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Study on the Effectiveness and Safety of Frexalimab and Teriflunomide for 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 the effectiveness and safety of a new treatment for people with multiple sclerosis, specifically those experiencing relapsing forms of the disease. Multiple sclerosis is a condition where the immune system mistakenly attacks the protective covering of nerves, leading to communication problems between the brain and the rest of the body. The study will compare a new medication called frexalimab (also known by its code name SAR441344) with an existing treatment called teriflunomide, which is available as AUBAGIO 14 mg film-coated tablets. Frexalimab is given as a solution for injection, while teriflunomide is taken orally as a tablet.

The purpose of the study is to assess how well frexalimab works compared to teriflunomide in reducing the frequency of relapses in participants with relapsing forms of multiple sclerosis. Participants will be randomly assigned to receive either frexalimab, teriflunomide, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drugs. The study will also involve the use of MRI scans, which are imaging tests that help visualize the brain and spinal cord, to monitor changes in the condition over time.

Throughout the study, participants will receive regular check-ups and monitoring to ensure their safety and to track the effectiveness of the treatments. The study will last for a period of time, during which participants will be closely observed for any changes in their condition, including the number of relapses and any side effects they may experience. The goal is to gather information that could lead to improved treatment options for people living with 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 visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed based on specific criteria, such as your diagnosis of relapsing forms of multiple sclerosis and your medical history.

    You will undergo a series of assessments, including a review of your medical history and a physical examination. This visit will help establish a baseline for your health status before starting the trial.

  2. Step 2

    Randomization

    After the initial assessments, you will be randomly assigned to one of the treatment groups. This means you will either receive the study medication frexalimab or the comparison medication teriflunomide.

    The assignment is random to ensure that the study results are unbiased and reliable.

  3. Step 3

    Treatment phase

    If you are assigned to the frexalimab group, you will receive the medication through an intravenous infusion. The frequency and duration of these infusions will be explained to you by the study team.

    If you are assigned to the teriflunomide group, you will take a 14 mg film-coated tablet orally once daily.

    Throughout the treatment phase, you will have regular visits to monitor your health and the effects of the medication. These visits will include physical exams, blood tests, and other necessary assessments.

  4. Step 4

    Ongoing monitoring

    During the trial, your health will be closely monitored. This includes regular check-ups and assessments to track any changes in your condition.

    You may also undergo MRI scans to evaluate the effects of the treatment on your brain and to detect any new or enlarging lesions.

  5. Step 5

    End of study visit

    At the end of the study period, you will have a final visit. This visit will include a comprehensive assessment of your health and a review of your experience during the trial.

    The study team will discuss the next steps with you, including any follow-up care or additional treatments that may be necessary.

Who can join the trial?

7 criteria

  • The participant must have been diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria. This means the participant has a specific type of multiple sclerosis that comes and goes.
  • The participant has an EDSS score of 5.5 or less at the first visit (Screening Visit). The EDSS score is a way to measure how much the disease affects the participant's ability to move and perform daily activities.
  • The participant must have at least one of the following before the screening:
    • At least one documented relapse (a return of symptoms) within the previous year, OR
    • At least two documented relapses within the previous two years, OR
    • At least one documented Gd enhancing lesion on an MRI scan within the previous year. A Gd enhancing lesion is a specific type of change seen in the brain on an MRI scan that indicates active inflammation.
    • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. This means participants must follow local rules about birth control while in the study.
    • Participants can be of any gender.

Who cannot join the trial?

9 criteria

  • Patients who do not have multiple sclerosis cannot participate. Multiple sclerosis is a condition that affects the brain and spinal cord.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you fit the required age group.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have other significant health issues that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent infection or illness that could affect the study results cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who have received certain treatments or medications that could interfere with the study cannot participate.
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Investigated drugs

  • Frexalimab

    is a medication being studied for its potential to help people with relapsing forms of multiple sclerosis (MS). It works by targeting specific parts of the immune system that are thought to be involved in the inflammation and damage to the nervous system seen in MS. The goal of using frexalimab is to reduce the frequency of relapses, which are episodes when symptoms of MS suddenly get worse.

  • Teriflunomide

    is an existing medication used to treat relapsing forms of multiple sclerosis. It helps to reduce the number of relapses by limiting the activity of certain immune cells that can cause damage to the nervous system. By doing so, teriflunomide aims to slow down the progression of the disease and help manage its symptoms.

What is already known about the treatment

  • Frexalimab

    Frexalimab is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating relapsing forms of multiple sclerosis, a condition where the immune system mistakenly attacks the protective covering of nerves. It is not yet widely used in medicine, as it is still under investigation. The medication works by targeting specific proteins involved in the immune response, helping to reduce inflammation and nerve damage. Frexalimab is classified as an immunomodulatory agent, which means it helps to regulate the immune system's activity.

  • Teriflunomide

    Teriflunomide is taken orally in the form of a tablet and is an established treatment for relapsing forms of multiple sclerosis. It is well-documented in medical literature and is used to help reduce the frequency of flare-ups in patients. The drug works by inhibiting the function of certain immune cells, thereby decreasing inflammation and preventing further damage to the nervous system. Teriflunomide is classified as an immunomodulatory drug, which helps to balance the immune system's activity.

Investigated diseases

Multiple Sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, the disease can cause permanent damage or deterioration of the nerves themselves. The progression of multiple sclerosis can vary widely among individuals, with some experiencing mild symptoms and others facing more severe disability. Common symptoms include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The disease often follows a relapsing-remitting course, where symptoms flare up and then improve, but it can also progress to a more steady decline in function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504358-36-00Protocol codeEFC17919AEstimated enrolment1 104 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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