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ACTIVE NOT RECRUITING
NCT05405361
PHASE2

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

Sponsor: argenx

View on ClinicalTrials.gov

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.

Official title: A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2023-01-18

Completion Date

2029-09-30

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

ARGX-117

Intravenous administration of ARGX-117

OTHER

Placebo

Intravenous administration of placebo

Locations (27)

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

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Oxford University Hospitals NHS Trust

Oxford, United Kingdom