What side effects are associated with this type of intervention?

Common treatments for Multifocal Motor Neuropathy (MMN) that modulate the immune system, such as intravenous immunoglobulin (IVIg), can have side effects including headache, fever, chills, fatigue, nausea, and muscle aches. More serious but less common side effects may include thromboembolic events, renal dysfunction, and aseptic meningitis. Other immunomodulatory therapies may also cause immunosuppression, increasing the risk of infections. Patients should discuss these potential side effects with their healthcare provider to weigh the benefits and risks of treatment.

What prior FDA approvals exist?

The primary FDA-approved treatment for Multifocal Motor Neuropathy (MMN) is intravenous immunoglobulin (IVIg), which works by modulating the immune system to reduce inflammation and autoimmunity. IVIg has been the mainstay of treatment for MMN, providing significant improvement in muscle strength and function. Other immunomodulatory treatments, such as rituximab, have been explored in clinical trials but are not yet FDA-approved specifically for MMN. These treatments, like ARGX-117, aim to target the immune system to alleviate the symptoms of MMN.

What other types of research exist?

Promising novel alternatives to ARGX-117 for MMN patients include: 1) Eculizumab, a monoclonal antibody that inhibits complement-mediated damage, showing efficacy in various autoimmune conditions. 2) Rituximab, an anti-CD20 monoclonal antibody, effective in reducing B-cell mediated autoimmunity. 3) Mycophenolate mofetil (MMF), an immunosuppressant that has shown efficacy in several autoimmune disorders. These treatments target different aspects of the immune system and have potential for managing MMN.

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Monoclonal Antibodies

ARGX-117 for Multifocal Motor Neuropathy (ARDA Trial)

Phase 2

Waitlist Available

Research Sponsored by argenx

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Summary

This trial is testing ARGX-117, a new treatment, in people with a nerve condition called MMN who are already using IVIg. The goal is to see if ARGX-117 can better manage their nerve function.

Who is the study for?

Adults with Multifocal Motor Neuropathy (MMN) who are stable on IVIg treatment can join this trial. They must be at least 18, have been vaccinated against certain infections, and use approved contraception methods. People with severe psychiatric issues, other serious diseases, recent major surgery, drug abuse history or certain medication use in the last 3 months cannot participate.

What is being tested?

The trial is testing two different doses of a new drug called ARGX-117 compared to a placebo in people with MMN. It's designed to see if ARGX-117 is safe and works well when added to their regular IVIg therapy. Participants will be randomly assigned to one of the groups without knowing which one they're in.

What are the potential side effects?

Possible side effects from ARGX-117 may include reactions related to the immune system since it targets specific parts of it. The exact side effects aren't listed but could resemble those seen with similar treatments like infusion reactions or increased risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in GS (grip strength)

Percent change from baseline in GS (grip strength)

Values baseline in GS (grip strength)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ARGX-117Experimental Treatment1 Intervention

Intravenous administration of ARGX-117

Group II: PlaceboPlacebo Group1 Intervention

Intravenous administration of placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ARGX-117

2020

Completed Phase 2

~170

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multifocal Motor Neuropathy (MMN) work by modulating the immune system to reduce inflammation and autoimmunity. Intravenous immunoglobulin (IVIg) provides antibodies that neutralize harmful autoantibodies, while corticosteroids suppress overall immune activity. These mechanisms are essential for MMN patients as they help prevent further nerve damage and improve muscle strength and function, thereby enhancing the quality of life.