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New antibody drug could reduce infusions for nerve disorder

NCT ID NCT05225675

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests an experimental drug called ARGX-117 in 54 adults with multifocal motor neuropathy (MMN), a condition that causes muscle weakness. Participants receive either ARGX-117 or a placebo by IV, and researchers check if the drug can safely delay the need for standard IVIg treatments. The goal is to see if ARGX-117 can help control the disease with fewer infusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ARGX-117 (an experimental antibody given intravenously)
What this could lead to
If it works, this could point toward a new treatment that reduces the need for regular IVIg infusions in people with multifocal motor neuropathy.
What could go wrong
This is a small, early-phase trial with only 54 participants. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

54 people

The number who actually took part.

Started

Mar 2022

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Capable of giving signed informed consent form (ICF) 2. Male/female at least 18 years of age at the time the informed consent form (ICF) is signed 3. Probable or definite MMN according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) (EFNS/PNS) 2010 guidelines at screening confirmed by the MMN Confirmation Committee (MCC) 4. Receiving a stable IVIg regimen for at least 3 months before screening or recently initiated IVIg treatment 5. IVIg treatment dependency confirmation by the MMN Confirmation Committee (MCC) 6. Immunization with the first meningococcal vaccine and pneumococcal vaccine, and the single Haemophilus influenza type B vaccine must be performed at least 14 days before IMP administration at V1 according to local country-specific immunization schedules. A documented history of vaccination against Neisseria meningitides, Haemophilus influenza type B, and streptococcus pneumonia will be permitted 7. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Exclusion Criteria: 1. Any coexisting condition which may interfere with the outcome assessments 2. Clinical signs or symptoms suggestive for neuropathies other than MMN such as motor neuron disease or other inflammatory neuropathies 3. Severe psychiatric disorder, history of suicide attempt, or current suicidal ideation that in the opinion of the investigator could create undue risk to the participant or could affect adherence with the trial protocol. 4. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection during the screening and/or IVIg monitoring period (IVMP). 5. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of MMN or put the participant at undue risk (eg, SLE). 6. History of malignancy unless resolved by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the IMP. Participants with the following carcinomas will be eligible: 1. Adequately treated basal cell or squamous cell skin cancer 2. Carcinoma in situ of the cervix 3. Carcinoma in situ of the breast 4. Incidental histological finding of prostate cancer 7. Clinical evidence of other significant serious diseases, have had a recent major surgery (including a splenectomy at any time), or who have any other condition in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk 8. Prior/concomitant therapy 1. Cyclophosphamide and/or rituximab and/or eculizumab and/or mycophenolate mofetil within 3 months prior to screening 2. Use of an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of the IMP. 9. Positive serum test at screening for an active viral infection with any of the following conditions: 1. Hepatitis B virus (HBV) that is indicative of an acute or chronic infection 2. Hepatitis C virus (HCV) based on HCV antibody assay 3. HIV based on test results that are associated with an AIDS-defining condition 10. Current or history of (ie, within 12 months of screening) alcohol, drug, or medication abuse 11. Known hypersensitivity reaction to 1 of the components of the IMP or any of its excipients 12. Female participants with a positive serum or urine pregnancy test, lactating females, and those who intend to become pregnant during the trial or within 15 months after last dose of the IMP 13. ALT or AST ≥2 × upper limit of normal and total bilirubin ≥1.5 × upper limit of normal of the central laboratory reference range 14. An estimated glomerular filtration rate of ≤60 mL/min/1.73m2

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Conditions

The condition(s) this trial relates to.

multifocal motor neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multifocal motor neuropathy

Contacts and locations

Locations

  • AZ Sint-Lucas

    Ghent, 9000, Belgium

  • Amsterdam UMC location AMC, Dep of Neurology

    Amsterdam, 1105 AZ, Netherlands

  • Austin Neuromuscular Center

    Austin, Texas, 78756, United States

  • Azienda Ospedaliera Sant'Andrea-UOS Malattie Neuromuscolari

    Rome, 00189, Italy

  • Azienda Ospedaliero Univeritaria Pisana-UOS Neurologia

    Pisa, 56126, Italy

  • CHRU de Lille-Hopital Roger Salengro

    Lille, 59037, France

  • CHU de Bordeaux-Hopital Pellegrin

    Bordeaux, 33076, France

  • CHU de Nice-Hopital Pasteur 2

    Nice, 06001, France

  • California Pacific Medical Center-Forbes Norris MDA/ALS Research Center

    San Francisco, California, 94109, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Genge Partners Montreal

    Québec, H4A 3TA, Canada

  • George Washington Medical Faculty Associates

    Washington D.C., District of Columbia, 20037, United States

  • HonorHealth Research Institute-Neuroscience Research

    Scottsdate, Arizona, 85251, United States

  • HonorHealth Research Institute-Neuroscience Research

    Maitland, Florida, 32751, United States

  • Hopital Pitie Salpetriere

    Paris, 75651, France

  • Hospital Universitari I Politecnic La Fe de Valencia-Servicio Neurologia

    Valencia, 46026, Spain

  • Hospital Universitario Vall d'Herbon

    Barcelona, 08035, Spain

  • Hospital de la Santa Creu I Santa Pau -Sevicio Neurologia

    Barcelona, 08041, Spain

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Instituto Clinico Humanitas (IRCCS)

    Rozzano, 20089, Italy

  • Katholisches Klinikum Bochum

    Bochum, 44791, Germany

  • Medizinische Hochschule Hannover Klinik Fur Neurologie

    Hanover, 30625, Germany

  • Medizinische Universitat Wien Universitatsklienik fur Neurologie

    Vienna, 1090, Austria

  • Michalscy I Partnerzy Lekarze Spolka Partnerska

    Krakow, 31-426, Poland

  • NorthShore University HealthSystem

    Glenview, Illinois, 60026, United States

  • Oxford University Hospitals NHS Trust-Jonh Radcliffe Hospital

    Oxford, OX3 9DU, United Kingdom

  • Perelman Center for Advanced Medicine-University of Penssylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Queen Elisabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Toronto General Hospital

    Toronto, M5G 2C4, Canada

  • Universitatsklinikum Essen

    Essen, 45147, Germany

  • Universitatsklinikum Munster

    Münster, 48419, Germany

  • Universitatsmedzin Gottingen, Klinik fur Neurologie

    Göttingen, 37075, Germany

  • University College London Hospital

    London, ZC1N 3BG, United Kingdom

  • University Medical Centre Utrecht

    Utrecht, 3584 CX, Netherlands

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Minnesota Delware Clinic Research Unit

    Minneapolis, Minnesota, 55414, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • University of South Florida Carol and Frank Morsani Center for Advanced Healthcare

    Tampa, Florida, 33612, United States

  • Uniwersyteckie centrum kliniczne Warszawskiego

    Warsaw, 02-097, Poland

  • West Virginia University Medicine

    Morgantown, West Virginia, 26506, United States

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