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A Study Comparing Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study is looking at chronic inflammatory demyelinating polyneuropathy, which is a condition that affects the nerves outside the brain and spinal cord. In this condition, the protective covering of the nerves becomes damaged due to ongoing inflammation, leading to weakness, numbness, and difficulties with movement and daily activities. The study will compare two different treatments given through a vein. One treatment is empasiprubart, also called ARGX-117, which is a laboratory-made protein designed to block a specific part of the immune system that may contribute to nerve damage. The other treatment is human normal immunoglobulin given through a vein, which is a blood product containing antibodies that is already used to treat this condition. Some participants will receive placebo, which is an inactive substance that looks like the real treatment but contains no active medicine.

The purpose of this study is to show whether empasiprubart works better than human normal immunoglobulin in improving the ability to perform daily activities in adults with this nerve condition. During the study, participants will be randomly assigned to receive either empasiprubart or human normal immunoglobulin through a vein. The study uses a double-dummy design, which means that all participants will receive two infusions to ensure that neither the participants nor the doctors know which treatment is being given. The main assessment will happen at week 24, when doctors will measure changes in functional ability using a scoring system that evaluates arm and leg function.

Throughout the study, various measurements will be taken to assess how well participants can perform daily tasks, their muscle strength, their walking ability, and their overall quality of life. Grip strength will be measured regularly, and participants will complete questionnaires about their disability, fatigue, pain, and general health status. Blood samples will be taken to measure drug levels and to check for any immune responses to the treatment. Safety will be monitored by tracking any unwanted effects, changes in laboratory tests, heart rhythm recordings, and vital signs. The study will also look at how the treatments affect specific proteins in the blood that are involved in the immune response and nerve damage.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    Upon joining the study, you will be randomly assigned to one of two treatment groups. This is done by chance, similar to flipping a coin.

    One group will receive empasiprubart, which is the investigational medication being tested. The other group will receive intravenous immunoglobulin (also called IVIg), which is a standard treatment.

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

  2. Step 2

    Medication administration

    You will receive your assigned medication through an intravenous infusion, which means the medication will be delivered directly into your vein through a needle.

    The infusions will be administered according to a schedule determined by the study protocol.

    Each infusion session will take place at the study site, and the duration of each infusion will be explained to you by the study staff.

  3. Step 3

    Regular assessments during treatment

    Throughout the study, you will undergo regular assessments to measure how your condition is responding to treatment.

    Your functional ability will be measured using the aINCAT score, which assesses your ability to perform daily activities involving your arms and legs.

    Your overall disability will be evaluated using the I-RODS scale, which measures your ability to perform various tasks.

    Your muscle strength will be tested using the MRC Sum Score, which examines the strength of different muscle groups.

    Your grip strength will be measured in both hands, with particular focus on your dominant hand.

    Your mobility will be assessed using the Timed Up and Go test, which measures how long it takes you to stand up, walk a short distance, turn around, walk back, and sit down.

    You will be asked to complete questionnaires about your quality of life, fatigue, pain, and how your condition affects your daily activities and work.

  4. Step 4

    Week 24 evaluation

    At week 24, a comprehensive evaluation will be conducted to assess the effectiveness of your treatment.

    The primary measure will be whether there is a decrease of at least 1 point in your aINCAT score compared to your baseline score at the start of the study.

    Additional measurements will include changes in your disability scale scores, muscle strength, grip strength, and mobility compared to baseline.

  5. Step 5

    Ongoing monitoring

    Throughout the study, your safety will be continuously monitored.

    Blood samples will be taken regularly to check for any changes in laboratory values and to measure medication levels in your blood.

    The study team will monitor for the development of antibodies, which are proteins your immune system might produce in response to the study medication.

    Your heart function will be monitored using electrocardiograms (ECGs), which record the electrical activity of your heart.

    Your vital signs, such as blood pressure, heart rate, and temperature, will be measured regularly.

    Any side effects or health changes you experience will be recorded and assessed by the study team.

  6. Step 6

    Continued participation

    The study will continue beyond week 24, with ongoing treatment and assessments.

    You will continue to receive regular infusions and attend scheduled visits for evaluations.

    Changes in your condition will be tracked over time to understand the long-term effects of the treatment.

  7. Step 7

    Study completion

    The study is expected to continue until May 2030.

    Your individual participation duration will be explained to you by the study team.

    Final assessments will be conducted at the end of your participation to evaluate your overall response to treatment and any long-term effects.

Who can join the trial?

7 criteria

  • You must meet the criteria for CIDP, which is a long-lasting condition where the body's immune system attacks the protective covering of nerves, causing weakness and numbness
  • You must have either typical CIDP or one of these specific forms: motor CIDP (mainly affecting movement), multifocal CIDP (affecting multiple separate nerve areas, also called Lewis-Sumner syndrome), focal CIDP (affecting one specific area), or distal CIDP (affecting the parts of the body farthest from the center, like hands and feet)
  • You must have responded well to IVIg treatment in the past 5 years. IVIg is a medicine made from antibodies given through a vein to help your immune system work better
  • You must be currently receiving IVIg treatment as part of your regular maintenance therapy, with a minimum weekly dose of at least 0.125 grams per kilogram of your body weight
  • You must still have some disability and signs that the disease is still active despite current treatment
  • You can be male or female
  • You must be an adult to participate in this study

Who cannot join the trial?

3 criteria

  • The specific exclusion criteria (reasons why a patient cannot participate in this study) have not been provided in the available information
  • To find out if you can participate in this clinical trial, you will need to speak with the study team who can review the complete list of requirements
  • Generally, clinical trials have rules about who can join based on health conditions, medications being taken, and other medical factors
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Investigated drugs

  • Empasiprubart

    is an investigational medication given through an intravenous infusion, which means it is delivered directly into a vein. This medication is being studied as a potential treatment for chronic inflammatory demyelinating polyneuropathy, a condition that affects the nerves and can cause weakness and numbness. The purpose of testing this medication in the trial is to see if it can help improve a person's ability to perform daily activities and functions.

  • Intravenous Immunoglobulin

    (also known as IVIg) is a medication made from antibodies collected from healthy blood donors. It is given through an intravenous infusion directly into a vein. This medication is already used to treat various conditions where the immune system is not working properly or is attacking the body's own tissues. In this trial, it is being used as a comparison treatment to see how well the investigational medication works against a treatment that is already known to help people with chronic inflammatory demyelinating polyneuropathy.

What is already known about the treatment

Empasiprubart – This medication is administered intravenously (through a vein) and is currently being studied in Phase 3 clinical trials to evaluate its effectiveness and safety. It is being investigated as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that causes nerve damage leading to weakness and loss of sensation in the arms and legs. Empasiprubart works by targeting specific parts of the immune system at the molecular level to reduce inflammation and prevent the immune system from attacking the protective covering of nerves, potentially helping to improve muscle function and mobility in patients with CIDP.

Investigated diseases

Chronic Inflammatory Demyelinating Polyneuropathy – Chronic inflammatory demyelinating polyneuropathy is a neurological disorder that affects the peripheral nerves throughout the body. The condition occurs when the immune system mistakenly attacks the protective covering of nerves called myelin, leading to nerve damage. This damage causes progressive weakness and reduced sensation in the arms and legs. Patients typically experience difficulty with movement, coordination, and performing daily activities due to muscle weakness. The disease develops slowly over time, usually lasting more than eight weeks, which distinguishes it from similar acute conditions. Symptoms may include numbness, tingling, fatigue, and problems with balance and walking.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520097-36-00Protocol codeARGX-117-2401Estimated enrolment218 patientsSponsorArgenx

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).