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

NCT06742190 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: ARGX-117-23022024-516473-72-00
• Study Type: interventional
• Target: 115
• Locations: 24 countries
• Sites: 106

Brief 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

Conditions

MMN; Multifocal Motor Neuropathy (MMN)

Outcome Measures

Primary Outcomes (1)

• Change from baseline in grip strength (3-day moving average) in the most affected hand at week 24

  Up to 24 weeks

Secondary Outcomes (21)

• Change from baseline in MMN-RODS centile score at week 24

  Up to 24 weeks

• Change from baseline in mMRC-14 sum score

  Up to 24 weeks (Part A), Up to 120 weeks (Part B)

• PGI-C actual value

  Up to 24 weeks (Part A), Up to 120 weeks (Part B)

• Change from baseline in CAP-PRI total score

  Up to 24 weeks (Part A), Up to 120 weeks (Part B)

• Percentage change from baseline in time to complete the 9-HPT with the dominant hand

  Up to 24 weeks (Part A), Up to 120 weeks (Part B)

Study Arms (3)

Part A - empasiprubart + IVIg-placebo

EXPERIMENTAL

During the double blinded - double dummy part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm

Biological: Empasiprubart; Other: IVIg-placebo

Part A - IVIg + empasiprubart-placebo

ACTIVE COMPARATOR

During the double blinded - double dummy part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm

Biological: IVIG (Intravenous Immunoglobulin); Other: Empasiprubart-placebo

Part B - empasiprubart

EXPERIMENTAL

After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg)

Biological: Empasiprubart

Interventions

Empasiprubart BIOLOGICAL

Intravenous infusion of empasiprubart

Part A - empasiprubart + IVIg-placebo; Part B - empasiprubart

IVIG (Intravenous Immunoglobulin) BIOLOGICAL

Intravenous infusion of IVIg

Part A - IVIg + empasiprubart-placebo

Empasiprubart-placebo OTHER

A placebo resembling the empasiprubart treatment

Part A - IVIg + empasiprubart-placebo

IVIg-placebo OTHER

A placebo resembling the IVIg treatment

Part A - empasiprubart + IVIg-placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• argenx: lead

Study Sites (109)

HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology

Scottsdale, Arizona, 85251, United States

ACTIVE NOT RECRUITING

The Neurology Group

Pomona, California, 91767, United States

ACTIVE NOT RECRUITING

Samir Macwan, M.D., Inc.

Rancho Mirage, California, 92270, United States

ACTIVE NOT RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

ACTIVE NOT RECRUITING

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

Aurora, Colorado, 80045, United States

ACTIVE NOT RECRUITING

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

ACTIVE NOT RECRUITING

Medstar Health Research Institute

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

ACTIVE NOT RECRUITING

EZR Research LLC

Boca Raton, Florida, 33486, United States

ACTIVE NOT RECRUITING

Healthcare Innovations Institute, LLC

Coral Springs, Florida, 33067, United States

ACTIVE NOT RECRUITING

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

ACTIVE NOT RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

ACTIVE NOT RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

ACTIVE NOT RECRUITING

Indiana University Health Neuroscience Center

Indianapolis, Indiana, 46202, United States

ACTIVE NOT RECRUITING

University of Kansas Medical Center

Fairway, Kansas, 66205, United States

ACTIVE NOT RECRUITING

Perelman Center for Advanced Medicine

Columbia, Maryland, 21044, United States

ACTIVE NOT RECRUITING

UC Irvine - MDA ALS and Neuromuscular Center

Columbia, Maryland, 21044, United States

ACTIVE NOT RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55414, United States

ACTIVE NOT RECRUITING

Dent Neurologic Institute Amherst

Amherst, New York, 14226, United States

ACTIVE NOT RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

ACTIVE NOT RECRUITING

University of North Carolina at Chapel Hill

Morrisville, North Carolina, 27560, United States

ACTIVE NOT RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

ACTIVE NOT RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

ACTIVE NOT RECRUITING

National Neuromuscular Research Institute

Austin, Texas, 78759-8402, United States

ACTIVE NOT RECRUITING

NeuroCarePlus

Houston, Texas, 77094, United States

ACTIVE NOT RECRUITING

Royal Melbourne Hospital

Parkville, 3050, Australia

ACTIVE NOT RECRUITING

Gold Coast University Hospital

Southport, 4215, Australia

ACTIVE NOT RECRUITING

Brain and Mind Center

Sydney, 2609, Australia

ACTIVE NOT RECRUITING

Princess Alexandra Hospital

Woolloongabba, 4102, Australia

ACTIVE NOT RECRUITING

Universitätsklinikum AKH Wien

Vienna, 1090, Austria

ACTIVE NOT RECRUITING

UZ Antwerpen

Edegem, 2650, Belgium

ACTIVE NOT RECRUITING

UZ Leuven

Leuven, 3000, Belgium

ACTIVE NOT RECRUITING

Hôpital de la Citadelle

Liège, 4000, Belgium

ACTIVE NOT RECRUITING

Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, 14051, Brazil

ACTIVE NOT RECRUITING

Sociedade de Ensino Superior Estacio de Sa Ltda

Rio de Janeiro, 22620-172, Brazil

ACTIVE NOT RECRUITING

Escola Bahiana de Medicina e Saude Publica

Salvador, 40290-000, Brazil

ACTIVE NOT RECRUITING

PSEG Centro de Pesquisa Clínica

São Paulo, 04038-002, Brazil

ACTIVE NOT RECRUITING

Neuro-Outaouais Clinic

Gatineau, J8Y 1W2, Canada

ACTIVE NOT RECRUITING

London Health Sciences Centre

London, N6A 5A5, Canada

ACTIVE NOT RECRUITING

St. Paul's Neurology Associates

Vancouver, V6Z 2H2, Canada

ACTIVE NOT RECRUITING

Huashan Hospital Fudan University

Shanghai, 200040, China

ACTIVE NOT RECRUITING

Fakultni nemocnice Brno

Brno, 625 00, Czechia

ACTIVE NOT RECRUITING

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

ACTIVE NOT RECRUITING

Vseobecna Fakultni Nemocnice V Praze

Prague, 128 08, Czechia

ACTIVE NOT RECRUITING

Aarhus Universitetshospital

Aarhus, 8200, Denmark

ACTIVE NOT RECRUITING

Rigshospitalet-Inge Lehmanns Vej 8

Copenhagen, 2100, Denmark

ACTIVE NOT RECRUITING

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33000, France

ACTIVE NOT RECRUITING

CHU de Brest - Hôpital La Cavale Blanche

Brest, 29609, France

ACTIVE NOT RECRUITING

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, 69500, France

ACTIVE NOT RECRUITING

AP-HP - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

ACTIVE NOT RECRUITING

Hôpital Roger Salengro

Lille, 59000, France

ACTIVE NOT RECRUITING

CHU Limoges - Dupuytren 1

Limoges, 87042, France

ACTIVE NOT RECRUITING

AP-HM- Hôpital de La Timone

Marseille, 13005, France

ACTIVE NOT RECRUITING

AP-HM- Hôpital de La Timone

Marseille, 13385, France

ACTIVE NOT RECRUITING

CHU de Nice-Hôpital Pasteur

Nice, 6001, France

ACTIVE NOT RECRUITING

AP-HP - Hôpital de la Pitié Salpétrière

Paris, 75013, France

ACTIVE NOT RECRUITING

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67200, France

ACTIVE NOT RECRUITING

Universitätsklinikum Essen

Essen, 45147, Germany

ACTIVE NOT RECRUITING

Universität Georg August

Göttingen, 37075, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, 23538, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Münster

Münster, 48149, Germany

ACTIVE NOT RECRUITING

Alexianer - MVZ St. Josefs-Krankenhaus Potsdam GmbH

Potsdam, 14471, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

ACTIVE NOT RECRUITING

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

Chaïdári, 124 62, Greece

ACTIVE NOT RECRUITING

AHEPA University General Hospital of Thessaloniki

Thessaloniki, 546 36, Greece

ACTIVE NOT RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

ACTIVE NOT RECRUITING

Ospedale Policlinico San Martino IRCCS

Genova, 16132, Italy

ACTIVE NOT RECRUITING

Fondazione Serena Onlus - Centro Clinico NeMO Brescia

Gussago, 25064, Italy

ACTIVE NOT RECRUITING

Az. Ospedaliera Universitaria Policlinico G. Martino

Messina, 98124, Italy

ACTIVE NOT RECRUITING

Ospedale San Raffaele S.r.l.

Milan, 20132, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Milan, 20133, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, 00189, Italy

ACTIVE NOT RECRUITING

Fondazione PTV Policlinico Tor Vergata

Roma, 133, Italy

ACTIVE NOT RECRUITING

IRCCS Istituto Clinico Humanitas

Rozzano, 20089, Italy

ACTIVE NOT RECRUITING

Juntendo University Hospital

Bunkyō City, 113-8431, Japan

ACTIVE NOT RECRUITING

Institute of Science Tokyo Hospital

Bunkyō City, 113-8519, Japan

ACTIVE NOT RECRUITING

Chiba University Hospital

Chūōku, 260-8677, Japan

ACTIVE NOT RECRUITING

National Center of Neurology and Psychiatry

Kodaira, 187-8502, Japan

ACTIVE NOT RECRUITING

Nagoya University Hospital

Nagoya, 4668560, Japan

ACTIVE NOT RECRUITING

Teikyo University Hospital

tabashi City, 173-8606, Japan

RECRUITING

Yamaguchi University Hospital

Ube, 755-0067, Japan

ACTIVE NOT RECRUITING

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

ACTIVE NOT RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, 50161, Lithuania

ACTIVE NOT RECRUITING

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

ACTIVE NOT RECRUITING

Oslo Universitetssykehus HF, Ullevål

Oslo, 0450, Norway

ACTIVE NOT RECRUITING

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, 85-065, Poland

ACTIVE NOT RECRUITING

Centrum Medyczne Neurologia Slaska

Katowice, 40-689, Poland

ACTIVE NOT RECRUITING

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

ACTIVE NOT RECRUITING

Galen Clinic -- Lublin

Lublin, 20--64, Poland

ACTIVE NOT RECRUITING

UCK WUM, Centralny Szpital Kliniczny

Warsaw, 02-097, Poland

ACTIVE NOT RECRUITING

ULS de Santo António, EPE - Hospital de Santo António

Porto, 4099-001, Portugal

ACTIVE NOT RECRUITING

University Clinical Center of Serbia

Belgrade, 11000, Serbia

ACTIVE NOT RECRUITING

Univerzitna nemocnica Bratislava

Bratislava, 821 01, Slovakia

ACTIVE NOT RECRUITING

Univerzitna nemocnica MARTIN

Martin, 036 59, Slovakia

ACTIVE NOT RECRUITING

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

ACTIVE NOT RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, 03010, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Germans Trias i Pujol

Badalona, 08916, Spain

ACTIVE NOT RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

ACTIVE NOT RECRUITING

Hospital de La Santa Creu i Sant Pau

Barcelona, 08041, Spain

ACTIVE NOT RECRUITING

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

ACTIVE NOT RECRUITING

Hospital Clinico San Carlos

Madrid, 28039, Spain

ACTIVE NOT RECRUITING

Hospital Universitario de Basurto

Madrid, 48013, Spain

ACTIVE NOT RECRUITING

Hospital Quironsalud Malaga

Málaga, 29004, Spain

ACTIVE NOT RECRUITING

Hospital Universitario de Donostia

San Sebastián, 8035, Spain

ACTIVE NOT RECRUITING

Inselspital - Universitätsspital Bern

Bern, 3010, Switzerland

ACTIVE NOT RECRUITING

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

ACTIVE NOT RECRUITING

John Radcliffe Hospital

Oxford, OX3 7LE, United Kingdom

ACTIVE NOT RECRUITING

Salford Royal Hospital

Salford, M6 8HD, United Kingdom

ACTIVE NOT RECRUITING

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

ACTIVE NOT RECRUITING

Musgrove Park Hospital

Taunton, TA1 5DA, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (1)

• Caballero-Avila M, Pascual-Goni E, Lleixa C, Martin-Aguilar L, Collet-Vidiella R, Querol L. The changing landscape of primary autoimmune neuropathies. Nat Rev Neurol. 2025 Oct;21(10):544-555. doi: 10.1038/s41582-025-01133-3. Epub 2025 Sep 5.

  PMID: 40913126 DERIVED

Related Links

• Study website

MeSH Terms

Interventions

Immunoglobulins, Intravenous

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: December 18, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1); CH (1); AU (4); IT (9); LA (1); NO (1); GB (5); BR (4); DE (6); CA (3); ES (9); JP (7); GR (2); PL (5); FR (11); PT (1); CN (1); DK (2); SE (1); US (24); CZ (3); LI (1); BE (3); NL (1)