Research Trial for Cenerimod in Lupus Nephritis
This research trial is studying if cenerimod, when added to your regular treatment, can effectively and safely treat active lupus nephritis (kidney inflammation caused by lupus) in adults. You may be eligible if you are between 18 and 75 years old, have systemic lupus erythematosus (SLE) diagnosed by specific criteria, and have active lupus nephritis confirmed by a recent kidney biopsy. The main goal is to see if cenerimod improves kidney function. Researchers will compare cenerimod to a placebo (an inactive pill) over 76 weeks (about 1.5 years). The trial is currently unclear on its recruitment status and plans to enroll 300 participants.
- Study design
- This is an interventional study comparing cenerimod to a placebo in 300 planned participants.
- What's involved
- You would take cenerimod or a placebo daily for about 1.5 years, in addition to your regular treatment. You would also have clinic visits every 1 to 3 months for checkups and tests.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, complete renal response, is measured at Week 76.
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NCT07201129
A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
Recruiting
PHASE3Ages 18–75InterventionalTreatmentViatris Innovation GmbH
~300 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:CenerimodPlacebo
At a glance
Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete renal response (CRR)
Measured over At Week 76
Conditions
Where it's being run
14 sites across 3 statesFlorida7
Texas6
Michigan1
Study leadership
- Clinical Trials · STUDY_DIRECTOR · Viatris Innovation GmbH
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Classification of systemic lupus erythematosus (SLE) made according to the 2019 European Alliance of Associations for Rheumatology / American College of Rheumatology (EULAR/ACR) criteria.
Active renal disease defined as urine protein/creatinine ratio ≥ 1 mg/mg, assessed on a 24h urine collection.
eGFR ≥ 15 mL/min/1.73 m\^2. Enrollment of participants with eGFR between ≥ 15 and \< 30 mL/min/1.73 m\^2 requires:
a renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli,
activity index ≥ 2, and chronicity index \< 4, on the National Institutes for Health 2018 activity and chronicity indices. These indices must be assessed on the kidney biopsy dated less than 6 months prior to Screening and confirmed by a nephropathologist.
Initiation of the induction therapy with the mandatory following background therapy:
Participants of childbearing potential must agree to:
Use a highly effective method of contraception from the Screening visit up to at least 24 weeks after discontinuation of trial intervention.
Undertake monthly urine pregnancy tests during the trial and up to at least 24 weeks after discontinuation of trial intervention.
Exclusion
Severe active central nervous system lupus
History of, or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with the LN assessment and confound the disease activity assessment (e.g., diabetic nephropathy), or require dialysis, transplantation or end-stage renal disease.
History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia, or syncope associated with cardiac disorders.
Participants who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by the New York Heart Association Class III/IV within 6 months prior to Screening.
Resting heart rate \< 50 bpm as measured by the 12-lead electrocardiogram (ECG) at Screening or at Randomization.
Diagnosis of active or latent tuberculosis at Screening or within 6 months prior to Screening
Negative antibody test for varicella-zoster virus
Positive results for serological markers for hepatitis A, B, C and E indicating acute or chronic infection
Participants with a positive human immunodeficiency virus (HIV) test or who have any other congenital or acquired immunodeficiency
Presence of any of the following abnormalities, detected during the ophthalmological evaluation and/or by optical coherence tomography, as evaluated by the site ophthalmologist, during Screening:
Macular edema of any cause: diabetic, cystoid, tractional.
Foveal degeneration: macular hole, macular pseudohole, hereditary or degenerative maculopathies.
Active uveitis, papilledema.
Retinal neovascularization of any cause and in any location.
Significant hematology abnormality at Screening:
Hemoglobin \< 7 g/dL;
Lymphocyte count \< 500 /μL (0.5 × 10\^9/L);
White blood cell count \< 1500/μL (1.5 × 10\^9/L) or
Platelets \< 25,000/μL (25 × 10\^9/L)
Treatment with the following medications within 5 half-lives of the medication prior to Randomization: Cyclosporine, voclosporin, tacrolimus, sirolimus, cyclophosphamide.
Treatment with the following medications within 90 days prior to Randomization:
Leflunomide.
i.v. immunoglobulins.
Methotrexate.
Tyrosine kinase inhibitors.
Treatment with anifrolumab within 6 months prior to Randomization.
Treatment with biological immunosuppressive agents, (e.g., anti-tumor necrosis factor \[anti-TNF\], anti-interleukin-1 \[anti-IL1\], anti-IL6 therapies) within 90 days prior to Randomization.
Treatment with B cell-depleting biological agents (e.g., rituximab, obinutuzumab or ocrelizumab) within 12 months prior to Randomization.
Treatment with any of the following medications any time prior to Screening:
Alemtuzumab.
Sphingosine-1-phosphate receptor modulators (e.g., fingolimod).
Participants previously randomized to cenerimod or placebo in any trial involving cenerimod.
Pregnancy confirmed via a serum pregnancy test at the Screening visit or a urine/serum pregnancy test at the Randomization visit or planning to become pregnant, or lactating participant.
What this trial measures
- Complete renal response (CRR)At Week 76
CRR at Week 76, defined as (both must be met): * Urine protein to creatinine ratio (UPCR) ≤ 0.5 mg/mg AND * No decrease from baseline of ≥ 20% in estimated glomerular filtration rate (eGFR)