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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Multifocal Motor Neuropathy (MMN)

In brief

This trial is an extension of the antecedent trial ARGX-117-2002. It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ARGX-117 Intravenously (IV) in adults with Multifocal Motor Neuropathy (MMN). The trial will include a double-blinded rollover treatment period (DTP), an open-label treatment period (OTP), and a safety follow-up period.

Key facts

Study ID

NCT05405361

Run by

argenx

People needed

51

Starts

2023-01-18

Expected to finish

2029-09-30

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capable of providing signed informed consent and complying with protocol requirements. Participants must be able to read and write.
• Must have completed the double-blinded treatment period of the ARGX-117-2002 trial and considered to be eligible for treatment with ARGX-117.

You may not qualify if…

• Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection.
• Clinical evidence of other significant serious diseases, have had a recent major surgery, 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.
• Currently participating in another interventional clinical study.
• Pregnant or lactating or intend to become pregnant during the trial or within 15 months after last dose of the study drug.

Where it is running

• HonorHealth Neurology — Scottsdale, Arizona, United States
• NorthShore University HealthSystem — Glenview, Illinois, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania - Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
• Austin Neuromuscular Center — Austin, Texas, United States
• Medizinische Universitat Wien (Medical University of Vienna) — Vienna, Austria
• AZ Sint-Lucas — Ghent, Belgium
• University Health Network — Toronto, Canada
• CHU Bordeaux - Groupe Hospitalier Pellegrin — Bordeaux, France
• Hôpital Roger Salengro (CHU de Lille) — Lille, France
• CHU de Nice — Nice, France
• Hôpital de la Pitié Salpétrière — Paris, France
• Universitätsklinikum Essen — Essen, Germany
• Universitatsmedizin Gottingen (UMG) Georg-August-Universitaet — Göttingen, Germany
• IRCCS Ospedale San Raffaele S.r.l. — Milan, Italy
• Azienda Ospedaliero Universitaria Pisana — Pisa, Italy
• Azienda Ospedaliera Sant' Andrea — Rome, Italy
• IRCCS Humanitas Research Hospital — Rozzano, Italy
• Universitair Medisch Centrum Utrecht — Utrecht, Netherlands
• Michalski i Partnerzy Lekarze Spolka Partnerska — Krakow, Poland
• Warszawski Uniwersytet Medyczny — Warsaw, Poland
• Hospital Universitario Vall d'Hebron — Barcelona, Spain
• Hospital de La Santa Creu i Sant Pau — Barcelona, Spain
• Hospital Universitari i Politecnic La Fe de Valencia — Valencia, Spain

Full record on ClinicalTrials.gov

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