A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy
NCT ID: NCT06742190
Last Updated: 2026-01-15
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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RECRUITING
PHASE3
115 participants
INTERVENTIONAL
2024-12-18
2029-12-31
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
QUADRUPLE
Study Groups
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Part A - empasiprubart + IVIg-placebo
During the double blinded - double dummy part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm
Empasiprubart
Intravenous infusion of empasiprubart
IVIg-placebo
A placebo resembling the IVIg treatment
Part A - IVIg + empasiprubart-placebo
During the double blinded - double dummy part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm
IVIG (Intravenous Immunoglobulin)
Intravenous infusion of IVIg
Empasiprubart-placebo
A placebo resembling the empasiprubart treatment
Part B - empasiprubart
After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg)
Empasiprubart
Intravenous infusion of empasiprubart
Interventions
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Empasiprubart
Intravenous infusion of empasiprubart
IVIG (Intravenous Immunoglobulin)
Intravenous infusion of IVIg
Empasiprubart-placebo
A placebo resembling the empasiprubart treatment
IVIg-placebo
A placebo resembling the IVIg treatment
Eligibility Criteria
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Inclusion Criteria
* Has a confirmed diagnosis of definite or probable MMN at screening according to the EFNS/PNS 2010 guidelines
* Has responded to IVIg in the past 5 years.
* Is receiving IVIg at a treatment interval of once every 2, 3, 4, or 5 weeks, and a dose of 0.4 to 2.0 g/kg body weight per cycle
* Is receiving a maintenance regimen (no change in frequency, and no change in dose \>10%) of IVIg for at least 8 weeks before screening (or at least 10 weeks for participants receiving IVIg once every 5 weeks)
* Minimum converted weekly IVIg dose of ≥0.125 g/kg
* Has documented immunization against encapsulated bacterial pathogens (N meningitidis and S pneumoniae) within 5 years of screening or is willing to receive immunization at least 14 days before first study drug administration
Exclusion Criteria
* Clinical signs or symptoms suggestive of neuropathies other than MMN, such as motor neuron disease (eg, bulbar signs, brisk reflexes) or other inflammatory neuropathies (eg, sensory neuropathy)
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
Scottsdale, Arizona, United States
The Neurology Group
Pomona, California, United States
Samir Macwan, M.D., Inc.
Rancho Mirage, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado - Anschutz Cancer Pavilion (Neuro Onc Clinic)
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Medstar Health Research Institute
Washington D.C., District of Columbia, United States
EZR Research LLC
Boca Raton, Florida, United States
Healthcare Innovations Institute, LLC
Coral Springs, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States
University of Kansas Medical Center
Fairway, Kansas, United States
Perelman Center for Advanced Medicine
Columbia, Maryland, United States
UC Irvine - MDA ALS and Neuromuscular Center
Columbia, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Dent Neurologic Institute Amherst
Amherst, New York, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill
Morrisville, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
National Neuromuscular Research Institute
Austin, Texas, United States
NeuroCarePlus
Houston, Texas, United States
Royal Melbourne Hospital
Parkville, , Australia
Gold Coast University Hospital
Southport, , Australia
Brain and Mind Center
Sydney, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Universitätsklinikum AKH Wien
Vienna, , Austria
UZ Antwerpen
Edegem, , Belgium
UZ Leuven
Leuven, , Belgium
Hôpital de la Citadelle
Liège, , Belgium
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, , Brazil
PSEG Centro de Pesquisa Clínica
São Paulo, , Brazil
Neuro-Outaouais Clinic
Gatineau, , Canada
London Health Sciences Centre
London, , Canada
Huashan Hospital Fudan University
Shanghai, , China
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, , Czechia
Aarhus Universitetshospital
Aarhus, , Denmark
Rigshospitalet-Inge Lehmanns Vej 8
Copenhagen, , Denmark
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, , France
CHU de Brest - Hôpital La Cavale Blanche
Brest, , France
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, , France
AP-HP - Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital Roger Salengro
Lille, , France
CHU Limoges - Dupuytren 1
Limoges, , France
AP-HM- Hôpital de La Timone
Marseille, , France
AP-HM- Hôpital de La Timone
Marseille, , France
CHU de Nice-Hôpital Pasteur
Nice, , France
AP-HP - Hôpital de la Pitié Salpétrière
Paris, , France
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, , France
Universitätsklinikum Essen
Essen, , Germany
Universität Georg August
Göttingen, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, , Germany
Universitätsklinikum Münster
Münster, , Germany
Alexianer - MVZ St. Josefs-Krankenhaus Potsdam GmbH
Potsdam, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári, , Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, , Greece
Ospedale Policlinico San Martino IRCCS
Genova, , Italy
Fondazione Serena Onlus - Centro Clinico NeMO Brescia
Gussago, , Italy
Az. Ospedaliera Universitaria Policlinico G. Martino
Messina, , Italy
Ospedale San Raffaele S.r.l.
Milan, , Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Milan, , Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, , Italy
Fondazione PTV Policlinico Tor Vergata
Roma, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano, , Italy
Juntendo University Hospital
Bunkyō City, , Japan
Institute of Science Tokyo Hospital
Bunkyō City, , Japan
Chiba University Hospital
Chūōku, , Japan
National Center of Neurology and Psychiatry
Kodaira, , Japan
Nagoya University Hospital
Nagoya, , Japan
Yamaguchi University Hospital
Ube, , Japan
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, , Lithuania
Amsterdam UMC
Amsterdam, , Netherlands
Oslo Universitetssykehus HF, Ullevål
Oslo, , Norway
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, , Poland
Centrum Medyczne Neurologia Slaska
Katowice, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Galen Clinic -- Lublin
Lublin, , Poland
UCK WUM, Centralny Szpital Kliniczny
Warsaw, , Poland
ULS de Santo António, EPE - Hospital de Santo António
Porto, , Portugal
University Clinical Center of Serbia
Belgrade, , Serbia
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Univerzitna nemocnica MARTIN
Martin, , Slovakia
University Medical Centre Ljubljana
Ljubljana, , Slovenia
Hospital General Universitario Dr. Balmis
Alicante, , Spain
Hospital Universitario Germans Trias i Pujol
Badalona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario de Bellvitge
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario de Basurto
Madrid, , Spain
Hospital Quironsalud Malaga
Málaga, , Spain
Hospital Universitario de Donostia
San Sebastián, , Spain
Inselspital - Universitätsspital Bern
Bern, , Switzerland
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-516473-72-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARGX-117-2302
Identifier Type: -
Identifier Source: org_study_id
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