Actively Recruiting
Efficacy, Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus and Active Lupus Nephritis in Combination With Background Therapy
Led by Viatris Innovation GmbH · Updated on 2026-05-22
300
Participants Needed
10
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating cenerimod combined with regular treatment to see if it improves kidney function and is safe for adults with systemic lupus erythematosus (SLE) who have active lupus nephritis. The study is a Phase 3 clinical trial comparing cenerimod with a placebo to understand its effects on kidney health and potential medical problems during treatment. Participants will take either cenerimod or a placebo once daily for about 76 weeks (1.5 years) alongside their usual lupus nephritis therapy, which includes medications like mycophenolate mofetil and corticosteroids. The trial is designed as a double-blind, randomized study with two groups: one receiving cenerimod and the other a matching placebo. During the study, participants will visit the clinic every 1 to 3 months for checkups and tests. Researchers will measure kidney response at week 76 and monitor safety throughout the trial. The main outcome is complete renal response, which assesses kidney function improvement. Participants will be closely monitored for side effects and adherence to treatment during the entire study period.
CONDITIONS
Brief 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
- Diagnosis of systemic lupus erythematosus according to 2019 EULAR/ACR criteria
- Renal biopsy within 6 months showing Class III, IV, or pure Class V active lupus nephritis, or willingness to have biopsy during screening
- Active kidney disease with urine protein/creatinine ratio ≥ 1 mg/mg
- Estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m² with specific biopsy criteria if eGFR is between 15 and <30
- Currently on or starting induction therapy with mycophenolate mofetil or mycophenolate sodium
- Receiving corticosteroids as specified (intravenous pulses followed by oral prednisone or oral prednisone alone)
- If on antimalarial or belimumab, treatment must be stable for at least 4 weeks prior to screening and continued
- Willingness to use highly effective contraception and undergo monthly pregnancy testing if of childbearing potential
You will not qualify if you...
- Severe active central nervous system lupus
- Other kidney diseases affecting lupus nephritis assessment or requiring dialysis/transplant
- Certain heart conditions including Mobitz type II or third-degree AV block, sick sinus syndrome, symptomatic bradycardia, or recent serious cardiac events
- Resting heart rate below 50 bpm at screening or randomization
- Active or latent tuberculosis within 6 months prior to screening
- Negative varicella-zoster virus antibody test
- Positive serology for acute or chronic hepatitis A, B, C, or E infections
- Positive HIV test or other immunodeficiency
- Certain eye conditions detected by ophthalmological evaluation
- Significant blood abnormalities (very low hemoglobin, lymphocytes, white blood cells, or platelets)
- Recent treatment with cyclosporine, voclosporin, tacrolimus, sirolimus, or cyclophosphamide
- Recent treatment with leflunomide, intravenous immunoglobulins, methotrexate, or tyrosine kinase inhibitors
- Treatment with anifrolumab within 6 months prior to randomization
- Recent treatment with biological immunosuppressants or B cell-depleting agents within specified timeframes
- Previous participation in any trial involving cenerimod
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 76 weeks
Participants receive daily doses of either cenerimod or matching placebo along with their regular lupus nephritis therapy.
Regular visits throughout the treatment period for monitoring and assessments
Trial Site Locations
Total: 10 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
Texas Arthritis Center
El Paso, Texas, United States, 79902
Actively Recruiting
9
Novel Research, LLC.
Houston, Texas, United States, 77024
Actively Recruiting
10
Northwest Houston Arthritis
Houston, Texas, United States, 77090
Actively Recruiting
Research Team
V
Viatris Innovation Clinical Trial Information
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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