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RECRUITING
NCT06742190
PHASE3

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

Sponsor: argenx

View on ClinicalTrials.gov

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. More information can be found here: https://clinicaltrials.argenx.com/empassion

Official title: A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Empasiprubart Versus Intravenous Immunoglobulin in Adults With Multifocal Motor Neuropathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2024-12-18

Completion Date

2029-12

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

Empasiprubart

Intravenous infusion of empasiprubart

BIOLOGICAL

IVIG (Intravenous Immunoglobulin)

Intravenous infusion of IVIg

OTHER

Empasiprubart-placebo

A placebo resembling the empasiprubart treatment

OTHER

IVIg-placebo

A placebo resembling the IVIg treatment

Locations (109)

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

Sociedade de Ensino Superior Estacio de Sa Ltda

Rio de Janeiro, Brazil

Escola Bahiana de Medicina e Saude Publica

Salvador, Brazil

PSEG Centro de Pesquisa Clínica

São Paulo, Brazil

Neuro-Outaouais Clinic

Gatineau, Canada

London Health Sciences Centre

London, Canada

St. Paul's Neurology Associates

Vancouver, 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

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

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

Teikyo University Hospital

tabashi City, 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

Royal Hallamshire Hospital

Sheffield, United Kingdom

Musgrove Park Hospital

Taunton, United Kingdom