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
NCT ID: NCT05405361
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
51 participants
INTERVENTIONAL
2023-01-18
2029-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ARGX-117
Participants receiving ARGX-117 during the double-blinded treatment period (DTP) and the open-label treatment period (OLTP)
ARGX-117
Intravenous administration of ARGX-117
Placebo
Participants receiving placebo during the double-blinded treatment period (DTP) and receiving ARGX-117 during the open-label treatment period (OLTP)
ARGX-117
Intravenous administration of ARGX-117
Placebo
Intravenous administration of placebo
Interventions
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ARGX-117
Intravenous administration of ARGX-117
Placebo
Intravenous administration of placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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2023-507052-69-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARGX-117-2003
Identifier Type: -
Identifier Source: org_study_id
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