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

NCT05405361 · tracked via the Priya Life Science Germany tracker

Sponsor

argenx

Phase

Phase 2

Started

2023-01-18

Last updated

2026-03-11

Condition(s) studied

Multifocal Motor Neuropathy (MMN)

Investigational drug(s) / intervention(s)

ARGX-117 →Placebo

ARGX-117: Intravenous administration of ARGX-117

Placebo: Intravenous administration of placebo

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Safety outcomes based on adverse event (AE) monitoring. — Until marketing authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first

Trial sites (27)

Facility	City	Region
HonorHealth Neurology	Scottsdale	Arizona
NorthShore University HealthSystem	Glenview	Illinois
University of Minnesota	Minneapolis	Minnesota
The Cleveland Clinic Foundation	Cleveland	Ohio
University of Pennsylvania - Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
Austin Neuromuscular Center	Austin	Texas
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
Queen Elizabeth University Hospital	Glasgow	United Kingdom
Oxford University Hospitals NHS Trust	Oxford	United Kingdom

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Other trials for the same condition

A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05405361 on ClinicalTrials.gov ↗ ← All trials in Germany