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Study on Frexalimab for Treating Active Systemic Lupus Erythematosus in Patients

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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 treatment called Frexalimab (also known by its code name SAR441344) for individuals with a condition known as Systemic Lupus Erythematosus (SLE). SLE is an autoimmune disease, which means the body's immune system mistakenly attacks its own tissues, causing inflammation and damage to various parts of the body. The study aims to evaluate how well Frexalimab works in reducing the activity of the disease over a period of 24 weeks.

Participants in the study will receive either Frexalimab or a placebo, in addition to their usual care. The treatment is given as a solution for injection, which can be administered either intravenously (directly into a vein) or subcutaneously (under the skin). The study will last for several months, during which participants will be monitored to assess the impact of the treatment on their condition. The goal is to determine if Frexalimab can help reduce the symptoms and improve the quality of life for those living with SLE.

Throughout the study, various health assessments will be conducted to ensure the safety of the participants and to gather information on how the treatment affects the disease. This includes monitoring for any side effects and measuring the levels of the drug in the body. The study will also look at how the treatment influences the need for other medications, such as corticosteroids, which are often used to manage SLE symptoms. The findings from this trial will contribute to understanding the potential benefits of Frexalimab for people with SLE.

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, an initial visit is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests are performed to check for specific markers related to systemic lupus erythematosus (SLE).

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the investigational medication frexalimab or a placebo. A placebo is a substance with no active medication, used for comparison.

    The study is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Treatment administration

    The treatment involves receiving frexalimab or placebo as a solution for injection. This can be administered either intravenously (IV) or subcutaneously (SC).

    The treatment period lasts for 24 weeks, with regular administration as per the study protocol.

  4. Step 4

    Regular follow-up visits

    Participants attend regular follow-up visits to monitor health and response to treatment. These visits include physical examinations and laboratory tests.

    The frequency of these visits is determined by the study schedule, ensuring close monitoring of any changes in health status.

  5. Step 5

    Assessment of treatment response

    At week 24, the primary assessment of treatment response is conducted. This involves evaluating the percentage of participants achieving a specific response index for SLE.

    Secondary assessments include various health indicators and the impact on symptoms such as joint tenderness and skin conditions.

  6. Step 6

    End of study evaluation

    At the end of the study period, a final evaluation is conducted to assess overall health and any changes since the start of the trial.

    Participants may be asked to provide feedback on their experience and any side effects encountered during the study.

Who can join the trial?

10 criteria

  • Must have been diagnosed with Systemic Lupus Erythematosus (SLE) for at least 6 months before joining the study. This diagnosis should meet specific criteria set in 1997.
  • Must have a positive ANA test (a blood test that looks for certain antibodies) with a titer of 1:80 or higher during the screening process.
  • Must test positive for at least one specific serological characteristic (a blood test that looks for certain markers related to SLE).
  • Must have a hSELENA-SLEDAI score of 6 or higher during screening. This score measures disease activity and should include points from arthritis and rash. At least 4 points should come from clinical features at the time of randomization, confirmed by an independent reviewer.
  • Must have at least 1 BILAG A score or 2 BILAG B scores during screening, confirmed by an independent reviewer. These scores are used to assess the severity of SLE symptoms.
  • Must be receiving at least one of the standard treatments for SLE. It is possible to be on a combination of these treatments.
  • Body weight must be between 45 kg and 120 kg (inclusive) at the time of screening.
  • Must use contraception if required by local regulations for clinical study participants. This applies to both men and women.
  • Both men and women can participate in the study.
  • Participants must be within the age range specified for the study.

Who cannot join the trial?

10 criteria

  • Patients with a history of severe allergic reactions to any of the study medications cannot participate.
  • Patients who are currently pregnant or breastfeeding are not eligible.
  • Patients with any other serious health conditions that might interfere with the study cannot join.
  • Patients who have participated in another clinical trial within the last 30 days are excluded.
  • Patients with a history of drug or alcohol abuse in the past year are not allowed to participate.
  • Patients who are unable to comply with the study procedures and visits are not eligible.
  • Patients with active infections that require treatment are excluded.
  • Patients who have received certain medications that might interfere with the study within the last 30 days cannot participate.
  • Patients with a history of cancer within the last 5 years, except for certain types of skin cancer, are not eligible.
  • Patients with a history of certain autoimmune diseases, other than **systemic lupus erythematosus**, are excluded.
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Investigated drugs

SAR441344 is a medication being tested to see if it can help people with Systemic Lupus Erythematosus (SLE), which is a disease where the immune system attacks the body. This medication is being studied to find out if it can reduce the symptoms of SLE when used alongside the usual treatments that patients already receive. The goal is to see if it can make patients feel better over a period of 24 weeks.

What is already known about the treatment

SAR441344 – SAR441344 is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its potential use in treating systemic lupus erythematosus, a chronic autoimmune disease. The medication works by targeting specific proteins in the immune system to reduce inflammation and disease activity. It is classified as an immunomodulatory agent, which means it helps regulate the immune system's response.

Investigated diseases

Systemic lupus erythematosus – Systemic lupus erythematosus is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease often presents with symptoms such as fatigue, joint pain, skin rashes, and fever. Over time, it can lead to inflammation and damage in the affected organs. The progression of the disease can vary greatly among individuals, with periods of flares and remissions. The exact cause of systemic lupus erythematosus is not fully understood, but it is believed to involve a combination of genetic, environmental, and hormonal factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508654-26-00Protocol codeACT17010Estimated enrolment210 patientsSponsorSanofi-Aventis Recherche & Developpement

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