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Randomized Placebo‑Controlled Trial of Cenerimod for Efficacy and Safety in Adults with Systemic Lupus Erythematosus and Active Lupus Nephritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Systemic Lupus Erythematosus is an autoimmune condition in which the body’s immune system mistakenly attacks healthy tissues. When this activity involves the kidneys, it is called lupus nephritis and can cause swelling, high blood pressure, and loss of kidney function. The study examines a new oral medication, cenerimod, taken once daily, compared with a matching placebo, alongside the patients’ regular lupus treatments.

The purpose of the study is to determine whether adding cenerimod improves kidney outcomes in adults with active lupus nephritis.

Participants will receive either the cenerimod tablet or the placebo for an extended period while continuing their usual medicines. Throughout the study, they will attend regular visits where urine samples are checked for protein‑to‑creatinine ratio (a simple test that shows how much protein is leaking into the urine) and blood tests are done to estimate the glomerular filtration rate (a measure of how well the kidneys are filtering waste). These checks help determine if the kidneys are responding well to the treatment, and any side effects are also recorded.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and start of study medication

    After joining the trial you will be assigned, by a computer system, to receive either cenerimod or a matching placebo. the assignment is double‑blind, so neither you nor the study staff will know which product you receive.

    The first dose of the study medication will be taken on the day of randomization.

  2. Step 2

    Daily oral intake of study medication

    You will swallow one film‑coated tablet by mouth each day.

    The tablet contains 4 mg of cenerimod if you are in the active arm, or no active drug if you are in the placebo arm.

    The medication is taken once daily for the entire study period, up to week 76.

  3. Step 3

    Continuation of background therapy

    You will continue to receive your regular treatment for systemic lupus erythematosus and active lupus nephritis, which may include corticosteroids such as prednisone.

    The dose of prednisone may be reduced to 5 mg per day or less starting at week 24, if your physician decides this is appropriate.

  4. Step 4

    Regular clinic visits and safety monitoring

    You will attend scheduled clinic visits throughout the trial. during each visit the study team will check for side effects, measure blood pressure, and collect blood and urine samples.

    The urine sample is used to calculate the urine protein‑to‑creatinine ratio, and the blood sample is used to estimate kidney function (eGFR).

    The timing of these visits follows the study schedule, which extends to week 76.

  5. Step 5

    Assessment of kidney response

    At week 76 a final evaluation will be performed to determine whether a complete renal response has been achieved.

    A complete renal response means both of the following conditions are met: urine protein‑to‑creatinine ratio is 0.5 mg/mg or lower, and the estimated glomerular filtration rate has not decreased by 20 % or more from the start of the study.

  6. Step 6

    Study completion

    After the final assessment at week 76 you will finish participation in the trial.

    Any further care will be managed by your regular health‑care provider.

Who can join the trial?

10 criteria

  • You must have a diagnosis of systemic lupus erythematosus (SLE) that meets the 2019 EULAR/ACR classification criteria (a standard set of rules doctors use to confirm lupus).
  • You need a recent kidney biopsy (a small sample of kidney tissue taken with a needle) performed within the last 6 months that shows either Class III or Class IV active glomerulonephritis (inflammation of the kidney’s filtering units) with or without Class V, or a pure Class V membranous lupus nephritis. If you have not had a biopsy in the past 6 months, one will be done during the screening process.
  • Your kidney disease must be active, shown by a urine protein/creatinine ratio of 1 mg/mg or higher on a 24‑hour urine collection (a test that measures how much protein is leaking into the urine over a full day).
  • Your kidney function measured by estimated glomerular filtration rate (eGFR) must be at least 15 mL/min/1.73 m². If your eGFR is between 15 and less than 30, the kidney biopsy must also show no more than 50 % of the filtering units scarred (sclerosis), an activity index of 2 or higher, and a chronicity index below 4 (numbers doctors use to describe how active and how chronic the kidney damage is).
  • You must be starting or already receiving the required background medicines:
    • Mycophenolate mofetil (1‑3 g per day) or mycophenolate sodium (720‑2160 mg per day), which are drugs that suppress the immune system.
    • Corticosteroids, either intravenous methylprednisolone pulses (250‑1000 mg per dose, up to a total of 3000 mg) followed by oral prednisone (or similar) at 0.5 mg per kg of body weight per day (maximum 40 mg per day), or, if you cannot receive the IV pulses, oral prednisone at 0.8‑1.0 mg per kg per day (maximum 80 mg per day).
    • If you are taking an antimalarial medication (such as hydroxychloroquine) or the biologic drug belimumab, you must have been on a stable dose for at least 4 weeks before screening and continue that stable dose throughout the study.
    • If you are currently using azathioprine, you must switch to mycophenolate before randomization.
    • If you are able to become pregnant, you must agree to use a highly effective form of contraception from the time of screening until at least 24 weeks after you stop the study medication, and you must provide a monthly urine pregnancy test during the study and for 24 weeks after stopping.
    • Both men and women can enroll, and the study includes children as well as adults (no specific age limit is listed).

Who cannot join the trial?

21 criteria

  • Having severe and active central nervous system lupus, which means serious inflammation of the brain and spinal cord caused by lupus.
  • Having any eye problems found during an eye exam, such as swelling in the central part of the retina (macular edema), holes or degeneration in the central retina (foveal degeneration), ongoing inflammation inside the eye (active uveitis), swelling of the optic nerve head (papilledema), or new abnormal blood vessels in the retina (retinal neovascularization).
  • Having significant blood‑test abnormalities, including:
    • Hemoglobin less than 7 g/dL (very low red‑blood‑cell level).
    • Lymphocyte count less than 500 cells/µL (very low white‑blood‑cell count).
    • White‑blood‑cell count less than 1,500 cells/µL (low overall white‑blood‑cell level).
    • Platelet count less than 25,000 cells/µL (low clot‑forming cells).
    • Having taken strong immune‑suppressing medicines such as cyclosporine, voclosporin, tacrolimus, sirolimus, or cyclophosphamide within a period equal to five half‑lives of the drug before randomization.
    • Having taken any of the following within 90 days before randomization: leflunomide, intravenous immunoglobulins, methotrexate, or tyrosine kinase inhibitors.
    • Having taken the drug anifrolumab within 6 months before randomization.
    • Having taken biological immune‑suppressing agents such as anti‑tumor necrosis factor (anti‑TNF), anti‑interleukin‑1 (anti‑IL‑1), or anti‑interleukin‑6 (anti‑IL‑6) therapies within 90 days before randomization.
    • Having taken B‑cell‑depleting biological agents (drugs that reduce a type of white blood cell called B cells) such as rituximab, obinutuzumab, or ocrelizumab within 12 months before randomization.
    • Having taken any of the following at any time before screening: alemtuzumab, sphingosine‑1‑phosphate receptor modulators (for example, fingolimod), or having previously participated in a trial with cenerimod.
    • Being pregnant (confirmed by blood or urine test), planning to become pregnant, or currently breastfeeding.
    • Having a history of other kidney diseases (other than lupus nephritis) that could affect kidney assessment, such as diabetic kidney disease, or requiring dialysis, kidney transplantation, or having end‑stage kidney failure.
    • Having a history or current heart‑rhythm problems such as Mobitz type II or third‑degree atrioventricular block, sick sinus syndrome, symptomatic slow heart rate (bradycardia), or fainting (syncope) linked to heart issues.
    • Having experienced serious heart or blood‑vessel events within the past 6 months, including heart attack, unstable chest pain, stroke, mini‑stroke (transient ischemic attack), blood clot in a vessel, severe heart failure needing hospitalization, or heart failure classified as New York Heart Association Class III/IV.
    • Having a resting heart rate below 50 beats per minute measured on a 12‑lead electrocardiogram (ECG) at screening or randomization.
    • Having an active or latent (hidden) tuberculosis infection at screening or within 6 months before screening.
    • Having a negative antibody test for varicella‑zoster virus (meaning no immunity to chickenpox or shingles).
    • Having a positive test for hepatitis A, B, C, or E indicating a current infection.
    • Having a positive test for human immunodeficiency virus (HIV) or any other congenital or acquired immune‑deficiency condition.
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Investigated drugs

cenerimod is an oral tablet taken once a day. It is designed to affect the immune system, helping to lower the activity that can cause inflammation and damage in the kidneys of people with systemic lupus erythematosus and active lupus nephritis. In this study, participants receive cenerimod along with their usual background treatments for lupus, and researchers watch how well it works to achieve a complete renal response while also monitoring its safety and how well patients tolerate it.

What is already known about the treatment

cenerimod - Cenerimod is taken as a film‑coated tablet by mouth once a day at a dose of 4 mg. It is still an investigational medicine being studied in phase 3 trials and is not yet approved for routine use. The drug is being tested for people with systemic lupus erythematosus and active lupus nephritis, where it aims to improve kidney function. It works by gently blocking a receptor that controls the movement of certain immune cells, helping calm the overactive immune response; it belongs to the class of S1P1 receptor modulators (immunomodulators).

Investigated diseases

Systemic lupus erythematosus with active lupus nephritis - Systemic lupus erythematosus is an autoimmune condition in which the immune system attacks the body’s own tissues, causing inflammation in skin, joints, and other organs. When the kidneys become involved, the disease is called lupus nephritis, leading to swelling, protein loss in the urine, and gradual decline in kidney filtering ability. In the active phase, inflammation intensifies, causing higher protein levels in the urine and a slower drop in kidney function over time. If the inflammation persists, the kidney damage can become more widespread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522984-14-00Protocol codeID-064B301Estimated enrolment300 patientsSponsorViatris Innovation GmbH

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