A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy

Last updated: February 13, 2026
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Empasiprubart

IVIG (Intravenous Immunoglobulin)

Empasiprubart-placebo

Clinical Study ID

NCT06742190
ARGX-117-2302
2024-516473-72-00
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is at least 18 years of age and the local legal age of consent for clinical studies

  • Has a confirmed diagnosis of definite or probable MMN at screening according to theEFNS/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 adose 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 forparticipants receiving IVIg once every 5 weeks)

  • Minimum converted weekly IVIg dose of ≥0.125 g/kg

  • Has documented immunization against encapsulated bacterial pathogens (N meningitidisand S pneumoniae) within 5 years of screening or is willing to receive immunizationat least 14 days before first study drug administration

Exclusion

Exclusion Criteria:

  • Besides the indication under study, known autoimmune disease (eg, SLE) or any othermedical condition that would confound the study results or put the participant atundue risk

  • Clinical signs or symptoms suggestive of neuropathies other than MMN, such as motorneuron disease (eg, bulbar signs, brisk reflexes) or other inflammatory neuropathies (eg, sensory neuropathy)

Study Design

Total Participants: 115
Treatment Group(s): 4
Primary Treatment: Empasiprubart
Phase: 3
Study Start date:
December 18, 2024
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Royal Melbourne Hospital

    Parkville 2153770, 3050
    Australia

    Active - Recruiting

  • Gold Coast University Hospital

    Southport 2148928, 4215
    Australia

    Active - Recruiting

  • Brain and Mind Center

    Sydney 2147714, 2609
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba 6943568, 4102
    Australia

    Active - Recruiting

  • Universitätsklinikum AKH Wien

    Vienna 2761369, 1090
    Austria

    Active - Recruiting

  • UZ Antwerpen

    Edegem 2799007, 2650
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven 2792482, 3000
    Belgium

    Active - Recruiting

  • Hôpital de la Citadelle

    Liège 2792413, 4000
    Belgium

    Active - Recruiting

  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto

    Ribeirão Preto 3451328, 14051
    Brazil

    Active - Recruiting

  • Sociedade de Ensino Superior Estacio de Sa Ltda

    Rio de Janeiro 3451190, 22620-172
    Brazil

    Active - Recruiting

  • Escola Bahiana de Medicina e Saude Publica

    Salvador 3450554, 40290-000
    Brazil

    Active - Recruiting

  • PSEG Centro de Pesquisa Clínica

    São Paulo 3448439, 04038-002
    Brazil

    Active - Recruiting

  • Neuro-Outaouais Clinic

    Gatineau, J8Y 1W2
    Canada

    Site Not Available

  • Neuro-Outaouais Clinic

    Gatineau 5959974, J8Y 1W2
    Canada

    Active - Recruiting

  • London Health Sciences Centre

    London 6058560, N6A 5A5
    Canada

    Active - Recruiting

  • St. Paul's Neurology Associates

    Vancouver 6173331, V6Z 2H2
    Canada

    Active - Recruiting

  • Huashan Hospital Fudan University

    Shanghai 1796236, 200040
    China

    Active - Recruiting

  • Fakultni nemocnice Brno

    Brno 3078610, 625 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové 3074967, 500 05
    Czechia

    Active - Recruiting

  • Vseobecna Fakultni Nemocnice V Praze

    Prague 3067696, 128 08
    Czechia

    Active - Recruiting

  • Aarhus Universitetshospital

    Aarhus 2624652, 8200
    Denmark

    Active - Recruiting

  • Rigshospitalet-Inge Lehmanns Vej 8

    Copenhagen 2618425, 2100
    Denmark

    Active - Recruiting

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux 3031582, 33000
    France

    Active - Recruiting

  • CHU de Brest - Hôpital La Cavale Blanche

    Brest 3030300, 29609
    France

    Active - Recruiting

  • Hospices Civils de Lyon - Hôpital Pierre Wertheimer

    Bron 3029931, 69500
    France

    Active - Recruiting

  • AP-HP - Hôpital Bicêtre

    Le Kremlin-Bicêtre 3003737, 94270
    France

    Active - Recruiting

  • Hôpital Roger Salengro

    Lille 2998324, 59000
    France

    Active - Recruiting

  • CHU Limoges - Dupuytren 1

    Limoges 2998286, 87042
    France

    Active - Recruiting

  • AP-HM- Hôpital de La Timone

    Marseille 2995469, 13005
    France

    Active - Recruiting

  • CHU de Nice-Hôpital Pasteur

    Nice 2990440, 6001
    France

    Active - Recruiting

  • AP-HP - Hôpital de la Pitié Salpétrière

    Paris 2988507, 75013
    France

    Active - Recruiting

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg 2973783, 67200
    France

    Active - Recruiting

  • Universitätsklinikum Essen

    Essen 2928810, 45147
    Germany

    Active - Recruiting

  • Universität Georg August

    Göttingen 2918632, 37075
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck 2875601, 23538
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster

    Münster 2867543, 48149
    Germany

    Active - Recruiting

  • Alexianer - MVZ St. Josefs-Krankenhaus Potsdam GmbH

    Potsdam 2852458, 14471
    Germany

    Active - Recruiting

  • Universitätsklinikum Würzburg

    Würzburg 2805615, 97080
    Germany

    Active - Recruiting

  • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

    Chaïdári 260183, 124 62
    Greece

    Active - Recruiting

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki 734077, 546 36
    Greece

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence 3176959, 50134
    Italy

    Active - Recruiting

  • Ospedale Policlinico San Martino IRCCS

    Genova 8969657, 16132
    Italy

    Active - Recruiting

  • Fondazione Serena Onlus - Centro Clinico NeMO Brescia

    Gussago 3175670, 25064
    Italy

    Active - Recruiting

  • Az. Ospedaliera Universitaria Policlinico G. Martino

    Messina 2524170, 98124
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Milan 6951411, 20133
    Italy

    Active - Recruiting

  • Ospedale San Raffaele S.r.l.

    Milan 6951411, 20132
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    Roma 8957247, 00189
    Italy

    Active - Recruiting

  • Fondazione PTV Policlinico Tor Vergata

    Roma 8957247, 133
    Italy

    Active - Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano 3168837, 20089
    Italy

    Active - Recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō City 11790632, 113-8519
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyō City 11790632, 113-8431
    Japan

    Active - Recruiting

  • Chiba University Hospital

    Chūōku 10262791, 260-8677
    Japan

    Active - Recruiting

  • National Center of Neurology and Psychiatry

    Kodaira 11611930, 187-8502
    Japan

    Active - Recruiting

  • Nagoya University Hospital

    Nagoya 1856057, 4668560
    Japan

    Active - Recruiting

  • Yamaguchi University Hospital

    Ube, 755-0067
    Japan

    Site Not Available

  • Yamaguchi University Hospital

    Ube 1849498, 755-0067
    Japan

    Active - Recruiting

  • Pauls Stradins Clinical University Hospital

    Riga 456172, LV-1002
    Latvia

    Active - Recruiting

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas 598316, 50161
    Lithuania

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam 2759794, 1105 AZ
    Netherlands

    Active - Recruiting

  • Oslo Universitetssykehus HF, Ullevål

    Oslo 3143244, 0450
    Norway

    Active - Recruiting

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz 3102014, 85-065
    Poland

    Active - Recruiting

  • Centrum Medyczne Neurologia Slaska

    Katowice 3096472, 40-689
    Poland

    Active - Recruiting

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow 3094802, 30-688
    Poland

    Active - Recruiting

  • Galen Clinic -- Lublin

    Lublin 765876, 20--64
    Poland

    Active - Recruiting

  • UCK WUM, Centralny Szpital Kliniczny

    Warsaw 756135, 02-097
    Poland

    Active - Recruiting

  • ULS de Santo António, EPE - Hospital de Santo António

    Porto 2735943, 4099-001
    Portugal

    Active - Recruiting

  • University Clinical Center of Serbia

    Belgrade 792680, 11000
    Serbia

    Active - Recruiting

  • Univerzitna nemocnica Bratislava

    Bratislava 3060972, 821 01
    Slovakia

    Active - Recruiting

  • Univerzitna nemocnica MARTIN

    Martin 3058780, 036 59
    Slovakia

    Active - Recruiting

  • University Medical Centre Ljubljana

    Ljubljana 3196359, 1000
    Slovenia

    Active - Recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital General Universitario Dr. Balmis

    Alicante 2521978, 03010
    Spain

    Active - Recruiting

  • Hospital Universitario Germans Trias i Pujol

    Badalona 3129028, 08916
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario de Bellvitge

    Barcelona 3128760, 08907
    Spain

    Active - Recruiting

  • Hospital de La Santa Creu i Sant Pau

    Barcelona 3128760, 08041
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28039
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid 3117735, 28039
    Spain

    Active - Recruiting

  • Hospital Universitario de Basurto

    Madrid 3117735, 48013
    Spain

    Active - Recruiting

  • Hospital Quironsalud Malaga

    Málaga, 29004
    Spain

    Site Not Available

  • Hospital Quironsalud Malaga

    Málaga 2514256, 29004
    Spain

    Active - Recruiting

  • Hospital Universitario de Donostia

    San Sebastián 3110043, 8035
    Spain

    Active - Recruiting

  • Inselspital - Universitätsspital Bern

    Bern 2661552, 3010
    Switzerland

    Active - Recruiting

  • Queen Elizabeth University Hospital

    Glasgow 2648579, G51 4TF
    United Kingdom

    Active - Recruiting

  • John Radcliffe Hospital

    Oxford 2640729, OX3 7LE
    United Kingdom

    Active - Recruiting

  • Salford Royal Hospital

    Salford 2638671, M6 8HD
    United Kingdom

    Active - Recruiting

  • Royal Hallamshire Hospital

    Sheffield 2638077, S10 2JF
    United Kingdom

    Active - Recruiting

  • Musgrove Park Hospital

    Taunton 2636177, TA1 5DA
    United Kingdom

    Active - Recruiting

  • HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology

    Scottsdale 5313457, Arizona 5551752 85251
    United States

    Active - Recruiting

  • The Neurology Group

    Pomona, California 91767
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • The Neurology Group

    Pomona 5384170, California 5332921 91767
    United States

    Active - Recruiting

  • Samir Macwan, M.D., Inc.

    Rancho Mirage 5386015, California 5332921 92270
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • University of Colorado - Anschutz Cancer Pavilion (Neuro Onc Clinic)

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Yale University School of Medicine

    New Haven 4839366, Connecticut 4831725 06511
    United States

    Active - Recruiting

  • Medstar Health Research Institute

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Medstar Health Research Institute

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Active - Recruiting

  • Healthcare Innovations Institute, LLC

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • EZR Research LLC

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Active - Recruiting

  • Healthcare Innovations Institute, LLC

    Coral Springs 4151909, Florida 4155751 33067
    United States

    Active - Recruiting

  • University of Miami Miller School of Medicine

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • University of South Florida

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Northwestern University

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • Indiana University Health Neuroscience Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University Health Neuroscience Center

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Fairway, Kansas 66205
    United States

    Site Not Available

  • University of Kansas Medical Center

    Fairway 4271358, Kansas 4273857 66205
    United States

    Active - Recruiting

  • Perelman Center for Advanced Medicine

    Columbia 4352053, Maryland 4361885 21044
    United States

    Active - Recruiting

  • UC Irvine - MDA ALS and Neuromuscular Center

    Columbia 4352053, Maryland 4361885 21044
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis 5037649, Minnesota 5037779 55414
    United States

    Active - Recruiting

  • Dent Neurologic Institute Amherst

    Amherst, New York 14226
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Dent Neurologic Institute Amherst

    Amherst 5107129, New York 5128638 14226
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Morrisville 4480285, North Carolina 4482348 27560
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • National Neuromuscular Research Institute

    Austin, Texas 78759-8402
    United States

    Site Not Available

  • NeuroCarePlus

    Houston, Texas 77094
    United States

    Site Not Available

  • National Neuromuscular Research Institute

    Austin 4671654, Texas 4736286 78759-8402
    United States

    Active - Recruiting

  • NeuroCarePlus

    Houston 4699066, Texas 4736286 77094
    United States

    Active - Recruiting

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