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Study on the Effects and Safety of Riliprubart for Patients with Chronic Inflammatory Demyelinating Polyneuropathy Unresponsive to Usual Treatments

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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, which is given as a solution for injection. The purpose of the study is to evaluate the effects and safety of riliprubart in people with CIDP for whom the usual treatments do not work.

Participants in the study will receive either riliprubart or a placebo, which is a substance with no active medication. The study will be conducted over a period of time, during which participants will receive regular injections and attend follow-up visits to monitor their health and the effects of the treatment. The study aims to assess how well riliprubart works in improving the symptoms of CIDP and its long-term effects on the condition.

Throughout the study, participants will be closely monitored for any changes in their condition and any side effects they may experience. The study will use various measures to evaluate the effectiveness of riliprubart, including changes in disability scores and grip strength. The goal is to determine if riliprubart can provide a meaningful improvement for people with CIDP who have not responded to other treatments.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) and ensuring that previous treatments have been ineffective.

    The assessment involves reviewing medical history, current medications, and conducting necessary tests to establish a baseline for the study.

  2. Step 2

    Treatment phase

    Participants receive the study medication, riliprubart, or a placebo. The medication is administered through intravenous infusion or subcutaneous injection.

    The dosage and frequency of administration are determined by the study protocol and are monitored closely by the study team.

  3. Step 3

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor the participant's response to the treatment. This includes evaluating changes in symptoms and any side effects experienced.

    Participants are assessed using various scales, such as the Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale, to measure the effectiveness of the treatment.

  4. Step 4

    Long-term evaluation

    The study aims to evaluate the long-term efficacy of riliprubart. Participants continue to be monitored for an extended period to assess the sustainability of the treatment effects.

    This phase involves periodic assessments and may include additional tests to gather comprehensive data on the treatment's impact over time.

  5. Step 5

    Completion of study

    Upon completion of the study, participants undergo a final evaluation to document the overall outcomes and any lasting effects of the treatment.

    Participants are provided with information regarding the study results and any further steps, if applicable.

Who can join the trial?

12 criteria

  • Participant must have **CIDP** (Chronic Inflammatory Demyelinating Polyneuropathy) or possible CIDP, based on specific guidelines.
  • All participants must agree to use **contraception methods** during and after the study as required.
  • Body weight must be between 35 kg (77 lbs) and 154 kg (340 lbs) at the start of the study.
  • Male participants must agree to not donate or preserve sperm and either remain abstinent or use a condom plus another effective contraceptive method during the study and for at least 55 weeks after the last dose of study medication.
  • Female participants must not be pregnant or breastfeeding and must agree to use a highly effective contraceptive method during the study and for at least 55 weeks after the last dose of study medication.
  • Participant must have either typical CIDP or specific variants like motor CIDP or multifocal CIDP, confirmed by a committee.
  • Participant must not respond well to either **immunoglobulin therapy** or **corticosteroid therapy**. This means they have not shown significant improvement after specific treatments.
  • Participant must have an **INCAT score** (a measure of disability) between 2 and 9, with a score of 2 coming only from leg disability.
  • Any allowed **immunosuppressant drugs** must have been taken for at least 6 months at a stable dose for at least 3 months before the study starts.
  • Participant may be taking low-dose oral corticosteroids, but only if the dose has been stable for at least 3 months before the study starts.
  • Participant must have active disease, shown by a **CIDP disease activity score** of 2 or more points at the start of the study.
  • Participant must have received vaccinations against certain bacterial infections within 5 years before the study or at least 14 days before the first dose of the study medication.

Who cannot join the trial?

10 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 or are planning to have one during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to the study medication or similar drugs.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have a history of substance abuse or alcohol dependency.
  • Patients who have certain mental health conditions that might affect their ability to participate.
  • Patients who are taking medications that might interfere with the study drug.
  • Patients who have an unstable medical condition that requires frequent changes in treatment.
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Investigated drugs

Riliprubart is a medication being studied for its effectiveness in treating refractory chronic inflammatory demyelinating polyneuropathy, a condition that affects the nerves and can cause weakness and numbness. The trial aims to assess how well riliprubart works in improving the symptoms of this condition, using a specific scale to measure changes in disability. The study also looks at the long-term benefits of using riliprubart for this condition.

What is already known about the treatment

Riliprubart – Riliprubart is administered orally and is currently being studied in a Phase 3 clinical trial for its effectiveness and safety in treating chronic inflammatory demyelinating polyneuropathy (CIDP). This medication is not yet widely recognized in medical literature as it is still under investigation. It is primarily indicated for patients with refractory CIDP, a condition characterized by progressive weakness and impaired sensory function in the legs and arms. Riliprubart works by modulating the immune response to reduce inflammation and prevent further nerve damage. It is classified as an immunomodulatory agent.

Investigated diseases

Chronic Inflammatory Demyelinating Polyneuropathy – 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, due to inflammation. The disease typically progresses slowly, with symptoms that may fluctuate over time, including numbness, tingling, and muscle weakness. As the condition advances, individuals may experience difficulty with coordination and balance. The progression can vary greatly among individuals, with some experiencing periods of improvement and others having a steady decline. It is considered a rare disease and can significantly impact daily activities and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506503-26-00Protocol codeEFC17236Estimated enrolment200 patientsSponsorSanofi-Aventis Recherche & Developpement

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