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Study on Frexalimab for Preserving Insulin Production in Newly Diagnosed Type 1 Diabetes Patients Aged 12-21 on Insulin Therapy

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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 Type 1 diabetes, a condition where the body’s immune system attacks the cells in the pancreas that produce insulin. The study will explore the effects of a new treatment called Frexalimab, which is a type of medication known as a monoclonal antibody. This medication is designed to help preserve the function of the pancreas in producing insulin. Participants in the study will receive either Frexalimab or a placebo, in addition to their regular insulin therapy.

The purpose of the study is to assess the safety and effectiveness of Frexalimab in helping the pancreas continue to produce insulin in people who have recently been diagnosed with Type 1 diabetes. The study will last for a total of 104 weeks, which is about two years. During this time, participants will receive the treatment and be monitored regularly to see how their bodies respond. The study will include both adults and adolescents who are already on insulin therapy.

Throughout the study, participants will undergo various tests and assessments to measure how well their pancreas is functioning and how their diabetes is being managed. The goal is to see if Frexalimab can help maintain insulin production and improve overall diabetes management compared to those who receive a placebo. This research could provide valuable insights into new ways to support people with Type 1 diabetes in managing their condition more effectively.

The research process

The trial runs in 6 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 will be confirmed based on specific criteria, such as having type 1 diabetes and being on insulin therapy for no longer than 90 days.

    A blood test will be conducted to measure your C-peptide levels, which helps assess your body's insulin production.

  2. Step 2

    Randomization

    After confirming eligibility, you will be randomly assigned to receive either the study medication, frexalimab, or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

    Frexalimab is administered as a subcutaneous injection or intravenous (IV) injection.

  3. Step 3

    Treatment period

    The treatment period lasts for 52 weeks. During this time, you will continue your standard insulin therapy alongside the study medication or placebo.

    You will receive the study medication or placebo at regular intervals as determined by the study protocol.

  4. Step 4

    Regular assessments

    Throughout the study, you will attend regular visits to monitor your health and the effects of the treatment. These visits will include blood tests to measure C-peptide levels and other health indicators.

    Your blood glucose levels will be monitored to ensure they remain within a safe range.

  5. Step 5

    Blinded extension

    After the initial 52-week treatment period, there is a 52-week blinded extension phase. During this phase, you will continue to receive either frexalimab or placebo without knowing which one you are receiving.

    The purpose of this extension is to further assess the long-term safety and efficacy of the treatment.

  6. Step 6

    Final assessment

    At the end of the study, a final assessment will be conducted. This will include a comprehensive evaluation of your health and the study's impact on your diabetes management.

    The results will help determine the effectiveness of frexalimab in preserving insulin production in individuals with type 1 diabetes.

Who can join the trial?

13 criteria

  • Participants must have been diagnosed with Type 1 diabetes according to the American Diabetes Association.
  • Participants should have started insulin replacement therapy (a treatment to replace insulin) no more than 90 days before the first screening visit.
  • Participants must be receiving at least one of the following standard treatments for Type 1 diabetes:
    • Insulin hormone replacement therapy with one or multiple daily injections of:
      • Basal insulin (long-acting insulin)
      • Prandial insulin (insulin taken at meal times)
      • Premixed insulin (a combination of different types of insulin)
      • Continuous subcutaneous insulin infusion (CSII), which is a method of delivering insulin through a pump.
      • Participants must test positive for at least one of the following Type 1 diabetes autoantibodies (proteins made by the immune system that mistakenly target the body's own tissues):
        • Glutamic acid decarboxylase (GAD-65)
        • Insulinoma Antigen-2 (IA-2)
        • Zinc-transporter 8 (ZnT8)
        • Insulin (if tested not later than 10 days after starting insulin therapy)
        • Participants must have a random C-peptide level (a measure of insulin production) of at least 0.2 nmol/L at screening.
        • Participants should be vaccinated according to the local vaccination schedule. Non-live vaccines should be given at least 28 days before the study starts, and live vaccines should be given at least 3 months before the study starts.
        • Participants must use contraception methods that comply with local regulations for clinical study participants.

Who cannot join the trial?

10 criteria

  • Participants must not have any other serious health conditions that could interfere with the study.
  • Participants should not be taking any medications that could affect the study results.
  • Participants must not have a history of allergic reactions to the study medication or similar drugs.
  • Participants should not be pregnant or planning to become pregnant during the study.
  • Participants must not have participated in another clinical trial within the last 30 days.
  • Participants should not have any mental health conditions that could affect their ability to follow study instructions.
  • Participants must not have a history of substance abuse within the past year.
  • Participants should not have any infections that require treatment with antibiotics.
  • Participants must not have received any vaccines within 14 days before starting the study.
  • Participants should not have any blood disorders that could affect the study results.
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Investigated drugs

Frexalimab is a type of medication known as a monoclonal antibody. It works by targeting a specific protein in the body called CD40L. This protein is involved in the immune system's response, and by blocking it, frexalimab may help protect the insulin-producing cells in the pancreas. This is particularly important for people with type 1 diabetes, as their bodies mistakenly attack these cells. The goal of using frexalimab in this trial is to see if it can help preserve the function of these cells, allowing them to continue producing insulin naturally, which could reduce the need for insulin injections.

What is already known about the treatment

Frexalimab – Frexalimab is administered as an injection and is currently being studied in clinical trials for its potential use in treating type 1 diabetes. This medication is a monoclonal antibody that works by blocking a specific protein called CD40L, which plays a role in the immune system's attack on insulin-producing cells in the pancreas. The main goal of using frexalimab is to help preserve the function of these cells in people who have recently been diagnosed with type 1 diabetes, potentially reducing their need for insulin therapy. It is classified as an immunomodulatory agent due to its ability to alter immune responses.

Investigated diseases

Type 1 diabetes mellitus – Type 1 diabetes mellitus is a chronic condition where the pancreas produces little or no insulin due to the immune system attacking and destroying insulin-producing cells. This lack of insulin leads to high levels of glucose in the blood. The disease often begins in childhood or adolescence but can develop at any age. Symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The progression involves a continuous need for insulin replacement to manage blood sugar levels effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500531-36-00Protocol codeDRI17476Estimated enrolment373 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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