Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on Batoclimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 testing a treatment called Batoclimab, which is a solution for injection. Batoclimab is also known by its code name IMVT-1401. The trial will compare the effects of Batoclimab to a placebo in adult participants who have active CIDP.

The purpose of the study is to evaluate how effective Batoclimab is in maintaining a clinical response in people with CIDP who are already receiving treatments like immune globulin or plasma exchange. Participants will be randomly assigned to receive either Batoclimab or a placebo. The study will be conducted over a period of time, and participants will receive regular injections. The trial aims to see if Batoclimab can help prevent relapses, which are periods when symptoms worsen.

Throughout the study, participants will be monitored to assess their response to the treatment. This will include checking for any changes in their condition and measuring their strength and ability to perform daily activities. The study will help determine if Batoclimab is a safe and effective 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, participation is confirmed for individuals aged 18 or older who have been diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) or its variants.

    Eligibility is based on specific clinical criteria and diagnostic tests that support the diagnosis of CIDP.

  2. Step 2

    Treatment administration

    Participants receive either the medication batoclimab or a placebo. The placebo is identical in appearance but contains no active substance.

    The medication is administered as a subcutaneous injection, which means it is injected under the skin.

  3. Step 3

    Monitoring and assessment

    Throughout the study, participants are monitored to evaluate the effectiveness of the treatment in maintaining clinical response.

    Assessments include measuring changes in the adjusted inflammatory neuropathy cause and treatment (Adj INCAT) score, grip strength, and other disability scales.

  4. Step 4

    Evaluation of outcomes

    The primary goal is to determine the proportion of participants who remain free from relapse at Week 36.

    Secondary outcomes include the time to first relapse and changes in various clinical scores from the baseline to Week 36.

  5. Step 5

    Completion of the study

    The study is expected to conclude by January 31, 2027.

    Participants' health and response to the treatment are evaluated at the end of the study period.

Who can join the trial?

16 criteria

  • You must be **18 years or older** at the time of the Screening Visit.
  • You should have been diagnosed with **Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)**, which is a condition affecting the nerves, or one of its variants like multifocal, focal, or motor CIDP.
  • For typical CIDP, you should have:
    • Muscle weakness that is getting worse or comes and goes, affecting both sides of the body, and involves both the upper and lower limbs.
    • Symptoms that have developed over at least **8 weeks**.
    • Reduced or absent reflexes in all limbs.
    • For CIDP variants, you should have:
      • Multifocal CIDP: Sensory loss and muscle weakness in different areas, usually more in the upper limbs.
      • Focal CIDP: Sensory loss and muscle weakness in only one limb.
      • Motor CIDP: Only motor symptoms without sensory issues.
      • You need to have test results that support the diagnosis of CIDP, which may include:
        • Tests showing nerve issues that suggest demyelination, which means damage to the protective covering of nerves.
        • Improvement after treatment with immunoglobulin, plasma exchange, or corticosteroids.
        • Imaging tests like ultrasound or MRI showing nerve enlargement.
        • Spinal fluid tests showing high protein levels but normal white blood cell levels.
        • Nerve biopsy showing signs of CIDP like swelling or damage to the nerve covering.
        • For Cohort C, you must have a diagnosis of CIDP with strong evidence from nerve tests.
        • For Cohort D, you must meet the clinical criteria for typical CIDP or one of its variants.
        • There are additional criteria that are detailed in the study protocol.

Who cannot join the trial?

4 criteria

  • Patients who are not currently receiving treatments like immune globulin (IVIg or SCIg) or plasma exchange (PLEX) for **Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)** cannot participate. **Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)** is a condition that affects the nerves, causing weakness and numbness.
  • Patients who are not able to maintain a clinical response, which means their condition is not stable or improving with current treatments, are excluded.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they might have additional health or social challenges, are excluded.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Batoclimab is a medication being studied for its potential to help people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This condition affects the nerves and can cause weakness and numbness. The trial is looking at how well Batoclimab can maintain the clinical response in patients who are already receiving other treatments for CIDP.

What is already known about the treatment

Batoclimab – Batoclimab is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). It is in the experimental phase and not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication for Batoclimab is to help maintain clinical response in patients with CIDP who are already receiving treatments like immune globulin or plasma exchange. At the molecular level, Batoclimab works by targeting and modulating the immune system to reduce inflammation and nerve damage. It is classified pharmacologically as an immunomodulatory agent.

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 typically progresses slowly, with symptoms that may include tingling or numbness, muscle weakness, and loss of reflexes. Over time, these symptoms can lead to difficulties with walking and coordination. CIDP is considered a chronic condition, meaning it can persist for a long time and may require ongoing management. The progression of the disease can vary greatly among individuals, with some experiencing periods of improvement and others having a steady decline.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512646-42-00Protocol codeIMVT-1401-2401Estimated enrolment277 patientsSponsorImmunovant Sciences GmbH

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.