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A study to compare the effectiveness and safety of subcutaneous frexalimab versus intravenous frexalimab in adults with multiple sclerosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates the use of frexalimab in adults living with multiple sclerosis, a condition where the body's immune system attacks the protective covering of nerves. The purpose of the study is to compare two different ways of giving this medication to see if one is as effective as the other. One method involves intravenous administration, which means the medicine is delivered directly into a vein, while the other method is subcutaneous, meaning the medicine is injected into the fatty tissue just under the skin.

Participants will be monitored to observe how the drug moves through the body, a process known as pharmacokinetics, and to ensure the treatment is safe. The study will track how much of the medicine remains in the blood over time and check for any side effects. Researchers will also look at changes in the brain using MRI to identify Gd-enhancing T1 lesions, which are small areas of inflammation or damage that can be seen on specific scans. Additionally, the study will monitor any changes in physical ability to understand how the disease progresses over time.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Administration of medication

    The medication frexalimab is administered either through an intravenous injection (into a vein), a subcutaneous injection (under the skin), or an intramuscular injection (into a muscle).

    The dose of frexalimab is 1800 mg (milligrams) provided as a solution for injection.

  2. Step 2

    Initial observation period

    During the first 24 weeks, monitoring of how the body processes the medication and the levels of the drug in the blood is conducted.

    At week 12 and week 24, assessments are made to count gadolinium-enhancing T1 lesions, which are specific areas of activity seen on an MRI scan.

  3. Step 3

    Extended monitoring phase

    From week 24 up to week 96, monitoring continues for safety and side effects, including adverse events (unwanted medical occurrences), vital signs (such as blood pressure and heart rate), and laboratory tests.

    The occurrence of antibodies (proteins produced by the immune system that may react against the drug) is tracked up to week 96.

    The time it takes for any confirmed disability worsening or progression to occur is monitored until week 96.

  4. Step 4

    Long-term follow-up

    Starting at week 96 and continuing yearly thereafter, the number of gadolinium-enhancing T1 lesions is monitored to observe long-term effects.

Who can join the trial?

11 criteria

  • For participants in the first group, you must be between 18 and 55 years old when you sign the study agreement.
  • For participants in the second group, you must be between 18 and 60 years old when you sign the study agreement.
  • Participants in the second group must have an EDSS score (a scale used to measure how much disability a person has due to their condition) between 3.0 and 6.5 at the first visit.
  • Both groups must use contraception (methods used to prevent pregnancy) in a way that follows local rules for people in medical studies.
  • Participants in the first group must have been diagnosed with Relapsing-Remitting Multiple Sclerosis (RMS), which is a form of the disease where symptoms appear and then go away, based on specific medical standards.
  • Participants in the first group must have an EDSS score (a tool to measure physical disability) of 5.5 or less at the first visit.
  • Participants in the first group must have had at least one relapse (a sudden worsening of symptoms) in the last year, or at least two relapses in the last two years, or at least one Gd enhancing lesion (an area of inflammation or damage seen on an MRI scan) in the last year.
  • Participants in the second group must have a previous diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) based on specific medical standards.
  • Participants in the second group must have a current diagnosis of Secondary Progressive Multiple Sclerosis (SPMS), which is a stage where the disease begins to progress more steadily, based on specific medical standards.
  • Participants in the second group must have proof that their disability progressed (gotten worse) during the 12 months before joining the study.
  • Participants in the second group must not have had any clinical relapses (episodes of new or worsening symptoms) for at least 24 months.

Who cannot join the trial?

10 criteria

  • You have been diagnosed with primary progressive multiple sclerosis, which is a specific type of the disease that gets worse steadily over time.
  • You have a history of infections (illnesses caused by germs) or you are currently at a high risk of getting an infection.
  • You have had a fever (a body temperature higher than normal) within the 28 days before your first study visit.
  • You have any psychiatric disturbances (mental health conditions) or a history of substance abuse (misuse of drugs or alcohol).
  • You have a history of, or are at risk for, thromboembolic events, which are serious issues like blood clots moving through the blood vessels.
  • You have had a myocardial infarction (a heart attack), a stroke (when blood flow to the brain is blocked), or antiphospholipid syndrome (a condition that causes blood to clot too easily).
  • You are currently taking antithrombotic treatment (medicine used to prevent blood clots).
  • You have hypogammaglobulinemia, which means your body does not have enough immunoglobulins (proteins in the blood that help fight infections), or you have a history of this condition.
  • You have a history of or currently have any other disease that could cause symptoms similar to multiple sclerosis.
  • You have a contraindication for MRI, which means there is a medical reason or safety concern that prevents you from having a magnetic resonance imaging scan.
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Investigated drugs

Frexalimab is a medication being tested to see how well it works and how safe it is for adults living with multiple sclerosis. This study is looking at two different ways to give this medicine: through an injection under the skin or through an IV into a vein.

What is already known about the treatment

Frexalimab - This medication is an experimental drug currently being studied in clinical trials, provided as a solution for injection via an IV drip, under the skin, or into a muscle. It is being developed to treat multiple sclerosis by targeting specific parts of the immune system to prevent it from attacking the protective covering of nerves. This drug works by blocking a particular protein on immune cells, which helps to reduce the harmful inflammation that causes nerve damage. It is classified as a monoclonal antibody designed to regulate the body's immune response.

Investigated diseases

Multiple Sclerosis - This is a condition where the body's immune system attacks the protective covering of the nerves. This process causes damage to the central nervous system, which includes the brain and spinal cord. As the disease develops, it can lead to the formation of scar tissue or lesions along the nerve pathways. These changes disrupt the communication signals between the brain and the rest of the body. The progression can involve various stages of neurological changes over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519304-28-00Protocol codeEFC18098Estimated enrolment213 patientsSponsorSanofi-Aventis Recherche & Developpement

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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