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Study on Frexalimab, SAR442970, and Rilzabrutinib for Patients Aged 16-75 with Focal Segmental Glomerulosclerosis or Minimal Change Disease

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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 two kidney diseases: Primary Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD). These are conditions that affect the kidney's ability to filter waste and excess fluids from the blood. The study will evaluate the effectiveness and safety of three treatments: Frexalimab, SAR442970, and Rilzabrutinib. Frexalimab and SAR442970 are given as injections, while Rilzabrutinib is taken as a tablet. The study also includes a placebo group for comparison.

The purpose of the study is to see how well these treatments can reduce protein levels in the urine, which is a sign of kidney damage. Participants in the study will receive one of the treatments or a placebo and will be monitored over a period of time to assess changes in their condition. The study will also track any side effects or adverse reactions to the treatments.

Participants will be randomly assigned to receive either Frexalimab, SAR442970, Rilzabrutinib, or a placebo. The study will be conducted in a way that neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. The trial aims to provide valuable information on the potential benefits and risks of these treatments for people with FSGS or MCD.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to receive one of the study medications or a placebo. A placebo is a substance that looks like the medication but does not contain the active ingredient.

  2. Step 2

    Medication administration

    You may receive one of the following medications: frexalimab, SAR442970, or rilzabrutinib. The method of administration will depend on the medication you are assigned.

    Frexalimab will be given as a solution for injection through a vein (intravenous use).

    SAR442970 will be given as a solution for injection under the skin (subcutaneous use).

    Rilzabrutinib will be taken orally in the form of a tablet.

  3. Step 3

    Treatment duration

    The duration of the treatment will be specified by the study team. You will be informed about the frequency and dosage of the medication you are assigned to.

  4. Step 4

    Monitoring and assessments

    Throughout the study, you will undergo regular monitoring and assessments to evaluate the effects of the medication. This will include measuring the reduction in protein levels in your urine, which is an important indicator of the treatment's effectiveness.

    You will also be monitored for any side effects or adverse reactions to the medication.

  5. Step 5

    End of study

    At the end of the study, you will have a final assessment to determine the overall impact of the treatment. You will be informed about the results and any further steps if necessary.

Who can join the trial?

10 criteria

  • Must have a biopsy-proven diagnosis of primary FSGS or primary MCD. A biopsy is a medical test where a small piece of tissue is taken from the body to be examined.
  • Must have a UPCR of 3 grams per gram or higher at screening. UPCR stands for Urine Protein to Creatinine Ratio, which measures protein levels in urine.
  • Must have an eGFR of 45 milliliters per minute per 1.73 square meters or higher at screening. eGFR is a test that measures how well the kidneys are working.
  • Must have a documented history of reducing UPCR by 40% or more in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was 3.5 grams per gram or higher.
  • Must be taking 10 milligrams per day or less of prednisone or an equivalent medication, and this dose must be stable starting at least 1 week before randomization. Prednisone is a type of medication used to reduce inflammation.
  • If applicable, must be on a stable dose of RAAS inhibitors for 4 weeks or more before screening. RAAS inhibitors are medications that help control blood pressure and protect the kidneys.
  • If applicable, must be on a stable dose of SGLT2 inhibitors for 4 weeks or more before screening. SGLT2 inhibitors are medications that help control blood sugar levels.
  • Must have a body weight between 45 to 120 kilograms (inclusive) at screening.
  • Both male and female participants are eligible.
  • Participants from vulnerable populations are eligible. Vulnerable populations may include groups like children, elderly, or those with certain health conditions.

Who cannot join the trial?

5 criteria

  • Patients with **immune system diseases** cannot participate. The immune system is the body's defense against infections and illnesses.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of people.
  • Patients who are not male or female cannot participate. The study includes both male and female participants.
  • Patients who are considered part of a **vulnerable population** cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • Frexalimab

    is a medication being studied for its potential to help people with certain kidney conditions, specifically primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD). These conditions can cause the kidneys to leak protein into the urine, which is not normal. Frexalimab is being tested to see if it can reduce this protein leakage, which might help improve kidney function and overall health.

  • SAR442970

    is another medication included in the study, aimed at treating kidney conditions like FSGS and MCD. The goal of using SAR442970 is to see if it can lower the amount of protein that leaks into the urine. By doing so, it may help protect the kidneys and improve the health of people with these conditions.

  • Rilzabrutinib

    is also part of the clinical trial, and it is being tested for its effectiveness in treating FSGS and MCD. This medication is being evaluated to determine if it can help reduce proteinuria, which is the presence of excess protein in the urine. By reducing proteinuria, rilzabrutinib may help improve kidney function and benefit patients with these kidney diseases.

What is already known about the treatment

  • Frexalimab

    Frexalimab is administered orally and is currently being studied in clinical trials for its potential to treat immune system diseases, specifically primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD). It is in the experimental phase and not yet widely recognized in medical literature. The medication works by targeting specific pathways in the immune system to reduce inflammation and proteinuria, which is the presence of excess protein in the urine. Frexalimab is classified as an immunomodulatory agent, meaning it helps regulate or normalize the immune system.

  • SAR442970

    SAR442970 is taken orally and is under investigation in clinical trials for its effectiveness in treating immune-related conditions like primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD). It is still in the research phase and not yet established in medical practice. The drug functions by modulating immune responses to decrease inflammation and proteinuria. SAR442970 falls under the category of immunomodulatory drugs, which are designed to adjust the immune system's activity.

  • Rilzabrutinib

    Rilzabrutinib is an oral medication currently being evaluated in clinical trials for its potential to treat immune system disorders, particularly primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD). It is not yet approved for general medical use. The drug works by inhibiting specific enzymes in the immune system, thereby reducing inflammation and proteinuria. Rilzabrutinib is classified as a Bruton’s tyrosine kinase (BTK) inhibitor, which helps control immune system activity.

Investigated diseases

  • Focal Segmental Glomerulosclerosis (FSGS)

    Focal Segmental Glomerulosclerosis is a disease that affects the kidney's filtering units, known as glomeruli. It is characterized by scarring (sclerosis) in some of the glomeruli, which can lead to proteinuria, where protein is lost in the urine. Over time, this scarring can impair kidney function, leading to a decrease in the kidneys' ability to filter waste from the blood. The disease can progress at varying rates, and the extent of kidney damage can differ among individuals. FSGS can occur as a primary condition or secondary to other diseases. The exact cause of primary FSGS is often unknown, but it involves immune system dysfunction.

  • Minimal Change Disease (MCD)

    Minimal Change Disease is a kidney disorder that leads to nephrotic syndrome, characterized by high levels of protein in the urine, low levels of protein in the blood, swelling, and high cholesterol. Despite significant proteinuria, the kidney tissue appears nearly normal under a regular microscope, hence the name "minimal change." The disease primarily affects children but can also occur in adults. The exact cause of MCD is not well understood, but it is believed to involve immune system abnormalities. The condition can lead to a rapid onset of symptoms, but kidney function typically remains normal. MCD is often responsive to treatment, although relapses can occur.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511775-15-00Protocol codeACT18064Estimated enrolment107 patientsSponsorSanofi-Aventis Recherche & Developpement

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