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Study on the Effects of Riliprubart for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Verified siteInvestigationalNo 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 a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a rare neurological disorder that causes progressive weakness and impaired sensory function in the legs and arms. The study is testing a new treatment called riliprubart, also known by its code name SAR445088. This treatment is given as a solution for injection under the skin, known as subcutaneous use.

The purpose of the study is to evaluate how effective, safe, and tolerable riliprubart is for adults with CIDP. The study is divided into two parts. In the first part, the focus is on how well riliprubart works in three groups of CIDP patients: those who are currently receiving standard treatments, those who do not respond well to standard treatments, and those who have not yet received standard treatments. The second part of the study looks at the long-term safety and tolerability of riliprubart in these patients.

Participants in the study will receive riliprubart and will be monitored for any changes in their condition and any side effects they may experience. The study will also track the number of participants who respond to the treatment and those who experience any adverse events. This research aims to provide more information about riliprubart as a potential treatment option for people living with CIDP.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP), and previous treatment history.

    Participants must have documented vaccinations against certain bacterial infections and agree to use effective birth control methods if applicable.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status and establish a baseline for future comparisons.

    This includes a review of medical history and any previous treatments for CIDP.

  3. Step 3

    Treatment phase a

    Participants receive the study medication, riliprubart, administered as a solution for injection under the skin.

    The focus is on evaluating the effectiveness of the medication in different subgroups of CIDP patients: those treated with standard care, those who did not respond to standard care, and those who have not received standard care.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring is conducted to assess the response to the medication and any side effects.

    Participants are evaluated for improvements or relapses in their condition, and any adverse events are recorded.

  5. Step 5

    Treatment phase b

    The long-term safety and tolerability of riliprubart are assessed.

    Participants continue to receive the medication, and their health is monitored over an extended period.

  6. Step 6

    Final assessment

    A final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

    The study aims to determine the percentage of participants who respond to the treatment and those who remain relapse-free.

Who can join the trial?

10 criteria

  • Must be an adult, at least 18 years old.
  • Must have a confirmed diagnosis of **CIDP** (Chronic Inflammatory Demyelinating Polyradiculoneuropathy), which is a condition affecting the nerves.
  • Must belong to one of these groups:
    • **SOC-Treated**: Currently receiving standard treatment and have shown improvement, but also experienced worsening when treatment was reduced or stopped.
    • **SOC-Refractory**: Did not improve with standard treatment or cannot continue it due to side effects. Must not have received certain treatments recently and have a specific score on a disability scale.
    • **SOC-Naïve**: Have not been treated for CIDP before or stopped treatment for reasons other than lack of response or side effects. Must not have received certain treatments recently and have a specific score on a disability scale.
    • Must have received certain vaccinations within the last 5 years or at least 14 days before starting the study.
    • Female participants must use two methods of birth control and agree not to donate eggs during the study and for a period after.
    • Female participants must have a negative pregnancy test before starting the study.
    • Male participants with partners who can become pregnant must use two methods of birth control during the study and agree not to donate sperm for a period after.
    • Must be able to provide signed consent to participate in the study.

Who cannot join the trial?

8 criteria

  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an allergy to the study medication.
  • Patients who have a condition that affects their immune system.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

SAR445088 is a medication being studied for its effectiveness, safety, and tolerability in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). This study aims to understand how well this medication works in different groups of patients, including those who have been treated with standard care, those who do not respond to standard care, and those who have not received any standard care. The study also looks at the long-term safety and how well patients can tolerate the medication.

What is already known about the treatment

SAR445088 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). It is in the Phase 2 stage of clinical trials, where its efficacy, safety, and tolerability are being evaluated. The main therapeutic indication for SAR445088 is CIDP, a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. The medication works by modulating the immune system to reduce inflammation and prevent nerve damage. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

Chronic Inflammatory Demyelinating Polyradiculoneuropathy – This is a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. It is caused by damage to the myelin sheath, the protective covering of the nerves. The disease progresses slowly, often over several months, and can lead to significant disability if untreated. Symptoms may include tingling or numbness, muscle weakness, and loss of reflexes. The condition can vary greatly in severity and duration among individuals. It is considered a rare disease and can affect people of any age, though it is more common in adults.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512345-16-00Protocol codePDY16744Estimated enrolment98 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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