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New drug aims to replace IVIg for nerve disease

NCT ID NCT06742190

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if a new drug, empasiprubart, works as well as standard IVIg treatment for adults with multifocal motor neuropathy (MMN), a condition that causes muscle weakness. About 154 people who have responded to IVIg in the past will be randomly assigned to receive either empasiprubart or IVIg, and then all will receive empasiprubart in an open-label phase. The main goal is to see if grip strength improves over 24 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

154 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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: * Besides the indication under study, known autoimmune disease (eg, SLE) or any other medical condition that would confound the study results or put the participant at undue risk * 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)

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Conditions

The condition(s) this trial relates to.

multifocal motor neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MMN Multifocal motor neuropathy (MMN)

Contacts and locations

Locations

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki, 546 36, Greece

  • AP-HM- Hôpital de La Timone

    Marseille, 13005, France

  • AP-HM- Hôpital de La Timone

    Marseille, 13385, France

  • AP-HP - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • AP-HP - Hôpital de la Pitié Salpétrière

    Paris, 75013, France

  • Aarhus Universitetshospital

    Aarhus, 8200, Denmark

  • Alexianer - MVZ St. Josefs-Krankenhaus Potsdam GmbH

    Potsdam, 14471, Germany

  • Amsterdam UMC

    Amsterdam, 1105 AZ, Netherlands

  • Az. Ospedaliera Universitaria Policlinico G. Martino

    Messina, 98124, Italy

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134, Italy

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Milan, 20133, Italy

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    Roma, 00189, Italy

  • Brain and Mind Center

    Sydney, 2609, Australia

  • CHU Limoges - Dupuytren 1

    Limoges, 87042, France

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33000, France

  • CHU de Brest - Hôpital La Cavale Blanche

    Brest, 29609, France

  • CHU de Nice-Hôpital Pasteur

    Nice, 6001, France

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200, France

  • Centrum Medyczne Neurologia Slaska

    Katowice, 40-689, Poland

  • Chiba University Hospital

    Chūōku, 260-8677, Japan

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dent Neurologic Institute Amherst

    Amherst, New York, 14226, United States

  • EZR Research LLC

    Boca Raton, Florida, 33486, United States

  • Escola Bahiana de Medicina e Saude Publica

    Salvador, 40290-000, Brazil

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Fondazione PTV Policlinico Tor Vergata

    Roma, 133, Italy

  • Fondazione Serena Onlus - Centro Clinico NeMO Brescia

    Gussago, 25064, Italy

  • Galen Clinic -- Lublin

    Lublin, 20--64, Poland

  • Gold Coast University Hospital

    Southport, 4215, Australia

  • Healthcare Innovations Institute, LLC

    Coral Springs, Florida, 33067, United States

  • HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology

    Scottsdale, Arizona, 85251, United States

  • Hospices Civils de Lyon - Hôpital Pierre Wertheimer

    Bron, 69500, France

  • Hospital Clinico San Carlos

    Madrid, 28039, Spain

  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto

    Ribeirão Preto, 14051, Brazil

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010, Spain

  • Hospital Quironsalud Malaga

    Málaga, 29004, Spain

  • Hospital Universitario Germans Trias i Pujol

    Badalona, 08916, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario de Basurto

    Madrid, 48013, Spain

  • Hospital Universitario de Bellvitge

    Barcelona, 08907, Spain

  • Hospital Universitario de Donostia

    San Sebastián, 8035, Spain

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, 50161, Lithuania

  • Huashan Hospital Fudan University

    Shanghai, 200040, China

  • Hôpital Roger Salengro

    Lille, 59000, France

  • Hôpital de la Citadelle

    Liège, 4000, Belgium

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Indiana University Health Neuroscience Center

    Indianapolis, Indiana, 46202, United States

  • Inselspital - Universitätsspital Bern

    Bern, 3010, Switzerland

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113-8519, Japan

  • John Radcliffe Hospital

    Oxford, OX3 7LE, United Kingdom

  • Juntendo University Hospital

    Bunkyō City, 113-8431, Japan

  • London Health Sciences Centre

    London, N6A 5A5, Canada

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065, Poland

  • Medstar Health Research Institute

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

  • Musgrove Park Hospital

    Taunton, TA1 5DA, United Kingdom

  • Nagoya University Hospital

    Nagoya, 4668560, Japan

  • National Center of Neurology and Psychiatry

    Kodaira, 187-8502, Japan

  • National Neuromuscular Research Institute

    Austin, Texas, 78759-8402, United States

  • Neuro-Outaouais Clinic

    Gatineau, J8Y 1W2, Canada

  • NeuroCarePlus

    Houston, Texas, 77094, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Oslo Universitetssykehus HF, Ullevål

    Oslo, 0450, Norway

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132, Italy

  • Ospedale San Raffaele S.r.l.

    Milan, 20132, Italy

  • PSEG Centro de Pesquisa Clínica

    São Paulo, 04038-002, Brazil

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002, Latvia

  • Perelman Center for Advanced Medicine

    Columbia, Maryland, 21044, United States

  • Princess Alexandra Hospital

    Woolloongabba, 4102, Australia

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Rigshospitalet-Inge Lehmanns Vej 8

    Copenhagen, 2100, Denmark

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF, United Kingdom

  • Royal Melbourne Hospital

    Parkville, 3050, Australia

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 30-688, Poland

  • Salford Royal Hospital

    Salford, M6 8HD, United Kingdom

  • Samir Macwan, M.D., Inc.

    Rancho Mirage, California, 92270, United States

  • Sociedade de Ensino Superior Estacio de Sa Ltda

    Rio de Janeiro, 22620-172, Brazil

  • St. Paul's Neurology Associates

    Vancouver, V6Z 2H2, Canada

  • Teikyo University Hospital

    tabashi City, 173-8606, Japan

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The Neurology Group

    Pomona, California, 91767, United States

  • UC Irvine - MDA ALS and Neuromuscular Center

    Columbia, Maryland, 21044, United States

  • UCK WUM, Centralny Szpital Kliniczny

    Warsaw, 02-097, Poland

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

    Porto, 4099-001, Portugal

  • UZ Antwerpen

    Edegem, 2650, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • University Clinical Center of Serbia

    Belgrade, 11000, Serbia

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

    Chaïdári, 124 62, Greece

  • University Medical Centre Ljubljana

    Ljubljana, 1000, Slovenia

  • University of California San Francisco

    San Francisco, California, 94143, United States

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

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    Fairway, Kansas, 66205, United States

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55414, United States

  • University of North Carolina at Chapel Hill

    Morrisville, North Carolina, 27560, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • Universität Georg August

    Göttingen, 37075, Germany

  • Universitätsklinikum AKH Wien

    Vienna, 1090, Austria

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, 23538, Germany

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

  • Univerzitna nemocnica Bratislava

    Bratislava, 821 01, Slovakia

  • Univerzitna nemocnica MARTIN

    Martin, 036 59, Slovakia

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 128 08, Czechia

  • Yale University School of Medicine

    New Haven, Connecticut, 06511, United States

  • Yamaguchi University Hospital

    Ube, 755-0067, Japan

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