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

Status: Recruiting
Location: See all (95) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
RECRUITING
Scottsdale
California
The Neurology Group
RECRUITING
Pomona
University of California San Francisco
RECRUITING
San Francisco
Colorado
University of Colorado - Anschutz Cancer Pavilion (Neuro Onc Clinic)
RECRUITING
Aurora
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Washington, D.c.
Medstar Health Research Institute
RECRUITING
Washington D.c.
Florida
EZR Research LLC
RECRUITING
Boca Raton
Healthcare Innovations Institute, LLC
RECRUITING
Coral Springs
University of Miami Miller School of Medicine
RECRUITING
Miami
University of South Florida
RECRUITING
Tampa
Illinois
Northwestern University
RECRUITING
Chicago
Indiana
Indiana University Health Neuroscience Center
RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center
RECRUITING
Fairway
Maryland
Perelman Center for Advanced Medicine
RECRUITING
Columbia
UC Irvine - MDA ALS and Neuromuscular Center
RECRUITING
Columbia
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Morrisville
New York
Dent Neurologic Institute Amherst
RECRUITING
Amherst
Columbia University Medical Center
RECRUITING
New York
Ohio
The Cleveland Clinic Foundation
RECRUITING
Cleveland
Oregon
Oregon Health and Science University
RECRUITING
Portland
Texas
National Neuromuscular Research Institute
RECRUITING
Austin
NeuroCarePlus
RECRUITING
Houston
Other Locations
Australia
Royal Melbourne Hospital
RECRUITING
Parkville
Gold Coast University Hospital
RECRUITING
Southport
Brain and Mind Center
RECRUITING
Sydney
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Universitätsklinikum AKH Wien
RECRUITING
Vienna
Belgium
UZ Antwerpen
RECRUITING
Edegem
UZ Leuven
RECRUITING
Leuven
Hôpital de la Citadelle
RECRUITING
Liège
Brazil
PSEG Centro de Pesquisa Clínica
RECRUITING
São Paulo
Canada
Neuro-Outaouais Clinic
RECRUITING
Gatineau
London Health Sciences Centre
RECRUITING
London
China
Huashan Hospital Fudan University
RECRUITING
Shanghai
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus
Rigshospitalet-Inge Lehmanns Vej 8
RECRUITING
Copenhagen
France
CHU de Bordeaux - Hôpital Pellegrin
RECRUITING
Bordeaux
CHU de Brest - Hôpital La Cavale Blanche
RECRUITING
Brest
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
RECRUITING
Bron
AP-HP - Hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
Hôpital Roger Salengro
RECRUITING
Lille
CHU Limoges - Dupuytren 1
RECRUITING
Limoges
AP-HM- Hôpital de La Timone
RECRUITING
Marseille
AP-HM- Hôpital de La Timone
RECRUITING
Marseille
CHU de Nice-Hôpital Pasteur
RECRUITING
Nice
AP-HP - Hôpital de la Pitié Salpétrière
RECRUITING
Paris
CHU de Strasbourg - Hôpital de Hautepierre
RECRUITING
Strasbourg
Germany
Universitätsklinikum Essen
RECRUITING
Essen
Universität Georg August
RECRUITING
Göttingen
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
RECRUITING
Lübeck
Universitätsklinikum Münster
RECRUITING
Münster
Alexianer - MVZ St. Josefs-Krankenhaus Potsdam GmbH
RECRUITING
Potsdam
Universitätsklinikum Würzburg
RECRUITING
Würzburg
Greece
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
RECRUITING
Chaïdári
AHEPA University General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Italy
Ospedale Policlinico San Martino IRCCS
RECRUITING
Genova
Fondazione Serena Onlus - Centro Clinico NeMO Brescia
RECRUITING
Gussago
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
RECRUITING
Milan
Ospedale San Raffaele S.r.l.
RECRUITING
Milan
Azienda Ospedaliero-Universitaria Sant'Andrea
RECRUITING
Roma
Fondazione PTV Policlinico Tor Vergata
RECRUITING
Roma
IRCCS Istituto Clinico Humanitas
RECRUITING
Rozzano
Japan
Institute of Science Tokyo Hospital
RECRUITING
Bunkyō City
Juntendo University Hospital
RECRUITING
Bunkyō City
Chiba University Hospital
RECRUITING
Chūōku
National Center of Neurology and Psychiatry
RECRUITING
Kodaira
Nagoya University Hospital
RECRUITING
Nagoya
Yamaguchi University Hospital
RECRUITING
Ube
Latvia
Pauls Stradins Clinical University Hospital
RECRUITING
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos
RECRUITING
Kaunas
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Norway
Oslo Universitetssykehus HF, Ullevål
RECRUITING
Oslo
Poland
MICS Centrum Medyczne Bydgoszcz
RECRUITING
Bydgoszcz
Centrum Medyczne Neurologia Slaska
RECRUITING
Katowice
SP ZOZ Szpital Uniwersytecki w Krakowie
RECRUITING
Krakow
Galen Clinic -- Lublin
RECRUITING
Lublin
UCK WUM, Centralny Szpital Kliniczny
RECRUITING
Warsaw
Portugal
ULS de Santo António, EPE - Hospital de Santo António
RECRUITING
Porto
Serbia
University Clinical Center of Serbia
RECRUITING
Belgrade
Slovakia
Univerzitna nemocnica Bratislava
RECRUITING
Bratislava
Univerzitna nemocnica MARTIN
RECRUITING
Martin
Slovenia
University Medical Centre Ljubljana
RECRUITING
Ljubljana
Spain
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital Universitario Germans Trias i Pujol
RECRUITING
Badalona
Hospital de La Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario de Bellvitge
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario de Basurto
RECRUITING
Madrid
Hospital Quironsalud Malaga
RECRUITING
Málaga
Hospital Universitario de Donostia
RECRUITING
San Sebastián
Switzerland
Inselspital - Universitätsspital Bern
RECRUITING
Bern
United Kingdom
Queen Elizabeth University Hospital
RECRUITING
Glasgow
John Radcliffe Hospital
RECRUITING
Oxford
Musgrove Park Hospital
RECRUITING
Taunton
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2029-12
Participants
Target number of participants: 115
Treatments
Experimental: 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
Active_comparator: 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
Experimental: Part B - empasiprubart
After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg)
Related Therapeutic Areas
Sponsors
Leads: argenx

This content was sourced from clinicaltrials.gov