Not recruitingRare disease

Study on Long-term Safety and Effects of ARGX-117 for Adults with Multifocal Motor Neuropathy

Verified siteInvestigational

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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 effects of a treatment called ARGX-117 in adults with a condition known as Multifocal Motor Neuropathy (MMN). MMN is a rare disorder that affects the nerves, leading to muscle weakness, primarily in the arms and hands. The treatment being tested, ARGX-117, is a type of medication known as a monoclonal antibody, which is a protein designed to target specific parts of the immune system. In this study, ARGX-117 is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate the long-term safety and tolerability of ARGX-117 in people with MMN. Participants in the study will receive either the ARGX-117 treatment or a placebo. The study will monitor various aspects of health, including any side effects, changes in muscle strength, and overall well-being over time. Participants will have regular visits to assess their condition and the effects of the treatment.

This study is an extension of a previous trial, meaning it continues to follow participants who have already been involved in earlier research with ARGX-117. The trial aims to gather more information on how the treatment works over a longer period and to ensure it is safe for continued use. The study will help researchers understand the potential benefits and risks of using ARGX-117 for treating MMN, contributing to the development of effective therapies for this condition.

The research process

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

Step 1
Joining the trial
Upon joining the trial, the participant must have completed the previous ARGX-117-2002 trial and be eligible for continued treatment with ARGX-117.
The participant must agree to use contraceptive measures as required by local regulations.
Step 2
Treatment administration
The participant will receive ARGX-117, which is a concentrate for solution for infusion, administered intravenously.
The specific dosage and frequency of administration will be determined by the trial protocol.
Step 3
Monitoring and assessments
Throughout the trial, safety outcomes will be monitored through adverse event (AE) assessments and clinical laboratory tests.
Secondary assessments will include evaluations of muscle strength, grip strength, and overall disability using various scales and tests.
Step 4
Long-term follow-up
The trial aims to evaluate the long-term safety and tolerability of ARGX-117 in adults with multifocal motor neuropathy.
The estimated end date for the trial is August 30, 2027.

Who can join the trial?

5 criteria

Participants must be able to provide signed informed consent, which means they understand the study and agree to participate. They should be able to read and write.
Participants must have completed the previous part of the study called the ARGX-117-2002 trial and be eligible for further treatment with the study medication, ARGX-117.
Participants must agree to use birth control methods that follow local rules:
Male participants must use an acceptable method of birth control until at least 15 months after the last dose of the study medication.
Female participants who can have children must have a negative urine pregnancy test before starting the study medication.

Who cannot join the trial?

3 criteria

Patients who are not adults cannot participate. This means only people who are 18 years or older can join.
Patients who do not have **Multifocal Motor Neuropathy** cannot participate. This is a specific condition affecting the nerves that control muscles.
Patients who are part of a vulnerable population may not be eligible. This refers to groups of people who might need special protection or care.

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Verified sites

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Azienda Ospedaliero-Universitaria Sant Andre
Responsive
Rome, Italy
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Responsive
Warsaw, Poland

Trial locations

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Investigated drugs

ARGX-117 is a medication being studied for its long-term safety and effectiveness in adults with Multifocal Motor Neuropathy (MMN). This trial aims to understand how well patients tolerate the medication over an extended period, as well as its effects on the body, how it is processed by the body, and whether it causes any immune reactions.

Empasiprubart

What is already known about the treatment

ARGX-117 – This medication is administered intravenously and is currently being studied in clinical trials for its long-term safety and effectiveness in treating Multifocal Motor Neuropathy (MMN). It is not yet widely available in medical practice, as it is still under investigation. ARGX-117 is designed to help manage symptoms of MMN, a condition that affects nerve function and muscle strength. The drug works by targeting specific proteins involved in the immune response, potentially reducing inflammation and nerve damage. It is classified as an immunomodulatory agent, which means it helps regulate the immune system's activity.

Investigated diseases

Multifocal Motor Neuropathy – Multifocal Motor Neuropathy (MMN) is a rare neurological disorder characterized by progressive muscle weakness, primarily affecting the arms and hands. It is caused by damage to the peripheral nerves, which are responsible for transmitting signals from the brain to the muscles. The disease typically begins with weakness in one hand and may gradually spread to other parts of the body. Unlike other neuropathies, MMN does not usually cause sensory loss or pain. Over time, the weakness can lead to difficulties with tasks requiring fine motor skills, such as writing or buttoning a shirt. The progression of the disease can vary, with some individuals experiencing periods of stability and others facing continuous decline in muscle strength.