Actively Recruiting
A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
Led by Viatris Innovation GmbH · Updated on 2026-04-28
300
Participants Needed
9
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis. It will also learn about the safety of cenerimod. The main questions it aims to answer are: * Does cenerimod improve kidney function in participants? * What medical problems do participants have when taking cenerimod? Researchers will compare cenerimod to a placebo (a look-alike substance that contains no drug) to see how well cenerimod works when it is added to regular treatment. Participants will: * Take cenerimod or a placebo every day for 76 weeks (approximately 1.5 years), on top of regular treatment. * Visit the clinic every 1 to 3 months for checkups and tests.
CONDITIONS
Official Title
A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with systemic lupus erythematosus according to 2019 EULAR/ACR criteria
- Kidney biopsy within 6 months showing Class III, IV, or pure Class V lupus nephritis, or biopsy performed during screening
- Active renal disease with urine protein/creatinine ratio ≥ 1 mg/mg
- Estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m²
- For eGFR between 15 and <30, biopsy must show ≤ 50% glomeruli sclerosis, activity index ≥ 2, and chronicity index < 4
- Starting or already on induction therapy including mycophenolate mofetil 1-3 g/day (or mycophenolate sodium 720-2160 mg/day)
- Corticosteroids given as 1-3 intravenous pulses followed by oral prednisone 0.5 mg/kg/day (max 40 mg/day), or direct oral prednisone 0.8-1.0 mg/kg/day (max 80 mg/day)
- If on antimalarial or belimumab, treatment must be stable for at least 4 weeks before screening and continue stable during study
- Participants of childbearing potential must agree to highly effective contraception and monthly pregnancy tests during and 24 weeks after treatment
You will not qualify if you...
- Severe active central nervous system lupus
- Other kidney diseases affecting lupus nephritis assessment or requiring dialysis or transplant
- History or current serious heart rhythm problems including Mobitz II or third-degree AV block, sick sinus syndrome, symptomatic bradycardia, or syncope
- Recent (within 6 months) serious heart events like heart attack, unstable angina, stroke, or heart failure requiring hospitalization
- Resting heart rate below 50 bpm at screening or randomization
- Active or latent tuberculosis at screening or within 6 months prior
- Negative varicella-zoster virus antibody test
- Positive hepatitis A, B, C, or E infection markers
- Positive HIV test or other immunodeficiency
- Eye problems such as macular edema, foveal degeneration, active uveitis, papilledema, or retinal neovascularization
- Significant blood abnormalities including very low hemoglobin, lymphocytes, white blood cells, or platelets
- Recent use of certain immunosuppressive or biologic treatments within specified timeframes
- Previous participation in cenerimod trials
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Alloy Clinical Research LLC
Kissimmee, Florida, United States, 34741
Actively Recruiting
2
SouthCoast Research Center
Miami, Florida, United States, 33136
Actively Recruiting
3
Allied Biomedical Research Institute
Miami, Florida, United States, 33155
Actively Recruiting
4
DH NationalResearchCenters INC
Miami, Florida, United States, 33155
Actively Recruiting
5
ProfessionalResearchCenter INC
Miami, Florida, United States, 33172
Actively Recruiting
6
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States, 33014
Actively Recruiting
7
Rheumatology Care Center, PLLC
Bellaire, Texas, United States, 77401
Actively Recruiting
8
Novel Research, LLC.
Houston, Texas, United States, 77024
Actively Recruiting
9
Northwest Houston Arthritis
Houston, Texas, United States, 77090
Actively Recruiting
Research Team
V
Viatris Innovation Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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