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Study comparing empasiprubart versus intravenous immunoglobulin for treating adults with multifocal motor neuropathy

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What is this trial about?

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

This study focuses on adults with Multifocal Motor Neuropathy, a rare neurological condition that affects motor nerves and causes progressive muscle weakness. The research compares two treatments: a new medication called empasiprubart and standard therapy with intravenous immunoglobulin (a treatment made from donated blood plasma that contains antibodies). The study will also use placebo solutions for comparison purposes.

The main purpose of this research is to determine if empasiprubart is effective at improving muscle strength compared to intravenous immunoglobulin in people with Multifocal Motor Neuropathy. Both medications will be given through intravenous infusion, which means they are administered directly into a vein.

The study is divided into two parts. During the treatment period, participants will receive either empasiprubart or intravenous immunoglobulin along with their matching placebos. Throughout the study, doctors will measure changes in muscle strength and other aspects of the condition. The research team will also monitor the safety of the treatments and collect information about how well participants feel and function in their daily activities.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial phase preparation

    Before starting treatment, you will receive vaccinations against bacterial infections (N. meningitidis and S. pneumoniae) if you haven't had them in the past 5 years

    The vaccination must be completed at least 14 days before starting the study medication

  2. Step 2

    Treatment period - Part A

    The study will compare two treatments: empasiprubart and intravenous immunoglobulin (IVIg)

    You will receive treatment through intravenous infusion (medication given directly into a vein)

    The treatment period lasts 24 weeks

    Your muscle strength will be measured regularly, with special attention to hand strength

    Various assessments will be performed, including tests of hand function and daily activities

    Blood samples will be taken to monitor medication levels and immune system response

  3. Step 3

    Monitoring and assessments

    Regular checks of vital signs and heart activity (ECG)

    Laboratory tests to monitor your health status

    Assessment of fatigue levels and quality of life

    Evaluation of hand function using specific tests

    Regular monitoring of any side effects or reactions to the treatment

  4. Step 4

    Extended observation - Part B

    Continued monitoring of muscle strength and hand function

    Ongoing assessment of daily activities and quality of life

    Regular blood tests to check medication levels

    Continued monitoring of side effects and safety

Who can join the trial?

7 criteria

  • Must be at least 18 years old and able to legally consent to participate in clinical studies
  • Must have a confirmed diagnosis of Multifocal Motor Neuropathy (MMN), either definite or probable, according to established medical guidelines
  • Must have shown positive response to IVIg treatment (intravenous immunoglobulin - a treatment given through a vein) within the past 5 years
  • Must currently be receiving IVIg treatment every 2, 3, 4, or 5 weeks, with a dose between 0.4 to 2.0 grams per kilogram of body weight per treatment cycle
  • Must be on a stable IVIg treatment plan for at least 8 weeks before screening (or 10 weeks for those receiving treatment every 5 weeks), with no major changes in frequency or dose
  • Must receive a minimum weekly IVIg dose of at least 0.125 grams per kilogram of body weight
  • Must either have received vaccines against certain bacteria (N. meningitidis and S. pneumoniae) within the past 5 years, or be willing to get vaccinated at least 14 days before starting the study medication

Who cannot join the trial?

15 criteria

  • History of severe allergic reactions to immunoglobulin treatments (antibody-based medications given through IV)
  • Presence of other neurological conditions that could affect muscle strength assessment
  • Active infections or severe illnesses that could interfere with study participation
  • Previous treatment with experimental medications within 3 months before the study
  • Pregnancy or breastfeeding
  • Significant kidney or liver disease
  • History of blood clotting disorders
  • Uncontrolled high blood pressure
  • Recent surgery within the past 3 months
  • Current participation in other clinical trials
  • Known immunodeficiency conditions (weakened immune system)
  • History of cancer within the past 5 years
  • Severe mental health conditions that could affect ability to follow study procedures
  • Alcohol or drug abuse within the past year
  • Unable to provide informed consent
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Investigated drugs

  • Empasiprubart

    is an investigational medication being studied for treating multifocal motor neuropathy, a rare neurological condition that affects muscle strength. This medication is being developed as a potential alternative to current treatments.

  • Intravenous Immunoglobulin (IVIg)

    is a treatment made from donated blood plasma that contains healthy antibodies. It is given through a vein and is currently used as a standard treatment for multifocal motor neuropathy. IVIg helps reduce inflammation and supports the immune system to improve muscle strength in patients with this condition.

What is already known about the treatment

  • Empasiprubart

    An investigational medication currently being studied in Phase 3 clinical trials for the treatment of Multifocal Motor Neuropathy (MMN), a rare neurological disorder. The drug is being evaluated as a potential alternative to traditional Intravenous Immunoglobulin (IVIg) therapy, with the primary goal of improving muscle strength in adult patients. While the specific mechanism of action and administration route are not fully detailed in the available data, this experimental treatment represents a new therapeutic approach in the field of autoimmune neurological disorders.

  • Intravenous Immunoglobulin (IVIg)

    A well-established treatment administered directly into the bloodstream, containing concentrated antibodies collected from thousands of blood donors. It works by modulating the immune system and is currently considered the standard therapy for Multifocal Motor Neuropathy, helping to improve muscle strength and function in affected patients. This medication belongs to the class of immune globulin therapies and acts by providing passive immunity while regulating inflammatory and immune responses in the body.

Investigated diseases

Multifocal Motor Neuropathy - A rare neurological disorder that affects multiple motor nerves in the body. The condition causes progressive muscle weakness, primarily affecting the arms and hands, though it can also impact the legs. The weakness typically begins on one side of the body and gradually spreads to affect multiple areas. The disease specifically targets motor nerves while leaving sensory nerves intact, which distinguishes it from other neurological conditions. Muscle weakness is often accompanied by muscle cramping and uncontrolled twitching.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516473-72-00Protocol codeARGX-117-2302Estimated enrolment163 patientsSponsorArgenx

sourced from the EU Clinical Trials Register and site verification

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