Active not recruitingPHASE2INTERVENTIONAL

A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy

This study is a continuation of a previous trial, focusing on a medicine called ARGX-117 for adults with a condition called Multifocal Motor Neuropathy (MMN). The main goal is to understand the long-term safety and how well the medicine works. It also investigates how the body processes the medicine and any immune responses. Participants will have different treatment periods, including times where neither they nor their doctors know if they are getting the study medicine or a dummy treatment, followed by an open-label period where everyone gets the study medicine. Finally, there will be a check-up period after treatment ends.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

argenx

Enrolment target

Start

18 Jan 2023

Estimated completion

30 Sep 2029

Multifocal Motor Neuropathy (MMN)

What is this study about?

This research study is about a medicine called ARGX-117, which is being tested in adults who have a condition called Multifocal Motor Neuropathy (MMN). MMN is a rare, long-term condition that affects your nerves, leading to muscle weakness and wasting, especially in your arms and hands. This particular study is an extension of an earlier study, meaning it's designed to gather more information over a longer period.

The main reasons for doing this study are to find out two key things: how safe the medicine is when used over a longer time, and how well it works to help people with MMN. The researchers will also look at how your body handles the medicine (called pharmacokinetics) and how the medicine affects your body (called pharmacodynamics). They will also check if your body develops any immune reactions to the medicine, which is called immunogenicity.

Taking part in this study means you would receive the study medicine, ARGX-117, directly into your vein (IV). The study will be divided into different phases: some participants might first receive either the active medicine or a 'dummy' treatment (placebo) without knowing which it is, then everyone will receive the active medicine, and finally, there will be a follow-up period to monitor your health after treatment finishes.

Key takeaways

This is a long-term study of a new medicine, ARGX-117, for adults with MMN.
It aims to understand the long-term safety and effectiveness of the medicine.
You must have completed a previous study with ARGX-117 to be eligible.
The medicine is given directly into a vein (IV).
Different treatment phases include 'blinded' and 'open-label' periods.
Your health will be monitored closely throughout the study and during a follow-up period.

Who may be eligible?

To be able to join this study, you first needed to have already completed a previous study for this medicine (ARGX-117-2002). You must also be an adult, aged 18 or older.

There are also some important reasons why you might not be able to join. For example, if you have a serious infection that isn't under control, or if you have other serious health problems that the study doctors think might make it unsafe for you to take part or could interfere with the study results. You also can't be in another clinical study at the same time.

Finally, if you are pregnant, breastfeeding, or planning to become pregnant while in the study or shortly after it ends, you would not be able to join. This is to ensure the safety of the participants and any potential babies.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you already completed the ARGX-117-2002 study?
Are you an adult aged 18 or older?
Do you have good overall health, without serious active infections or other major illnesses?
Are you not currently pregnant, breastfeeding, or planning to become pregnant within 15 months after the study?
Are you not taking part in any other clinical studies that involve new treatments?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part, the study will involve receiving the medicine, ARGX-117, directly into a vein (intravenously). The study has several parts: first, a 'double-blind' period where you might receive either the active medicine or a dummy treatment, and neither you nor your doctor will know which one it is. This is followed by an 'open-label' period where everyone receives the active study medicine. After these treatment periods, there will be a safety follow-up period to check on your health. This means regular visits to the clinic for assessments, which might include health checks, blood tests, and possibly questionnaires about your symptoms. The total duration of your participation will cover these different periods, including the active treatment and the follow-up.

Potential risks and benefits

Taking part in this study might offer a potential benefit of receiving a new medicine that could help manage your MMN over the long term. However, there are also potential risks involved, such as side effects from the medicine, which will be carefully monitored by the study team. Some risks are still unknown, as this is a long-term study of a new treatment. You will be given more detailed information about possible side effects. Remember, joining a clinical study is always voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (27)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

HonorHealth Neurology
Verified postcode
Scottsdale, United States
NorthShore University HealthSystem
Verified postcode
Glenview, United States
University of Minnesota
Verified postcode
Minneapolis, United States
The Cleveland Clinic Foundation
Verified postcode
Cleveland, United States
University of Pennsylvania - Perelman Center for Advanced Medicine
Verified postcode
Philadelphia, United States
Austin Neuromuscular Center
Verified postcode
Austin, United States
Medizinische Universitat Wien (Medical University of Vienna)
Verified postcode
Vienna, Austria
AZ Sint-Lucas
Verified postcode
Ghent, Belgium
University Health Network
Verified postcode
Toronto, Canada
CHU Bordeaux - Groupe Hospitalier Pellegrin
Verified postcode
Bordeaux, France
Hôpital Roger Salengro (CHU de Lille)
Verified postcode
Lille, France
CHU de Nice
Verified postcode
Nice, France

Common questions

What is Multifocal Motor Neuropathy (MMN)?

MMN is a rare condition that causes slow, progressive muscle weakness, often in the arms and hands, due to problems with the nerves.

What is ARGX-117?

ARGX-117 is the name of the new medicine being tested in this study to see if it can help people with MMN.

What does 'double-blinded' mean?

In a 'double-blinded' part of the study, neither you nor your study doctor knows if you are receiving the real medicine or a dummy treatment (placebo).

How will I receive the study medicine?

The study medicine, ARGX-117, will be given directly into your vein using a drip (intravenously).

Can I stop participating in the study at any time?

Yes, you are free to leave the study at any point without it affecting your medical care.