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Study on the Effectiveness and Safety of Cenerimod for Adults with Moderate to Severe Systemic Lupus Erythematosus

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called cenerimod in individuals with systemic lupus erythematosus (SLE), a condition where the immune system attacks the body's own tissues, causing inflammation and damage. The study aims to evaluate how effective and safe cenerimod is in reducing the activity of this disease. Participants in the study will receive either cenerimod or a placebo, which is a substance with no active medication, to compare the outcomes.

The study will involve taking cenerimod in the form of a film-coated tablet, which is taken orally, meaning it is swallowed. The treatment period will last for up to 12 months. During this time, participants will continue their usual background therapy for SLE, which may include medications like antimalarials, mycophenolate mofetil, azathioprine, methotrexate, oral corticosteroids, or belimumab. The goal is to see if adding cenerimod to these existing treatments can further reduce the symptoms of SLE.

Throughout the study, participants will be monitored to assess their response to the treatment, focusing on improvements in disease symptoms and overall health. The study will also track any side effects to ensure the safety of cenerimod. By the end of the study, researchers hope to determine if cenerimod is a beneficial addition to the treatment options for people with moderate to severe systemic lupus erythematosus.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either the study medication, cenerimod, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.

    The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.

  2. Step 2

    Medication administration

    If you are assigned to the cenerimod group, you will take a 4 mg film-coated tablet of cenerimod once daily by mouth.

    The duration of the treatment is planned for up to 12 months, during which you will continue your regular background therapy for systemic lupus erythematosus (SLE).

  3. Step 3

    Regular check-ups

    Throughout the study, you will have regular visits with the study team to monitor your health and the effects of the treatment.

    These visits will include physical examinations, blood tests, and assessments of your SLE symptoms to ensure your safety and to evaluate the effectiveness of the treatment.

  4. Step 4

    Completion of the study

    At the end of the 12-month period, your participation in the study will conclude.

    You will have a final visit to assess your health and discuss any further steps or treatments that may be necessary.

Who can join the trial?

17 criteria

  • Sign an Informed Consent Form before any study procedures begin.
  • Have a diagnosis of Systemic Lupus Erythematosus (SLE) for at least 6 months, based on specific medical criteria.
  • Have a modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score of 6 or higher, with a clinical score of 4 or higher. This score measures the activity of lupus in the body. At least 2 points should be for symptoms like muscle inflammation, joint pain, skin rash, hair loss, or mouth sores.
  • Currently taking one or more of the following lupus medications:
    • Antimalarials (up to 400 mg/day hydroxychloroquine, 500 mg/day chloroquine, or 100 mg/day quinacrine)
    • Mycophenolate mofetil (up to 2 g/day) or mycophenolic acid (up to 1.44 g/day)
    • Azathioprine (up to 2 mg/kg/day)
    • Methotrexate (up to 25 mg/week)
    • Oral Corticosteroids (OCS): If this is the only lupus medication, the dose should be between 7.5 mg/day and 30 mg/day prednisone or equivalent. If not the only medication, up to 30 mg/day prednisone or equivalent.
    • Belimumab (up to 10 mg/kg every 4 weeks intravenously or 200 mg/week subcutaneously)
    • Have been on the above medications for at least 90 days before the screening, except for OCS, which should be started at least 30 days before.
    • For women who can become pregnant:
      • Have a negative blood pregnancy test at screening.
      • Agree to monthly urine pregnancy tests from the start of the study until 6 months after stopping the study treatment.
      • Agree to use a highly effective birth control method from the start of the study until 6 months after stopping the study treatment.
      • Have a British Isles Lupus Assessment Group-2004 (BILAG) Grade B in 2 or more organ systems or a Grade A in 1 or more organ system. This is another way to measure lupus activity.
      • Have a Physician's Global Assessment (PGA) score of 1.0 or higher on a scale from 0 to 3. This is a doctor's overall assessment of lupus activity.
      • Show signs of active lupus in blood tests, such as elevated anti-dsDNA antibodies, antinuclear antibodies with a titer of at least 1:160, or elevated anti-Smith antibody.
      • For women who can become pregnant, have a negative urine pregnancy test at the time of randomization.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent infection that required treatment.
  • Patients who have received certain medications that might affect the study results.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have participated in another clinical trial recently.
  • Patients with known allergies to the study medication or similar drugs.
  • Patients who have had a recent surgery or are planning to have surgery during the study.
  • Patients with certain heart conditions.
  • Patients with uncontrolled high blood pressure.
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Investigated drugs

Cenerimod is a medication being studied for its potential to help people with systemic lupus erythematosus (SLE), which is a condition where the immune system attacks the body's own tissues. This medication works by targeting a specific part of the immune system to reduce inflammation and disease activity. The goal of using cenerimod in this trial is to see if it can effectively lower the symptoms and improve the quality of life for people with moderate-to-severe SLE when used alongside their usual treatments.

What is already known about the treatment

Cenerimod – Cenerimod is an oral medication currently being studied in clinical trials for its potential to treat moderate to severe systemic lupus erythematosus (SLE), a chronic autoimmune disease. It is in the advanced stages of research, specifically a Phase 3 trial, which means it is being tested for effectiveness, safety, and tolerability. The main therapeutic use of cenerimod is to reduce disease activity in SLE patients. At the molecular level, cenerimod works by modulating the S1P1 receptor, which plays a role in immune system regulation. It is classified pharmacologically as an S1P1 receptor modulator.

Investigated diseases

Systemic Lupus Erythematosus – Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease often begins with symptoms such as fatigue, joint pain, and skin rashes. As it progresses, individuals may experience more severe symptoms like inflammation of the kidneys, neurological issues, and blood disorders. The disease is characterized by periods of flares, where symptoms worsen, and remissions, where symptoms improve. Over time, SLE can lead to chronic pain and damage to affected organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515871-37-00Protocol codeID-064A302Estimated enrolment420 patientsSponsorViatris Innovation GmbH

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