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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people with Chronic Inflammatory Demyelinating Polyneuropathy, which is a condition where the protective covering of nerves becomes damaged due to long-term inflammation. This damage affects the nerves outside the brain and spinal cord, leading to weakness, numbness, and difficulty with movement. The study will test a treatment called IMVT-1402, which is given as an injection under the skin. Some people in the study will receive IMVT-1402 while others will receive placebo. The purpose of the study is to see if IMVT-1402 is effective in preventing the disease from getting worse compared to placebo.

People taking part in this study will already be receiving treatment for their condition with either steroid medications taken by mouth or immunoglobulin therapy given through a vein or under the skin. During the study, participants will be checked regularly to see if their symptoms worsen or stay stable. The study will look at different measures of how well people can perform daily activities and how strong their muscles are, including grip strength in the dominant hand and overall muscle strength.

The study will last for several years and will involve multiple visits where various assessments will be done. The main focus will be on measuring whether people remain free from worsening of their condition over a period of 24 weeks. Other measurements will include changes in the ability to perform daily tasks, hand grip strength, and overall muscle strength at the same time point.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment period begins

    Your participation in the treatment phase of the study will begin after completing all required assessments.

    You will be randomly assigned to receive either IMVT-1402 or placebo. The placebo looks identical to the actual medication but contains no active substance.

    Neither you nor your doctor will know which treatment you are receiving during the study. This is called a double-blind design and helps ensure accurate results.

  2. Step 2

    Receiving study medication

    You will receive the assigned treatment as a subcutaneous injection, which means the medication is injected under the skin.

    The study medication is IMVT-1402, provided as a solution for injection, or placebo with the same appearance.

    The specific dosage, frequency, and exact schedule of injections will be determined according to the study protocol.

  3. Step 3

    Regular monitoring visits

    Throughout the study, you will attend regular clinic visits for monitoring and assessments.

    During these visits, your condition will be evaluated using several measurement tools.

    The study team will assess your muscle strength, ability to perform daily activities, and any changes in your symptoms.

  4. Step 4

    Assessment of disease relapse

    Your condition will be monitored to determine whether you experience a relapse, which means a worsening of your symptoms.

    This will be measured using the aINCAT score, a tool that evaluates your ability to perform certain physical tasks related to arm and leg function.

    The main goal of the study is to see if the treatment prevents relapse compared to placebo.

  5. Step 5

    Functional assessments

    Your ability to perform daily activities will be measured using the I-RODS scale, which stands for Inflammatory Rasch-built Overall Disability Scale.

    Your grip strength in your dominant hand will be measured to assess hand function.

    Your muscle strength will be evaluated using the MRC-SS, which stands for Medical Research Council Sum Score. This involves testing the strength of various muscle groups.

    These assessments will be performed at the beginning of the study and repeated at Week 24 to measure any changes.

  6. Step 6

    Week 24 evaluation

    At Week 24, a comprehensive evaluation will be conducted.

    All the assessments performed at the beginning of the study will be repeated to measure changes in your condition.

    The results will help determine the effectiveness of the treatment in preventing relapse and improving or maintaining your physical function.

  7. Step 7

    Continuation of background therapy

    During the study, you will continue receiving your current treatment for chronic inflammatory demyelinating polyneuropathy.

    This may include corticosteroids, which are medications that reduce inflammation, or immunoglobulin therapy, which involves receiving antibodies to help regulate your immune system.

    Your background therapy will remain at stable doses throughout the study period.

  8. Step 8

    Study completion

    The treatment and observation period will continue as specified in the study protocol.

    Final assessments will be completed to evaluate the overall results of the treatment.

    Your participation in this phase of the study will conclude after all required evaluations are finished.

Who can join the trial?

4 criteria

  • You must be 18 years of age or older at the time you sign the consent form to join the study
  • You must have been diagnosed with typical CIDP, which is a condition where the protective covering of nerves becomes inflamed and damaged, or with one of these specific types: multifocal CIDP, meaning the nerve damage affects multiple separate areas, or motor CIDP, meaning the nerve damage mainly affects movement, according to the 2021 European Academy of Neurology and Peripheral Nerve Society guidelines
  • You must have had electrodiagnostic tests, which are special tests that measure how well your nerves are working using electrical signals, and these test results must support your CIDP diagnosis according to the European Academy of Neurology and Peripheral Nerve Society guidelines
  • You must currently be receiving and have been receiving for at least 3 months one of the following stable treatments for CIDP: either systemic corticosteroids, which are medications that reduce inflammation throughout the body and can be taken daily, every other day, or in pulse doses, or immunoglobulin therapy, which is a treatment using antibodies given either through a vein called intravenous immunoglobulin or under the skin called subcutaneous immunoglobulin, with or without a low dose of oral corticosteroids

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified in the available study information
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Investigated drugs

IMVT-1402 is an investigational medication being tested in this clinical trial for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a condition that affects the nerves and causes weakness and numbness. This medication is being studied to see if it can help prevent the disease from getting worse or coming back after treatment. In this trial, IMVT-1402 will be compared to a placebo to determine how well it works in keeping patients stable and preventing relapses of their symptoms.

What is already known about the treatment

IMVT-1402 – This is an experimental medication currently being tested in phase 2b clinical trials for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition where the body's immune system attacks the protective covering of nerves, causing weakness and numbness. The study is evaluating whether IMVT-1402 can prevent the disease from getting worse compared to a placebo (inactive treatment), measuring improvement using a scoring system that tracks physical abilities. While the exact way this medication works at the molecular level and its specific form of administration are not detailed in the available trial information, it is being developed as a potential treatment option for adults suffering from this chronic nerve disorder.

Investigated diseases

Chronic Inflammatory Demyelinating Polyneuropathy – This is a rare neurological disorder that affects the peripheral nerves, which are the nerves outside the brain and spinal cord. The condition causes the protective covering of nerves, called myelin, to become damaged due to ongoing inflammation. As the disease progresses, patients experience gradually worsening muscle weakness and loss of sensation, typically affecting both sides of the body. The symptoms often start in the legs and arms, making it difficult to perform everyday tasks like walking, climbing stairs, or gripping objects. The disease typically develops slowly over at least eight weeks, distinguishing it from similar but more rapidly progressing conditions. Many patients experience periods when symptoms worsen, known as relapses, followed by periods of stability or partial improvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517614-14-00Protocol codeIMVT-1402-2401Estimated enrolment162 patientsSponsorImmunovant Sciences GmbH

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