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Study on the Effects of Vidofludimus Calcium (IMU-838) in Patients with Progressive 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 Progressive Multiple Sclerosis, a type of multiple sclerosis where symptoms gradually worsen over time. The study is testing a medication called IMU-838, which is taken in tablet form. The trial will compare the effects of IMU-838 to a placebo to see how well it works and how safe it is for patients with this condition.

The purpose of the study is to evaluate the effectiveness of IMU-838 in slowing down brain shrinkage, which is a common issue in progressive multiple sclerosis. Participants will be randomly assigned to receive either the IMU-838 tablets or a placebo. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, ensuring unbiased results.

Throughout the study, participants will undergo regular assessments, including MRI scans, to monitor changes in brain volume and any progression in disability. The study aims to provide valuable information on whether IMU-838 can help manage the symptoms of progressive multiple sclerosis and improve the quality of life for those affected by this condition.

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

    Joining the study

    Upon joining the study, the patient will be randomly assigned to receive either the IMU-838 medication or a placebo. This process is double-blind, meaning neither the patient nor the researchers know which treatment the patient is receiving.

  2. Step 2

    Medication administration

    The patient will take the assigned medication orally in the form of tablets. The options include IMU-838 at a dosage of either 22.5 mg or 45 mg, or a placebo tablet.

    The medication is to be taken as prescribed by the study protocol, which will specify the exact dosage and frequency.

  3. Step 3

    Main treatment period

    During the main treatment period, the patient will continue taking the medication as directed. This period is designed to evaluate the effectiveness of IMU-838 in treating progressive multiple sclerosis.

    The primary focus is on measuring changes in brain volume using MRI scans, which will help assess the medication's impact on brain atrophy.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the patient will undergo regular assessments to monitor their health and the progression of their condition. This includes MRI scans and evaluations of disability status using the expanded disability status scale (EDSS).

    These assessments are crucial for determining the time to any confirmed disability worsening over a 24-week period.

  5. Step 5

    Open-label extension period

    After completing 120 weeks of the main treatment period, or upon experiencing confirmed disability worsening, the patient may enter the open-label extension period.

    During this phase, all patients will receive IMU-838, allowing for further evaluation of its long-term effects.

Who can join the trial?

10 criteria

  • Must be an adult between 18 and 65 years old.
  • No signs of a relapse in the last 24 months before joining the study.
  • Must have a type of Multiple Sclerosis called either SPMS (Secondary Progressive Multiple Sclerosis) or PPMS (Primary Progressive Multiple Sclerosis). SPMS can be with or without certain brain or spinal cord changes seen in an MRI scan in the last 12 months. PPMS should be diagnosed according to specific guidelines and should have been present for 10 years or less.
  • Must have an EDSS score between 3.0 and 6.5. The EDSS is a scale used to measure disability in people with Multiple Sclerosis.
  • Must show signs of worsening disability not linked to a relapse in the last 24 months, confirmed by a reviewer. This can be shown by an increase in the EDSS score, a 20% or more worsening in walking or hand function tests, or a written summary of worsening from medical records.
  • Female participants must either be unable to have children (due to surgery or menopause) or, if they can have children, must have a negative pregnancy test and agree to use effective birth control methods during the study and for 30 days after.
  • Male participants must agree not to father a child or donate sperm during the study and for 30 days after. They must use barrier contraception if they have a female partner, and if the partner can have children, she should use effective birth control methods.
  • Must be willing and able to follow the study rules.
  • Must provide written consent to participate in the study before any study-related procedures begin.
  • For the OLE (Open-Label Extension) period, participants must have completed 120 weeks of the main treatment period or have confirmed disability worsening over 24 weeks, or be in the main treatment period when the study reaches a specific event, allowing them to enter the OLE treatment period.

Who cannot join the trial?

5 criteria

  • Patients with any other type of Multiple Sclerosis that is not a progressive form. Progressive forms mean the disease is getting worse over time.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population. This means groups of people who might need special protection or care.
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Investigated drugs

IMU-838 is a medication being studied for its potential to help patients with progressive multiple sclerosis. The trial aims to see how well this medication works in slowing down brain shrinkage, which is a common issue in this condition. The study uses advanced imaging techniques to measure changes in the brain, helping researchers understand the medication's effectiveness.

What is already known about the treatment

IMU-838 – IMU-838 is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating progressive forms of Multiple Sclerosis. The main therapeutic indication for IMU-838 is to slow down brain atrophy in patients with this condition. At the molecular level, IMU-838 works by inhibiting an enzyme involved in the synthesis of pyrimidines, which are essential for the proliferation of immune cells, thereby reducing inflammation. It is classified as an immunomodulatory agent.

Investigated diseases

Progressive Multiple Sclerosis – Progressive Multiple Sclerosis is a form of multiple sclerosis characterized by a gradual worsening of neurological function over time. Unlike relapsing forms, it does not have clear periods of remission. The disease affects the central nervous system, leading to symptoms such as muscle weakness, difficulty with coordination and balance, and cognitive changes. As the disease progresses, individuals may experience increased disability. The progression can vary significantly from person to person, with some experiencing a slow decline and others a more rapid deterioration. The exact cause of the disease is not fully understood, but it involves an abnormal immune response that damages the protective covering of nerve fibers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514617-35-00Protocol codeP2-IMU-838-PMSEstimated enrolment467 patientsSponsorImmunic AG

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