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Riliprubart

Riliprubart is an innovative drug currently being studied in clinical trials for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). These trials aim to evaluate the efficacy and safety of Riliprubart compared to placebo and standard treatments like intravenous immunoglobulin (IVIg) in adults with CIDP, including those who have not responded well to conventional therapies. The studies span up to 109 weeks and involve various assessments to measure the drug’s impact on disability, strength, and quality of life in CIDP patients.

Table of Contents

What is Riliprubart?

Riliprubart, also known by its research name SAR445088, is a new medication currently being studied for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). It is an innovative drug that shows promise in helping patients who have not responded well to standard treatments or who are currently relying on regular intravenous immunoglobulin (IVIg) therapy[1][2].

What Condition Does Riliprubart Treat?

Riliprubart is being developed to treat Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a rare neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. It occurs when the body’s immune system mistakenly attacks the protective covering of nerves (myelin), leading to nerve damage and dysfunction[1][2].

How is Riliprubart Administered?

Riliprubart can be administered in two ways:

  1. Intravenous (IV) Infusion: The medication is given directly into a vein through an IV line.
  2. Subcutaneous (SC) Injection: The medication is injected under the skin.

The specific method of administration may depend on the phase of the clinical trial and the individual patient’s needs[1][2].

Ongoing Clinical Trials

Riliprubart is currently being studied in two major Phase 3 clinical trials:

  1. Trial for Refractory CIDP: This study is testing Riliprubart in patients whose CIDP has not responded well to standard treatments. It compares Riliprubart to a placebo (a substance with no active medication) over 24 weeks, followed by an open-label extension where all participants receive Riliprubart[1].
  2. Trial Comparing Riliprubart to IVIg: This study is comparing Riliprubart to the standard treatment of intravenous immunoglobulin (IVIg) in patients who are currently receiving IVIg maintenance therapy. It aims to determine if Riliprubart can be as effective as or better than IVIg[2].

Both trials are expected to last up to 109 weeks, including screening, treatment, and follow-up periods[1][2].

Expected Benefits

The researchers are hoping to see several improvements in patients taking Riliprubart:

  • Reduced disability: Measured by a decrease in the INCAT (Inflammatory Neuropathy Cause and Treatment) disability score[1][2].
  • Improved overall function: Assessed using the Inflammatory Rasch-built Overall Disability Scale (I-RODS)[1][2].
  • Increased muscle strength: Measured by grip strength and the Medical Research Council Sum Score (MRC-SS)[1][2].
  • Reduced fatigue: Evaluated using the Rasch-built modified fatigue severity scale (RT-FSS)[1][2].
  • Improved quality of life: Assessed with the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L)[1][2].

Safety and Side Effects

As with any new medication, the safety of Riliprubart is being closely monitored during the clinical trials. The researchers are tracking:

  • Treatment-emergent adverse events (TEAEs): Any new medical problems or worsening of existing problems that occur after starting the treatment.
  • Serious adverse events (SAEs): Any severe or life-threatening reactions to the medication.
  • Adverse events of special interest (AESIs): Specific side effects that the researchers are particularly watching for based on the medication’s mechanism of action.
  • Development of anti-drug antibodies (ADA): The body’s immune response to the medication, which could potentially reduce its effectiveness[1][2].

The full safety profile of Riliprubart will be better understood once the clinical trials are completed.

Comparison with Standard Treatment

One of the ongoing trials is directly comparing Riliprubart to intravenous immunoglobulin (IVIg), which is currently the standard treatment for many CIDP patients. This study aims to determine if Riliprubart can be as effective as or potentially more effective than IVIg. Some potential advantages of Riliprubart over IVIg could include:

  • Longer-lasting effects, potentially reducing the frequency of treatments
  • The option for subcutaneous administration, which could be more convenient for some patients
  • Potentially fewer side effects or a different side effect profile compared to IVIg

However, these potential benefits are still being investigated and will be confirmed only after the completion of the clinical trials[2].

Aspect Details
Drug Name Riliprubart (also known as SAR445088)
Condition Studied Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Administration Methods Intravenous (IV) infusion or Subcutaneous (SC) injection
Study Duration Up to 109 weeks (including screening, treatment, and follow-up)
Primary Outcome Measure Decrease of ≥1 point in adjusted INCAT disability score
Comparators Placebo and Intravenous Immunoglobulin (IVIg)
Secondary Outcome Measures Changes in I-RODS, grip strength, MRC-SS, quality of life (EQ-5D-5L), fatigue (RT-FSS)
Safety Monitoring Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs)
Additional Assessments Development of anti-drug antibodies (ADA)

FAQ

  • What is Riliprubart? Riliprubart is a new drug being tested for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). It's administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.
  • How long do the clinical trials for Riliprubart last? The clinical trials for Riliprubart can last up to 109 weeks (about 2 years). This includes screening, treatment phases, and follow-up periods.
  • What is the main goal of these clinical trials? The main goal is to evaluate how well Riliprubart works compared to placebo or standard treatments like intravenous immunoglobulin (IVIg) in people with CIDP, including those who haven't responded well to usual treatments.
  • How do researchers measure if Riliprubart is working? Researchers use various measures, including the INCAT disability score, grip strength, and quality of life assessments. A positive response is often defined as a decrease of at least 1 point in the adjusted INCAT disability score.
  • Are there any side effects being monitored in these trials? Yes, the trials are monitoring for treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs). They're also checking for the development of antibodies against Riliprubart.

Ongoing Clinical Trials on Riliprubart

  • Study on Long-term Safety and Efficacy of Riliprubart for Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

    Recruiting

    1 1 1
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark France Germany +8

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

    Recruiting

    1 1
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark France Germany +7

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

    Recruiting

    1 1 1
    Investigated drugs:
    Belgium Czechia Denmark France Germany Greece +7

  • Long-Term Safety Study of Riliprubart in Patients with Cold Agglutinin Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy The Netherlands

  • Study on Riliprubart for Preventing and Treating Antibody-Mediated Rejection in Adult Kidney Transplant Patients

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Spain Sweden

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

    Not recruiting

    1 1 1
    Investigated drugs:
    France Germany Italy The Netherlands Poland Spain

Glossary

  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): A rare neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms, caused by damage to the myelin sheath of peripheral nerves.
  • Riliprubart: An investigational drug being studied for the treatment of CIDP, also known as SAR445088.
  • Intravenous Immunoglobulin (IVIg): A treatment made from donated blood that contains healthy antibodies. It's commonly used to treat various immune and neurological disorders, including CIDP.
  • INCAT disability score: Inflammatory Neuropathy Cause and Treatment disability score, a measure used to assess the level of disability in patients with inflammatory neuropathies like CIDP.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • Double-blind study: A type of clinical trial where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo.
  • Open-label extension: A phase of a clinical trial where all participants receive the active treatment, and both researchers and participants know what's being administered.
  • Refractory: In medical terms, it refers to a condition that does not respond to standard treatments.
  • Rasch-built Overall Disability Scale (I-RODS): A scale used to measure disability in patients with immune-mediated peripheral neuropathies.
  • Medical Research Council Sum Score (MRC-SS): A system for grading muscle strength in patients with neuromuscular conditions.
  • EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L): A standardized instrument used to measure health-related quality of life.
  • Rasch-built modified fatigue severity scale (RT-FSS): A scale used to assess fatigue in patients with immune-mediated polyneuropathies.
  • Anti-drug antibodies (ADA): Antibodies that the body produces against a therapeutic drug, which can potentially reduce the drug's effectiveness.

References

  1. https://clinicaltrials.gov/study/NCT06290128
  2. https://clinicaltrials.gov/study/NCT06290141