas Tucuman | San Miguel de Tucumán | Argentina | |
| Centro Integral de Reumatología | San Miguel de Tucumán | Argentina | |
| ICT (Investigaciones Clínicas Tucumán) | San Miguel de Tucumán | Argentina | |
| Santa Casa de Belo Horizonte | Belo Horizonte | Brazil | |
| Centro Mineiro de Pesquisas | Juiz de Fora | Brazil | |
| Instituto Méderi de Pesquisa e Saúde | Passo Fundo | Brazil | |
| Centro Multidisciplinar de Pesquisa Clínica (Irmandade da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | Brazil | |
| LMK Servicos Medico S/S | Porto Alegre | Brazil | |
| IMPAR SERVICOS HOSPITALARES S/A ; Hospital São Lucas | Rio de Janeiro | Brazil | |
| SER - Serviços Especializados em Reumatologia da Bahia | Salvador | Brazil | |
| Hospital de Clínicas de Porto Alegre | Santa Cecília | Brazil | |
| Centro Multidiciplinar de Estudos Clínicos- CEMEC | São Bernardo do Campo | Brazil |
+ 158 more sites — see the full list on the official registry below.
More Viatris Innovation GmbH trials in Poland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05648500 on ClinicalTrials.gov ↗ ← All trials in Poland