A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of Cenerimod in Adult Patients With Systemic Lupus Erythematosus and Active Lupus Nephritis in Combination With Background Therapy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 76 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether cenerimod added to regular treatment helps the kidneys and is safe for adults with lupus and active lupus nephritis (kidney swelling caused by lupus). Participants take cenerimod or a placebo (a look-alike pill with no drug) daily for 76 weeks. They visit the clinic every 1 to 3 months for checkups and tests.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have systemic lupus erythematosus (SLE) diagnosed using the study’s required rules.
- Have a kidney biopsy (a small tissue sample) showing active class III or IV lupus nephritis, with or without class V, or class V alone. The biopsy must be recent or done during screening.
- Have a protein-to-creatinine ratio of at least 1 mg/mg in urine collected over 24 hours. This measures protein leaking into the urine.
- Have an eGFR (a measure of how well the kidneys filter blood) of at least 15. People with a result below 30 must meet extra biopsy rules about kidney damage and active disease.
- Start or already take the required mycophenolate medicine, and receive steroids at the study’s required doses.
- If taking an antimalarial medicine or belimumab, have started it at least 4 weeks before screening and keep the dose steady as required. If taking azathioprine, switch to mycophenolate before treatment assignment.
- If able to become pregnant, use highly effective birth control and take monthly pregnancy tests during the study and for at least 24 weeks after stopping the study medicine.
Who can't join
- Severe active lupus affecting the brain or spinal cord; another kidney disease that could affect study results; or kidney disease requiring dialysis or a transplant, or end-stage kidney disease.
- Certain heart rhythm problems, fainting linked to heart disease, or a resting heart rate below 50 beats per minute. Certain serious heart problems, stroke, mini-stroke, or blood clots within the past 6 months also exclude people.
- Active or inactive tuberculosis now or within the past 6 months; a negative chickenpox virus antibody test; tests showing hepatitis A, B, C, or E infection; HIV; or another condition that weakens the immune system.
- Certain eye problems found during screening, including swelling, damage, inflammation, or abnormal blood vessel growth in the back of the eye.
- Very low levels of hemoglobin (the part of blood that carries oxygen), white blood cells, or platelets (cells that help blood clot).
- Recent use of certain medicines that lower immune activity, including cyclosporine, voclosporin, tacrolimus, sirolimus, cyclophosphamide, leflunomide, methotrexate, IV immunoglobulins, tyrosine kinase inhibitors, or certain biologic medicines. Required waiting times depend on the medicine.
- Any past use of alemtuzumab or medicines called sphingosine-1-phosphate receptor modulators, such as fingolimod; or past assignment to cenerimod or placebo in a cenerimod trial.
- Pregnant, planning to become pregnant, or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Main Inclusion Criteria: * Classification of systemic lupus erythematosus (SLE) made according to the 2019 European Alliance of Associations for Rheumatology / American College of Rheumatology (EULAR/ACR) criteria. * Renal biopsy within 6 months prior to Screening visit indicating Class III or IV active glomerulonephritis with or without co-existing Class V, OR pure Class V membranous LN. If no biopsy was performed within 6 months of Screening, a biopsy will be performed during the Screening period, after all other inclusion/exclusion criteria are verified. * 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: 1. Mycophenolate mofetil 1-3 g/day orally or mycophenolate sodium 720-2160 mg/day orally at Randomization. This treatment can be in place before Screening or started at Screening. 2. Corticosteroids: 1-3 intravenous (i.v.) pulses of methylprednisolone at 250 to 1000 mg/pulse/day (maximum cumulative 3000 mg) followed by oral prednisone (or equivalent) at 0.5 mg/kg/day with a cap at 40 mg/day. Pulses can be administered during screening and up to 2 weeks prior to screening. Participants who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/kg/day (max 80 mg/day) oral prednisone (or equivalent), within the same window as i.v. pulses. Note: If treatment with an antimalarial or belimumab is taken, it must be initiated at least 4 weeks prior to Screening and must be at stable dose during these 28 days prior to Randomization and continued at a stable dose until End-of-Treatment. Participants on azathioprine must be switched to mycophenolate mofetil or mycophenolate sodium prior to Randomization. * 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. Main Exclusion Criteria: * 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.
Study sites (14)
FL
- Dolphin Medical Research · Doral, FL 33172More trials in Doral
- Alloy Clinical Research LLC · Kissimmee, FL 34741More trials in Kissimmee
- SouthCoast Research Center · Miami, FL 33136More trials in Miami
- Allied Biomedical Research Institute · Miami, FL 33155More trials in Miami
- DH NationalResearchCenters INC · Miami, FL 33155More trials in Miami
- ProfessionalResearchCenter INC · Miami, FL 33172More trials in Miami
- San Marcus Research Clinic, Inc. · Miami Lakes, FL 33014More trials in Miami Lakes
MI
- Revive Research Institute, LLC · Sterling Heights, MI 48313More trials in Sterling Heights
TX
- Rheumatology Care Center, PLLC · Bellaire, TX 77401More trials in Bellaire
- Texas Arthritis Center · El Paso, TX 79902More trials in El Paso
- Novel Research, LLC. · Houston, TX 77024More trials in Houston
- Northwest Houston Arthritis · Houston, TX 77090More trials in Houston
- Discovery Clinical Trials LLC · San Antonio, TX 78229More trials in San Antonio
- Azul Bioresearch Llc · Sugarland, TX 77479More trials in Sugarland