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Study on Long-term Safety and Efficacy of Riliprubart for Patients 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), which is a disease affecting the immune system. The study is evaluating a treatment known as riliprubart, also referred to by its code name SAR445088. Riliprubart is administered as a solution for injection using a pre-filled pen. The main goal of this study is to assess the long-term safety and tolerability of riliprubart in individuals with CIDP.

Participants in this study will receive riliprubart through subcutaneous injections, which means the medication is injected under the skin. The study will monitor participants over an extended period to observe any side effects or adverse events that may occur. Additionally, the study will track the percentage of participants who remain free from relapses and those who show improvement in their condition. Changes in disability scores, grip strength, and muscle strength will also be measured to evaluate the effectiveness of the treatment.

The study is designed to provide valuable information about the long-term use of riliprubart in managing CIDP. By participating in this study, researchers aim to gather data that could help improve treatment options for individuals living with this chronic condition. The study is expected to continue until 2029, allowing for comprehensive observation and analysis of the treatment's impact 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

    Joining the study

    Upon joining the study, participants will be required to provide signed informed consent. This consent confirms understanding and agreement to comply with the study's requirements and restrictions.

  2. Step 2

    Medication administration

    Participants will receive the medication riliprubart through a subcutaneous injection. This means the medication is injected under the skin using a pre-filled pen designed for this purpose.

    The frequency and dosage of the medication will be determined by the study protocol and communicated to participants by the study team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular monitoring to assess the safety and effectiveness of the medication. This includes checking for any adverse events or side effects, as well as conducting laboratory tests, electrocardiograms (ECGs), and measuring vital signs.

    Participants will also be evaluated for improvements in their condition, such as changes in disability scores, grip strength, and muscle strength.

  4. Step 4

    Completion of the study

    The study is expected to continue until July 31, 2029. Participants will be informed about the completion process and any follow-up requirements as the study progresses.

Who can join the trial?

4 criteria

  • Participants must have chronic inflammatory demyelinating polyneuropathy (CIDP) and be currently receiving the study medication called riliprubart.
  • Participants must have completed treatment in one of the following studies: Study PDY16744, Study EFC17236, or Study EFC18156. If participating in Part C of Study PDY16744, they must have completed the Part C End of Treatment visit.
  • All participants must agree to use birth control methods during and after the study as required. This applies to both men and women and should follow local rules about birth control for clinical study participants.
  • Participants must be able to give signed informed consent, which means they understand the study and agree to follow the study rules and restrictions.

Who cannot join the trial?

1 criterion

  • Participants with immune system diseases cannot join. This means if your body's defense system, which fights off illnesses, is not working properly, you cannot participate.
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Investigated drugs

Riliprubart is a medication being studied for its effects on a condition called chronic inflammatory demyelinating polyneuropathy, or CIDP. CIDP is a disorder that affects the nerves, causing weakness and numbness. The purpose of this study is to see how safe and well-tolerated riliprubart is when used over a long period. Researchers want to understand if it can help manage the symptoms of CIDP and improve the quality of life for people with this condition. By participating in this study, patients will help determine if riliprubart can be a reliable treatment option for CIDP in the future.

What is already known about the treatment

Riliprubart – Riliprubart is administered to patients through a method that is determined by healthcare professionals, typically involving injections or infusions. It is currently being studied in clinical trials to assess its long-term safety and effectiveness for treating chronic inflammatory demyelinating polyneuropathy (CIDP), a disease affecting the immune system. The medication works by modulating the immune system to reduce inflammation and prevent damage to nerve cells. Riliprubart is classified as an immunomodulatory agent, which means it helps regulate the immune system's activity to treat diseases.

Investigated diseases

Chronic Inflammatory Demyelinating Polyneuropathy – Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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, due to an abnormal immune response. The disease typically progresses slowly, with symptoms that may include tingling or numbness, muscle weakness, and loss of reflexes. Over time, individuals may experience difficulty with coordination and balance. The progression of CIDP can vary, with some experiencing periods of improvement and others having a steady decline in function. The condition is considered rare and can affect individuals differently, with varying degrees of severity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517032-22-00Protocol codeLTS17261Estimated enrolment359 patientsSponsorSanofi-Aventis Recherche & Developpement

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