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Study on the Effectiveness and Safety of Frexalimab and Teriflunomide in Adults with Relapsing Multiple Sclerosis

Fast replyRegistered drugNo 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 the effectiveness and safety of a new treatment for multiple sclerosis, specifically for its relapsing forms. 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 administered as a solution for injection, while teriflunomide is taken orally in tablet form.

The purpose of the study is to assess how well frexalimab works compared to teriflunomide in reducing the frequency of relapses in people with relapsing forms of multiple sclerosis. Participants in the study will receive either frexalimab, teriflunomide, or a placebo, which is a substance with no active medication. The study will last for a period of up to 160 weeks, during which participants will be monitored for any changes in their condition, including the number of relapses they experience and any side effects they may encounter.

Throughout the study, various assessments will be conducted, such as MRI scans to detect changes in the brain, and tests to evaluate cognitive function and overall impact on daily life. The study will also monitor for any adverse events or reactions to the medications. The goal is to gather comprehensive data on the safety and effectiveness of frexalimab as a potential new treatment option for individuals with relapsing forms of 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 have an initial visit where your eligibility will be confirmed. This includes a review of your medical history and a physical examination.

    You will be asked to provide information about any previous relapses or MRI scans showing specific brain changes related to multiple sclerosis.

  2. Step 2

    Randomization

    After confirming eligibility, you will be randomly assigned to one of two groups. One group will receive the medication frexalimab, and the other will receive teriflunomide.

    This process is random to ensure the study's fairness and accuracy.

  3. Step 3

    Medication administration

    If you are in the frexalimab group, you will receive this medication through an intravenous infusion, which means it will be given directly into your vein.

    If you are in the teriflunomide group, you will take a 14 mg film-coated tablet orally once a day.

  4. Step 4

    Regular follow-up visits

    You will have regular follow-up visits to monitor your health and the effects of the medication. These visits will include physical exams and possibly MRI scans to check for changes in your condition.

    You will be asked about any side effects or changes in your symptoms.

  5. Step 5

    End of study procedures

    At the end of the study, you will have a final visit to assess your overall health and the impact of the treatment.

    This may include a final physical exam, MRI scans, and discussions about your experience during the trial.

Who can join the trial?

8 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.
    • At least two documented relapses within the previous two years.
    • 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 or spinal cord on an MRI scan, which 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.
    • The study is open to both male and female participants.
    • The study includes participants who are considered part of a vulnerable population, meaning they may need extra protection or care.

Who cannot join the trial?

10 criteria

  • Patients who do not have a diagnosis of multiple sclerosis cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding 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 cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who have allergies to the study medication or similar drugs cannot participate.
  • Patients who have received certain treatments or medications recently 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 number of relapses, which are periods when symptoms of MS get worse.

  • Teriflunomide

    is an existing medication used to treat relapsing forms of multiple sclerosis. It helps to reduce the frequency of relapses by limiting the activity of certain immune cells that can cause damage to the nervous system. Teriflunomide is taken as a daily pill and is designed to help manage the symptoms of MS and slow down the progression of the disease.

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. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for frexalimab is to reduce the frequency of relapses in multiple sclerosis patients. At the molecular level, frexalimab works by targeting specific immune cells to reduce inflammation in the nervous system. It is classified as an immunomodulatory agent.

  • Teriflunomide

    Teriflunomide is taken orally in the form of a tablet and is an established medication used to treat relapsing forms of multiple sclerosis. It is well-documented in medical literature and is commonly prescribed to help manage symptoms and reduce the frequency of relapses. Teriflunomide works by inhibiting the function of certain immune cells, thereby reducing inflammation and damage to the nervous system. It is classified as an immunomodulatory drug.

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 mistakenly attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. The disease can manifest in various forms, with relapsing-remitting multiple sclerosis being the most common, where symptoms flare up and then improve. Over time, multiple sclerosis can cause permanent damage or deterioration of the nerves. Symptoms vary widely and can include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of the disease can lead to increased disability and impact on daily life activities.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514343-29-00Protocol codeEFC17919BEstimated enrolment1 070 patientsSponsorSanofi-Aventis Recherche & Developpement

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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.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).