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

Verified siteInvestigationalNo placebo
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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 the long-term safety and tolerability of a treatment called Batoclimab in adults with a condition known as Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a neurological disorder that causes progressive weakness and impaired sensory function in the legs and arms. The treatment being tested, Batoclimab, is administered as a solution for injection under the skin.

The purpose of this study is to evaluate how safe and well-tolerated Batoclimab is over an extended period. Participants in the study will receive regular injections of Batoclimab and will be monitored for any side effects or changes in their condition. The study aims to gather information on how participants respond to the treatment over time.

Participants will be involved in the study for up to 52 weeks, during which they will receive Batoclimab injections and attend regular check-ups to assess their health and any potential side effects. The study will help determine if Batoclimab is a safe and effective long-term treatment option for people with CIDP.

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

    Joining the study

    Upon joining the study, participants will be required to provide written informed consent. This consent confirms understanding and agreement to comply with all aspects of the study treatment and testing schedule.

    Participants must have completed a previous study, identified as Study IMVT-1401-2401, or be deemed by the investigator to benefit from continued access to the study medication, batoclimab.

  2. Step 2

    Medication administration

    Participants will receive batoclimab, which is a solution for injection administered subcutaneously, meaning it is injected under the skin.

    The frequency and dosage of the medication will be determined by the study protocol and communicated by the study team.

  3. Step 3

    Safety and tolerability assessment

    The main objective of the study is to evaluate the long-term safety and tolerability of batoclimab in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).

    Participants will be monitored for any adverse effects, including treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

  4. Step 4

    Ongoing monitoring

    Participants will undergo regular assessments to monitor changes from baseline in specific health scores, such as the adjusted INCAT score and mean grip strength.

    These assessments will help determine the impact of the medication over time.

  5. Step 5

    Completion of study

    The study is estimated to conclude by November 12, 2027. Participants will continue to receive the study medication and undergo assessments until the study's end date.

    Participants must agree not to participate in another interventional study while receiving treatment in this study.

Who can join the trial?

7 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 of the study treatment.
  • Female participants must agree not to donate eggs during the study and for 90 days after the last dose of the study treatment.
  • 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 the last dose of the study treatment.
  • Male participants must agree not to donate sperm during the study and for 90 days after the last dose of the study treatment.
  • Participants must agree not to join another study that involves treatment while they are in this study.
  • Participants must be willing and able to give written consent to join the study. This means they understand the study and agree to follow all the study rules and schedules. If they choose to receive the study treatment at home, they must be able to do so or have someone help them.

Who cannot join the trial?

8 criteria

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

Batoclimab is a medication being studied for its potential to help people with a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a disorder that affects the nerves, causing weakness and numbness. Batoclimab works by targeting and reducing certain proteins in the body that are thought to play a role in causing the symptoms of CIDP. The goal of using Batoclimab in this study is to see if it can be safely used over a long period and to understand how well people tolerate it while managing their CIDP symptoms.

What is already known about the treatment

Batoclimab – Batoclimab is administered as an injection, typically given under the skin. It is currently being studied in clinical trials to assess its long-term safety and tolerability for treating Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition that affects the nerves. The main therapeutic use of Batoclimab is to help manage symptoms of CIDP. At the molecular level, Batoclimab works by targeting and inhibiting specific proteins involved in the immune response, which can help reduce inflammation and nerve damage. It is classified as an immunomodulatory drug, meaning it helps regulate the immune system.

Investigated diseases

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) – 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 progresses slowly, often over several months, and can lead to significant disability if untreated. Symptoms may include tingling or numbness, muscle weakness, loss of deep tendon reflexes, and fatigue. The course of CIDP can vary, with some individuals experiencing periods of improvement and others having a steady progression of symptoms. It is considered a chronic condition that requires ongoing management.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518364-12-00Protocol codeIMVT-1401-2402Estimated enrolment108 patientsSponsorImmunovant Sciences GmbH

sourced from the EU Clinical Trials Register and site verification

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