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Study on the Effectiveness and Safety of Riliprubart Compared to Intravenous Immunoglobulin in Patients with Chronic Inflammatory Demyelinating Polyneuropathy

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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 neurological disorder that causes progressive weakness and impaired sensory function in the legs and arms. The study is comparing the effectiveness and safety of a new treatment called riliprubart against the usual treatment, which is intravenous immunoglobulin (IVIg). Riliprubart is administered as a solution for injection, either through a pre-filled pen or vial, and is being tested to see if it can provide better or similar benefits compared to IVIg.

The purpose of the study is to evaluate how well riliprubart works in treating CIDP compared to continuing with IVIg. Participants in the study will receive either riliprubart or IVIg, and some may receive a placebo, which looks like the treatment but does not contain the active substance. The study will monitor participants over a period to assess their response to the treatment, focusing on improvements in their condition and any side effects they may experience.

Throughout the study, participants will undergo regular assessments to track changes in their symptoms and overall health. These assessments will help determine the effectiveness of riliprubart in managing CIDP symptoms and its long-term benefits. The study aims to provide valuable information on whether riliprubart can be a viable alternative to the current standard treatment with IVIg for people living with CIDP.

The research process

The trial runs in 7 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 the participant meets all inclusion criteria.

    The assessment involves reviewing medical history, current treatment regimen, and any previous responses to intravenous immunoglobulin (IVIg) therapy.

  2. Step 2

    Baseline Measurements

    Baseline measurements are taken to establish a starting point for the study. These include assessments of disability using the INCAT disability scale, grip strength, and other relevant health metrics.

    Participants must have a stable maintenance dosage of IVIg prior to this step.

  3. Step 3

    Randomization and Treatment Assignment

    Participants are randomly assigned to receive either riliprubart or continue with IVIg treatment. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

    Riliprubart is administered as a solution for injection, either subcutaneously or intravenously, depending on the specific formulation.

  4. Step 4

    Treatment Administration

    Participants receive their assigned treatment according to the study protocol. Riliprubart is given as a subcutaneous injection or intravenous infusion, while IVIg is continued as per the participant's existing regimen.

    The frequency and dosage of riliprubart are determined by the study protocol and may vary based on individual needs.

  5. Step 5

    Regular Monitoring

    Participants attend regular monitoring visits to assess the effectiveness and safety of the treatment. These visits include physical examinations, laboratory tests, and assessments of disability and grip strength.

    Any side effects or adverse events are recorded and managed according to the study guidelines.

  6. Step 6

    Long-term Follow-up

    Participants continue to be monitored for long-term effects of the treatment. This includes ongoing assessments of disability and quality of life.

    The study aims to evaluate the long-term efficacy of riliprubart compared to IVIg.

  7. Step 7

    Study Completion

    Upon completion of the study period, final assessments are conducted to evaluate the overall outcomes of the treatment.

    Participants may be offered the option to continue treatment under a different protocol if applicable.

Who can join the trial?

14 criteria

  • The participant must have **Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)** or possible CIDP, based on specific guidelines.
  • The participant must be receiving treatment with **IVIg** (a type of therapy using antibodies) within a standard maintenance dosing regimen.
  • Participants receiving IVIg infusions at home are eligible if they switch to a hospital or infusion center setting at least one cycle before the study starts.
  • The participant must have active disease, shown by a **CIDP disease activity score (CDAS)** of 2 or more points at the start of the study.
  • The 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.
  • The participant must weigh between 35 kg and 154 kg (77 to 340 lbs) at the start of the study.
  • There must be evidence of at least one significant worsening of the condition within 2 years, or at least two within 5 years, during periods of reduced or interrupted immunoglobulin therapy.
  • All participants must agree to use contraception during and after the study as required.
  • Male participants must agree not to 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.
  • 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.
  • The participant must have either typical CIDP or specific variants like motor CIDP or multifocal CIDP, confirmed by the study committee.
  • Participants must have shown improvement with IVIg treatment in the past 5 years, as documented by specific clinical measures.
  • The participant must be on a stable maintenance dosage of IVIg, with no significant changes in dosage or frequency for at least 8 weeks before the study starts.
  • The participant must have some level of disability, shown by an **INCAT score** of 2 to 9 at the start of the study, confirmed at baseline.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy cannot participate. This is a condition where the body's immune system attacks the protective covering of the nerves.
  • 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 part of a vulnerable population, meaning those who might need special protection or care, are not eligible.
  • Patients who do not meet other specific health criteria set by the study cannot participate. These criteria ensure the safety and appropriateness of the study for each participant.
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Investigated drugs

  • Riliprubart

    is a medication being studied for its effectiveness in treating chronic inflammatory demyelinating polyneuropathy (CIDP). This condition affects the nerves and can cause weakness and numbness. The trial is examining how well riliprubart works compared to another treatment option.

  • Intravenous Immunoglobulin (IVIg)

    is a treatment that involves giving a mixture of antibodies through a vein. It is commonly used to treat various immune system disorders, including CIDP. In this trial, IVIg is used as a comparison to see how effective riliprubart is in managing the symptoms of CIDP.

What is already known about the treatment

Riliprubart – Riliprubart is administered intravenously and is currently being studied in clinical trials for its effectiveness and safety in treating Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication for riliprubart is to manage symptoms associated with CIDP, a neurological disorder. At the molecular level, riliprubart is believed to modulate immune responses, potentially reducing inflammation and nerve damage. It is classified pharmacologically 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. 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 walking, balance problems, and fatigue. The condition can vary greatly in severity and duration among different individuals. It is considered a rare disease and can affect people of all ages.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508338-33-00Protocol codeEFC18156Estimated enrolment255 patientsSponsorSanofi-Aventis Recherche & Developpement

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