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Study on Tolebrutinib for Patients with Primary Progressive Multiple Sclerosis

Fast replyInvestigationalNo placebo
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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 Primary Progressive Multiple Sclerosis (PPMS), a type of multiple sclerosis that gradually worsens over time. The study is testing a new treatment called Tolebrutinib, which is a medication taken as a film-coated tablet. Tolebrutinib is being compared to a placebo to see if it can help delay the progression of disability in people with PPMS.

The purpose of the study is to determine how effective Tolebrutinib is in slowing down the progression of disability in individuals with PPMS. Participants in the study will be randomly assigned to receive either Tolebrutinib or a placebo. The study is designed to be double-blind, 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 unbiased and reliable.

Throughout the study, participants will be monitored for changes in their condition, including any progression of disability. The study will also look at other factors such as changes in brain volume, cognitive function, and overall quality of life. Safety and tolerability of the medication will be closely observed to ensure the well-being of all participants. The study aims to provide valuable information on whether Tolebrutinib can be a beneficial treatment option for those living with PPMS.

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 participant will be randomly assigned to receive either the study medication, tolebrutinib, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

  2. Step 2

    Medication administration

    The participant will take the assigned medication orally in the form of a film-coated tablet. The specific dosage and frequency will be determined by the study protocol and communicated to the participant at the start of the trial.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the participant will undergo regular assessments to monitor the progression of primary progressive multiple sclerosis (PPMS). These assessments will include evaluations of disability progression, brain imaging, and cognitive function tests.

    The primary goal is to determine if the medication delays disability progression compared to the placebo.

  4. Step 4

    Safety and tolerability checks

    The participant's safety and the tolerability of the medication will be closely monitored. This includes regular check-ups and reporting any side effects experienced during the trial.

  5. Step 5

    End of study

    The study is estimated to conclude by June 28, 2025. At the end of the study, the participant will undergo final assessments to evaluate the overall impact of the treatment on their condition.

Who can join the trial?

7 criteria

  • Must be between 18 to 55 years old.
  • Must have a diagnosis of Primary Progressive Multiple Sclerosis (PPMS) according to specific guidelines from 2017.
  • Must have a score between 2.0 to 6.5 on the Expanded Disability Status Scale (EDSS), which is a way to measure disability in people with multiple sclerosis.
  • Must have positive cerebrospinal fluid oligoclonal bands or an elevated Immunoglobulin G (IgG) index. These are tests that help confirm the diagnosis of multiple sclerosis.
  • Must use birth control methods that follow local rules for people in clinical studies.
  • Must not be pregnant or breastfeeding. If a woman can have children, she must agree to use an acceptable method of birth control.
  • Must not have access to a medication called ocrelizumab, or if they do, they must not tolerate it due to side effects or safety reasons, or it must not work effectively for them.
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Investigated drugs

SAR442168 is a medication being studied for its potential to slow down the progression of disability in people with Primary Progressive Multiple Sclerosis (PPMS). This medication is being compared to a placebo to evaluate its effectiveness and safety in managing the symptoms and progression of this condition.

What is already known about the treatment

SAR442168 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating Primary Progressive Multiple Sclerosis (PPMS). It is in the experimental phase, with ongoing research to determine its safety and efficacy. The main therapeutic indication is to delay disability progression in individuals with PPMS. SAR442168 works by modulating the immune system to reduce inflammation and prevent nerve damage. It is classified as an immunomodulatory agent.

Investigated diseases

Primary Progressive Multiple Sclerosis – This is a form of multiple sclerosis characterized by a gradual worsening of neurological function from the onset of symptoms, without early relapses or remissions. It primarily affects the spinal cord and brain, leading to increasing disability over time. Symptoms may include problems with walking, muscle stiffness, and weakness. Unlike other forms of multiple sclerosis, this type does not have periods of remission, making the progression more continuous. The disease can also affect cognitive functions, leading to difficulties with memory and thinking. Changes in brain volume and the presence of lesions can be observed through imaging techniques like MRI.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514495-41-00Protocol codeEFC16035Estimated enrolment871 patientsSponsorGenzyme Corp.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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