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Study on the Effects of Vidofludimus Calcium in Adults with Relapsing Multiple Sclerosis

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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 Relapsing Multiple Sclerosis, a condition where the immune system mistakenly attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body. The study is testing a medication called IMU-838, which contains the active substance vidofludimus calcium. This medication is being compared to a placebo to evaluate its effectiveness, safety, and how well it is tolerated by patients.

The purpose of the study is to see if IMU-838 can delay the occurrence of relapses, which are episodes of new or worsening symptoms. Participants in the study will be randomly assigned to receive either the IMU-838 tablets or a placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment.

Throughout the study, participants will take the medication orally in tablet form. The study will monitor the time it takes for participants to experience their first confirmed relapse, as well as other factors like changes in brain lesions seen on MRI scans and any changes in disability levels. The study aims to provide valuable information about the potential benefits of IMU-838 for people with Relapsing Multiple Sclerosis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Upon joining the study, the patient will begin the initial treatment phase. This involves taking either IMU-838 or a placebo. The medication is administered orally in tablet form.

    The dosage for IMU-838 is either 15 mg or 30 mg, depending on the specific group assignment. The tablets are taken once daily.

  2. Step 2

    Monitoring and assessment

    Throughout the trial, the patient's health and response to the treatment will be closely monitored. This includes regular visits to assess any changes in symptoms and overall health.

    Magnetic resonance imaging (MRI) scans will be conducted to evaluate changes in brain lesions and overall brain volume.

  3. Step 3

    Evaluation of relapses

    The primary goal is to determine the time to the first confirmed relapse. This is assessed by an independent committee and occurs after the start of treatment.

    The evaluation period for relapses is up to 72 weeks, with assessments conducted at specific intervals.

  4. Step 4

    Secondary assessments

    Secondary assessments include changes in the total volume of new T2-lesions, time to confirmed disability worsening, and changes in cognitive function as measured by the Symbol Digit Modalities Test.

    These assessments help to provide a comprehensive understanding of the treatment's impact on the patient's condition.

  5. Step 5

    Completion of main period

    The main period of the trial concludes at 72 weeks. At this point, a final evaluation is conducted to assess the overall effectiveness and safety of the treatment.

    Patients who complete the main period may be eligible for an extension period, which involves open-label treatment with IMU-838.

Who can join the trial?

13 criteria

  • Must be a male or female aged between 18 and 55 years.
  • Must have a confirmed diagnosis of **Multiple Sclerosis (MS)** according to specific criteria from 2017.
  • Must have **Relapsing Multiple Sclerosis (RMS)**, which includes types like **Relapsing Remitting MS (RRMS)** and **active secondary progressive MS**. These are defined by certain criteria from 1996 and 2014.
  • Eligible if previous treatments for MS have not worked well, caused side effects, or if there are reasons they cannot take them.
  • Must have an active disease, shown by:
    • At least 2 relapses in the last 24 months, or
    • At least 1 relapse in the last 12 months, or
    • A positive **Gadolinium-enhanced (Gd+) MRI** scan of the brain or spine in the last 12 months.
    • Must have an **EDSS score** between 0 and 5.5. This score measures disability in MS.
    • Female patients must:
      • Be unable to have children (due to surgery or menopause), or
      • If able to have children, have a negative pregnancy test and agree to use effective birth control methods during the trial and for 30 days after.
      • Male patients must agree not to father a child or donate sperm during the trial and for 30 days after. They must use barrier contraception if they have a female partner.
      • Must be willing and able to follow the trial's rules and procedures.
      • Must be able to read and understand the trial information and give written consent to participate.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of multiple sclerosis that is not relapsing. Relapsing means the disease comes and goes, with periods of getting worse and then better.
  • Patients who are not adults. This study is only for adults, which means people who are 18 years or older.
  • Patients who are not experiencing active symptoms of relapsing multiple sclerosis. Active means the symptoms are currently happening or have happened recently.
  • Patients who are part of a vulnerable population that requires special protection. This could include people who might not be able to make decisions for themselves.
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Investigated drugs

IMU-838 is a medication being studied for its effectiveness in treating adults with relapsing multiple sclerosis (RMS). The goal of the trial is to see if IMU-838 can help delay the time until the first relapse of the disease. This medication is being compared to a placebo to determine its safety and how well it works in managing the symptoms of RMS.

What is already known about the treatment

IMU-838 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsing multiple sclerosis. It is in the phase 3 stage of clinical trials, which means it is being tested for efficacy, safety, and tolerability compared to a placebo. The main therapeutic indication for IMU-838 is to delay the occurrence of relapses in patients with active relapsing multiple sclerosis. At the molecular level, IMU-838 works by modulating the immune system to reduce inflammation and prevent damage to nerve cells. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

Relapsing Multiple Sclerosis – This is a chronic disease affecting the central nervous system, characterized by episodes of new or increasing neurological symptoms, known as relapses. These relapses are followed by periods of partial or complete recovery, during which the disease does not progress. Over time, the frequency and severity of relapses may vary, and some individuals may experience a gradual worsening of symptoms. The disease can lead to a range of symptoms, including fatigue, difficulty walking, numbness, and vision problems. The exact cause of relapsing multiple sclerosis is not fully understood, but it involves an abnormal immune response that damages the protective covering of nerve fibers. The progression of the disease can be unpredictable, with some individuals experiencing long periods of stability.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514619-88-00Protocol codeP3-IMU-838-RMS-02Estimated enrolment1 050 patientsSponsorImmunic AG

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