Chronic inflammatory demyelinating polyradiculoneuropathy – Trials in Disease

Go back

Clinical Trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

This article provides an overview of 13 ongoing clinical trials for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a neurological disorder causing progressive weakness and impaired sensory function. These trials are testing various investigational medications administered through different methods, primarily aimed at maintaining clinical response, preventing relapses, and improving disability scores. Trials are being conducted across multiple European countries and include both treatment-naïve and treatment-experienced patients.

Clinical trial locations

Comparison of TAK-881 and HyQvia for adults with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

This study compares two medications containing human normal immunoglobulin: TAK-881 and HyQvia. Both treatments are delivered under the skin through subcutaneous injections.

Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of CIDP by a nerve specialist. They must have shown improvement with previous immunoglobulin treatment and be currently receiving stable treatment with immunoglobulin therapy for at least 12 weeks before screening. The monthly dose should be between 0.4 to 2.4 grams per kilogram of body weight, with treatment intervals of 2-6 weeks. An INCAT disability score between 0 and 7 is required. Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control.

Main exclusion criteria: The study excludes individuals with a history of severe allergic reactions to immunoglobulin treatments, active blood clots or high risk of developing them, severe kidney problems, IgA deficiency with antibodies against IgA, pregnancy or breastfeeding, participation in another trial within 30 days, active infections, blood clots in the past 12 months, significant liver disease, uncontrolled high blood pressure, cancer within the past 5 years (except treated skin cancer), known allergies to study medication components, and inability to comply with study procedures.

Focus and goal: The study evaluates how these medications work in the body when given through subcutaneous injection. Participants will receive treatment for approximately 27 weeks. Blood samples will be collected to measure the levels of medication in the body over time. The main focus is on measuring antibody levels in the blood and assessing neurological symptoms using the INCAT disability score.

Investigational drugs: TAK-881 is an investigational medication administered through subcutaneous injection. HyQvia is an established immune globulin infusion that combines normal human immunoglobulin with recombinant human hyaluronidase, administered subcutaneously to help provide antibodies that protect against infections.

Study of DNTH103 Treatment for Adults with Chronic Inflammatory Demyelinating Polyneuropathy: Comparing Effectiveness with Placebo

This study tests DNTH103, a new medication given as an injection, compared to placebo. The maximum daily dose is 1200 mg, with treatment for up to 172 days.

Main inclusion criteria: Participants must be able to understand and follow study procedures and provide written informed consent. Body weight must be between 40 and 120 kilograms. A confirmed diagnosis of CIDP or possible CIDP is required, specifically typical CIDP or motor/multifocal variants. The CIDP Disease Activity Status score must be 3 or higher during screening. Participants must be neurologically stable with an adjusted INCAT score between 2 and 9. They must meet one of these conditions: currently receiving or previously responded to immunoglobulin treatment, currently receiving or previously responded to corticosteroid treatment, had unsuccessful treatment with standard therapies, or never received treatment. Required vaccinations against certain bacteria must be documented. Male participants must be surgically sterile or agree to use contraception and not donate sperm. Female participants must be unable to bear children or agree to use effective contraception and not donate eggs or attempt to become pregnant.

Main exclusion criteria: Age below 18 or above 65 years, other neurological conditions besides CIDP, current participation in other trials, history of severe allergic reactions to medications, pregnancy or breastfeeding, severe kidney or liver disease, uncontrolled diabetes or high blood pressure, blood clotting disorders, active infections, major surgery within 3 months, cancer or history of cancer in the past 5 years, substance abuse or alcohol dependency, mental health conditions that could interfere, inability to provide informed consent, and use of immunosuppressive medications other than those specified.

Focus and goal: The study involves two main parts. In the first part, all participants receive DNTH103 to check if they respond to treatment. In the second part, participants who showed improvement are randomly assigned to continue receiving either DNTH103 or placebo. The study monitors how long it takes for symptoms to return (relapse) after treatment. Regular assessments measure muscle strength, ability to perform daily activities, grip strength, fatigue levels, and overall quality of life. Blood tests monitor the presence of antibodies against the medication.

Investigational drug: DNTH103 is an investigational medication being studied for preventing relapses in adults with CIDP.

Study on Long-term Safety and Efficacy of Efgartigimod PH20 SC in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This study evaluates the long-term safety and effectiveness of efgartigimod PH20 SC, a medication injected under the skin, in people with CIDP.

Main inclusion criteria: Participants must be able to understand the trial requirements and agree to participate by signing a consent form, including agreeing to share health information related to the research. They must be willing and able to follow trial procedures, including attending required visits. Participants must be either male or female and have one of the following: completed the Week-48 visit of Stage B of a previous trial and be eligible for treatment, experienced worsening during Stage B of a previous trial and be eligible for treatment, been offered participation due to early termination of a previous trial and be eligible, or completed the Week-48 visit of a previous cycle and be eligible to continue. Women of childbearing potential must have a negative pregnancy test before starting and must use an acceptable method of birth control from consent until the last dose.

Main exclusion criteria: Any other serious health conditions that might interfere, pregnancy or breastfeeding, history of allergic reactions to the study medication or similar drugs, current participation in another clinical trial, major surgery within the last 3 months, uncontrolled high blood pressure or significant heart problems, active infections requiring treatment, history of substance abuse or alcohol dependency, live vaccines within the last 4 weeks, and autoimmune diseases that are not stable or controlled.

Focus and goal: The study monitors participants over an extended period to observe any side effects or adverse events. Various health assessments are conducted to track progress, including blood sampling for laboratory abnormalities. Participants complete questionnaires about quality of life, pain levels, treatment satisfaction, and feelings of anxiety or depression. The study also monitors the percentage of patients performing self-administration over time. Upon completion, a final assessment evaluates overall health and treatment effects.

Investigational drug: Efgartigimod PH20 SC combines efgartigimod, which helps reduce harmful antibodies that attack nerves, and recombinant human hyaluronidase PH20, which helps the medication spread more easily under the skin. This combination aims to provide relief from symptoms by targeting the underlying cause of nerve damage.

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

This study evaluates riliprubart, administered as a solution through subcutaneous injections using a pre-filled pen.

Main inclusion criteria: Participants must have CIDP and be currently receiving riliprubart. They 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, following local rules. Participants must be able to give signed informed consent, meaning they understand and agree to follow the study rules and restrictions.

Main exclusion criteria: Patients with immune system diseases cannot participate, meaning if the body’s defense system is not working properly.

Focus and goal: The main goal is to assess the long-term safety and tolerability of riliprubart. The study monitors participants who have completed treatment in previous studies. Regular monitoring includes checking for any adverse events or side effects, as well as conducting laboratory tests, electrocardiograms, and measuring vital signs. Participants are evaluated for improvements such as changes in disability scores, grip strength, and muscle strength. The study continues until July 31, 2029.

Investigational drug: Riliprubart is a medication being studied for its effects on CIDP. It is administered through subcutaneous injection using a pre-filled pen. The study aims to understand if it is safe and well-tolerated when used over a long period and if it can help manage symptoms.

Study on Rituximab for Achieving Remission in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This study explores adding Rituximab to a limited period of IVIg treatment to achieve long-term remission in patients who have not previously received treatment for CIDP.

Main inclusion criteria: For new patients, must meet the EAN/PNS criteria for CIDP and must not have received any treatment yet. For patients already on treatment, must be on a stable dose of IVIg or SCIg for at least 3 months or 4 infusions and must have experienced symptoms returning before the next infusion, a failed attempt to stop treatment, or an increase in dose leading to improvement. Must be between 18 and 80 years old and have a level of disability related to CIDP that requires treatment with IVIg and RTX. Must be able to understand the study and sign a consent form.

Main exclusion criteria: Patients not diagnosed with CIDP cannot participate. Patients younger than 18 or older than 65 are not eligible. Those part of a vulnerable population, such as pregnant women or those unable to give consent, are excluded.

Focus and goal: The study lasts for 26 weeks and aims to see if adding Rituximab can help patients stop needing regular IVIg infusions. The primary endpoint is to achieve remission at 52 weeks after starting rituximab treatment, with follow-up extending to 104 weeks to ensure stability. Throughout the study, participants undergo various tests measuring grip strength, walking ability, and other functional abilities. Blood samples monitor levels of immunoglobulin and other blood components. The study is expected to continue until 2028.

Investigational drugs: Rituximab targets specific cells in the immune system thought to contribute to the disease. It is given through intravenous infusion. IVIg involves infusing antibodies into the bloodstream to help reduce inflammation and improve nerve function.

Study on the Effectiveness and Safety of Nipocalimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This study tests nipocalimab, given as a solution for infusion, to evaluate how effective and safe it is in delaying the return of symptoms in adults with CIDP who initially respond to treatment.

Main inclusion criteria: Must be an adult, 18 years or older. Must have a diagnosis of CIDP according to specific medical guidelines, confirmed by a special committee during the screening process. Must have an INCAT disability score between 2 and 9, with a score of 2 due to leg disability.

Main exclusion criteria: Patients with other serious health conditions that might interfere, current participation in another clinical trial, recent infection or illness that could affect results, pregnancy or breastfeeding, history of allergic reactions to similar medications, inability to follow study procedures or attend scheduled visits, history of substance abuse that could interfere, recent treatments that might affect the study, and patients with CIDP who do not respond to the study medication in the initial stage.

Focus and goal: The study is designed to be double-blind, meaning neither participants nor researchers know who receives the actual treatment or placebo. It involves regular assessments to track progression of symptoms and overall health, including checking muscle strength, grip strength, and other physical abilities. The study takes place over several stages. The primary goal is to determine the proportion of participants who remain free from relapse at Week 36, with assessments of time to first relapse and changes in various clinical scores. The trial is estimated to conclude by July 31, 2030.

Investigational drug: Nipocalimab is administered intravenously. It works by targeting and blocking certain proteins involved in the immune response, which can help reduce inflammation and nerve damage. It is classified as an immunomodulatory agent.

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

This study compares riliprubart against the usual treatment of intravenous immunoglobulin. Riliprubart is administered as a solution for injection, either through a pre-filled pen or vial.

Main inclusion criteria: Must have CIDP or possible CIDP based on specific guidelines. Must be receiving treatment with IVIg 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. Must have active disease, shown by a CIDP disease activity score of 2 or more points. Must have received vaccinations against certain bacterial infections within 5 years or at least 14 days before the first dose. Must weigh between 35 kg and 154 kg. There must be evidence of at least one significant worsening 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. 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. 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. Must have either typical CIDP or specific variants like motor or multifocal CIDP, confirmed by the study committee. Must have shown improvement with IVIg treatment in the past 5 years. Must be on a stable maintenance dosage of IVIg with no significant changes in dosage or frequency for at least 8 weeks. Must have an INCAT score of 2 to 9, confirmed at baseline.

Main exclusion criteria: Patients not diagnosed with CIDP cannot participate. Those not within the specified age range, not part of specific trial groups, not meeting other specific health criteria, or part of a vulnerable population are not eligible.

Focus and goal: The study monitors participants over a period to assess their response, focusing on improvements in condition and any side effects. Throughout the study, participants undergo regular assessments to track changes in symptoms and overall health, including disability using the INCAT disability scale, grip strength, and other health metrics. The study is double-blind, meaning neither the participant nor the study team knows which treatment is being administered. Regular monitoring visits assess effectiveness and safety, with physical examinations, laboratory tests, and assessments of disability and grip strength. Long-term follow-up continues to monitor effects, evaluating long-term efficacy compared to IVIg.

Investigational drugs: Riliprubart is being studied for its effectiveness in treating CIDP. IVIg is a treatment involving giving a mixture of antibodies through a vein, commonly used to treat various immune system disorders, including CIDP.

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

This study tests riliprubart for people with CIDP for whom usual treatments do not work. Riliprubart is given as a solution for injection.

Main inclusion criteria: Must have CIDP or possible CIDP based on specific guidelines. All participants must agree to use contraception methods during and after the study. Body weight must be between 35 kg and 154 kg. 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. 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. Must have either typical CIDP or specific variants like motor or multifocal CIDP, confirmed by a committee. Must not respond well to either immunoglobulin therapy or corticosteroid therapy, meaning they have not shown significant improvement after specific treatments. Must have an INCAT score 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. May be taking low-dose oral corticosteroids only if the dose has been stable for at least 3 months. Must have active disease, shown by a CIDP disease activity score of 2 or more points. Must have received vaccinations against certain bacterial infections within 5 years or at least 14 days before the first dose.

Main exclusion criteria: Patients with other serious health conditions that might interfere, current participation in another clinical trial, recent major surgery or planning one during the study, pregnancy or breastfeeding, history of allergic reactions to the study medication or similar drugs, inability to follow study procedures or attend required visits, history of substance abuse or alcohol dependency, certain mental health conditions that might affect ability to participate, medications that might interfere with the study drug, and unstable medical condition requiring frequent changes in treatment.

Focus and goal: Participants receive either riliprubart or placebo over a period of time with regular injections and follow-up visits to monitor health and treatment effects. The study uses various measures to evaluate effectiveness, including changes in disability scores and grip strength. An initial assessment confirms eligibility and establishes a baseline. The treatment phase involves intravenous infusion or subcutaneous injection, with dosage and frequency determined by the study protocol. Regular follow-up visits monitor response to treatment, evaluating changes in symptoms and side effects using scales such as the INCAT disability scale. Long-term evaluation assesses the sustainability of treatment effects with periodic assessments and additional tests. The study aims to determine if riliprubart can provide meaningful improvement for people with CIDP who have not responded to other treatments, continuing until December 31, 2030.

Investigational drug: Riliprubart is being studied for its effectiveness in treating refractory chronic inflammatory demyelinating polyneuropathy. The study aims to assess how well it works in improving symptoms using a specific scale to measure changes in disability and to look at long-term benefits.

Study on the Long-term Safety of Batoclimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This study evaluates the long-term safety and tolerability of Batoclimab, a solution for injection under the skin, in adults with CIDP.

Main inclusion criteria: Participants must have completed a previous study called IMVT-1401-2401. If that study was stopped early for reasons not related to safety, participants who might still benefit from the study drug, in the opinion of the study doctor, can join. Female participants who can have children must agree to use a very effective form of birth control from the time they sign the consent form until 90 days after their last dose and agree not to donate eggs during the study and for 90 days after. Male participants must agree to use one very effective form of birth control with partners who can have children during the study and for 90 days after and agree not to donate sperm during the study and for 90 days after. Participants must agree not to join another study that involves treatment while in this study. Participants must be willing and able to give written consent, understanding the study and agreeing to follow all study rules and schedules. If they choose to receive treatment at home, they must be able to do so or have someone help them.

Main exclusion criteria: Must not have any other serious health conditions that could interfere, should not be pregnant or planning to become pregnant, must not have a history of severe allergic reactions to medications, should not be currently participating in another clinical trial, must not have a history of drug or alcohol abuse within the past year, should not have any infections that require treatment with antibiotics, must not have received any vaccines within 4 weeks before the study starts, and should not have any condition that, in the opinion of the study doctor, makes them unsuitable.

Focus and goal: The study aims to gather information on how participants respond to treatment over time. Participants will be involved in the study for up to 52 weeks, receiving Batoclimab injections and attending regular check-ups to assess health and potential side effects. Upon joining, participants provide written consent and confirm eligibility, including having completed a previous study or being deemed by the investigator to benefit from continued access to batoclimab. The medication is administered subcutaneously, with frequency and dosage determined by the study protocol. The main objective is to evaluate long-term safety and tolerability, monitoring for any adverse effects, including treatment-emergent adverse events and serious adverse events. Participants undergo regular assessments to monitor changes from baseline in specific health scores, such as the adjusted INCAT score and mean grip strength. The study is estimated to conclude by November 12, 2027.

Investigational drug: Batoclimab works by targeting and reducing certain proteins in the body thought to play a role in causing symptoms. The goal is to see if it can be safely used over a long period and to understand how well people tolerate it while managing symptoms.

Study on the Safety and Effects of NVG-2089 for Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This study evaluates NVG-2089, administered as a solution through intravenous infusion, to assess safety and tolerability in individuals diagnosed with CIDP.

Main inclusion criteria: Must be at least 18 years old. Must have been diagnosed with CIDP or possible CIDP according to specific criteria. Must have a specific score on a test called INCAT, which measures disability. This score must be at least 2 for those who have not been treated before, and between 2 and 7 for those who have been treated before. The score of 2 should come from leg disability. For those who have been treated before, there must be evidence of either worsening symptoms when treatment was stopped or reduced, or improvement in symptoms with standard treatment, documented in medical records. Participants who have not been treated before should not have used certain treatments like IVIg, SCIg, corticosteroids, or experimental therapies for CIDP. Participants who have been treated before should be on a stable dose of IVIg or SCIg without worsening of the disease for 8 weeks before the study and must be willing to stop these treatments before starting the study drug. Female participants who can have children must have a negative pregnancy test before starting the study and on the first day, and must use two forms of birth control, including a barrier method, starting 28 days before the study and continuing for 90 days after the last dose, and should not donate eggs during this time (exceptions for those surgically sterile or post-menopausal). Male participants with female partners who can have children must agree to use highly effective barrier contraception during the study and for 90 days after the last dose. Participants must be able to provide informed consent or have a legally authorized representative who can do so.

Main exclusion criteria: Patients who do not have CIDP cannot participate. Those not within the specified age range, not part of the specified clinical trial groups, not male or female, or not considered part of a vulnerable population cannot participate.

Focus and goal: Participants receive NVG-2089 over a period of time, and researchers monitor them to observe side effects or improvements in condition. The study involves regular check-ups and assessments to ensure participant well-being and to gather data on how treatment affects symptoms. Throughout the study, participants are closely observed for changes in health, including adverse reactions to treatment. The study also tracks improvements in symptoms such as muscle strength and overall physical ability. Upon joining, a healthcare professional reviews medical history and conducts a physical examination to ensure study requirements are met. A blood sample is taken to confirm a negative pregnancy test if applicable. The medication is administered directly into the vein, with frequency and dosage determined by the study protocol. Throughout, participants have regular visits to monitor health and treatment effects, including physical examinations, blood tests, and other assessments, and are asked about side effects or changes in condition. After completing the treatment phase, follow-up visits check health status and gather additional information about long-term effects, an essential part to ensure well-being and collect comprehensive data on treatment impact.

Investigational drug: NVG-2089 is administered through intravenous infusion. It works by targeting specific pathways involved in the inflammation and damage of nerve fibers, aiming to reduce symptoms and improve nerve function. It is classified under pharmacological agents that modulate immune responses.

Summary

The 13 ongoing clinical trials for chronic inflammatory demyelinating polyradiculoneuropathy represent a diverse range of investigational approaches to managing this challenging neurological condition. Several notable patterns emerge from these studies. Geographically, trials show broad distribution across Europe, with Germany, Poland, Italy, Spain, and France featuring most prominently, reflecting these countries’ research infrastructure and patient populations. Multiple trials are testing riliprubart (also known as SAR445088), indicating significant pharmaceutical interest in this particular compound across various patient populations—including treatment-naïve, treatment-refractory, and currently treated patients. Similarly, batoclimab appears in two major trials focused on long-term safety and maintenance of clinical response.

The studies employ different therapeutic mechanisms, ranging from traditional immunoglobulin therapies (both subcutaneous and intravenous) to novel immunomodulatory agents. Many trials focus on preventing relapses and maintaining clinical response rather than initial treatment, suggesting a shift toward understanding long-term disease management. Several studies specifically target patients who do not respond well to standard treatments, addressing an important unmet medical need. The trials vary in their administration methods, with some comparing subcutaneous versus intravenous delivery routes, which has important implications for patient convenience and quality of life.

Most studies use similar outcome measures, particularly the INCAT disability score and grip strength assessments, allowing for potential future comparisons across different treatments. The trials are generally designed with long follow-up periods, extending in some cases to 2029 or 2030, reflecting the chronic nature of the condition and the need to understand long-term safety and efficacy. This comprehensive research effort offers hope for improved treatment options for people living with CIDP, addressing both effectiveness and tolerability concerns across diverse patient populations.

Ongoing Clinical Trials on Chronic inflammatory demyelinating polyradiculoneuropathy

  • A Study of IMVT-1402 in Adults with Chronic Inflammatory Demyelinating Polyneuropathy to Prevent Disease Relapse

    Recruiting

    Investigated drugs:
    Austria Belgium Bulgaria Denmark Estonia Finland +13
  • Study of DNTH103 Treatment for Adults with Chronic Inflammatory Demyelinating Polyneuropathy: Comparing Effectiveness with Placebo

    Recruiting

    1 1
    Investigated drugs:
    Belgium Bulgaria Croatia Denmark France Germany +6
  • Study on the Safety and Effects of NVG-2089 for Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

    Not recruiting

    1 1
    Investigated drugs:
    Belgium Bulgaria France Italy Poland Spain
  • Study on the Long-term Safety of Batoclimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

    Not recruiting

    1 1
    Investigated drugs:
    Belgium Bulgaria Denmark Germany Greece Italy +4
  • Study on Batoclimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

    Not recruiting

    Investigated drugs:
    Belgium Bulgaria Denmark Finland Germany Greece +8
  • 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
  • Study Comparing Subcutaneous and Intravenous Human Normal Immunoglobulin for New Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Denmark