A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
Status: Recruiting
Location: See all (74) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months). More information can be found here: https://clinicaltrials.argenx.com/emvigorate
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
• Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
• Has responded to IVIg in the past 5 years
• Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg
• Has residual disability and active disease
Locations
United States
California
Samir Macwan, M.D., Inc.
RECRUITING
Rancho Mirage
Colorado
Colorado Springs Neurological Associates
RECRUITING
Colorado Springs
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Homestead Associates in Research Inc
RECRUITING
Homestead
Visionary Investigators Network
RECRUITING
Miami
University of South Florida
RECRUITING
Tampa
Louisiana
Paradigm Health System
RECRUITING
Slidell
Maryland
Erlanger Health System
RECRUITING
Columbia
Michigan
University of Michigan Hospital
RECRUITING
Ann Arbor
Texas
NeuroCarePlus
RECRUITING
Houston
National Neuromuscular Research Institute
RECRUITING
Irving
Other Locations
Argentina
INECO Neurociencias Oroño
RECRUITING
Rosario
Austria
Universitätsklinikum AKH Wien
RECRUITING
Vienna
Estonia
Astra Kliinik
RECRUITING
Tallinn
Tartu University Hospital
RECRUITING
Tartu
France
CHU de Bordeaux - Hôpital Pellegrin
RECRUITING
Bordeaux
AP-HP - Hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
CHU de Nice-Hôpital Pasteur
RECRUITING
Nice
AP-HP - Hôpital de la Pitié Salpétrière
ACTIVE_NOT_RECRUITING
Paris
CHU de Strasbourg - Hôpital de Hautepierre
RECRUITING
Strasbourg
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
RECRUITING
Toulouse
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Universitätsklinikum Schleswig-Holstein - Campus Kiel
RECRUITING
Kiel
Greece
University General Hospital of Alexandroupolis
RECRUITING
Athens
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
RECRUITING
Chaïdári
Israel
The Barzilai University Medical Center
RECRUITING
Ashkelon
Hadassah Medical Center- Ein Kerem
RECRUITING
Jerusalem
The Chaim Sheba Medical Center
RECRUITING
Tel Litwinsky
Italy
AUSL di Bologna - Ospedale Bellaria
RECRUITING
Bologna
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
RECRUITING
Pavia
Azienda Ospedaliero-Universitaria Policlinico Umberto I
RECRUITING
Roma
Azienda Ospedaliero-Universitaria Sant'Andrea
RECRUITING
Roma
Japan
Aomori Prefectural Central Hospital
RECRUITING
Aomori
Juntendo University Hospital
RECRUITING
Bunkyō City
Chiba University Hospital
RECRUITING
Chūōku
Juntendo Shizuoka University Hospital
RECRUITING
Izunokuni
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Saga University Hospital
RECRUITING
Saga
General Hospital Tsuchiura Kyodo Hospital
RECRUITING
Tsuchiura
Yamaguchi University Hospital
RECRUITING
Ube
Netherlands
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
Norway
Oslo Universitetssykehus HF, Ullevål
RECRUITING
Oslo
Poland
MICS Centrum Medyczne Bydgoszcz
RECRUITING
Bydgoszcz
Neurocentrum Bydgoszcz
RECRUITING
Bydgoszcz
Centrum Medyczne Neurologia Slaska
RECRUITING
Katowice
Centrum Medyczne Linden
RECRUITING
Krakow
SP ZOZ Szpital Uniwersytecki w Krakowie
RECRUITING
Krakow
Galen Clinic - Lublin
RECRUITING
Lublin
Clinical Research Center Sp. z o.o. Medic-R sp.k.
RECRUITING
Poznan
Centrum Medyczne Medyk
RECRUITING
Rzeszów
Uniwersytecki Szpital Kliniczny Nr 1
RECRUITING
Szczecin
Uniwersytecki Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie
RECRUITING
Szczecin
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
RECRUITING
Warsaw
Portugal
ULS de Santo António, EPE - Hospital de Santo António
RECRUITING
Porto
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Konkuk University Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Romania
Institutul National de Neurologie si Boli Neurovasculare Bucuresti
RECRUITING
Bucharest
Brainaxy Clinic SRL
RECRUITING
Constanța
Targu-Mures Emergency Clinical County Hospital
RECRUITING
Târgu Mureş
Serbia
University Clinical Center of Serbia - Dr Subotica 6
RECRUITING
Belgrade
University Clinical Center Nis
RECRUITING
Niš
Singapore
National Neuroscience Institute
RECRUITING
Singapore
Slovakia
Univerzitna nemocnica MARTIN
RECRUITING
Martin
Slovenia
University Medical Centre Ljubljana
RECRUITING
Ljubljana
University Clinical Centre Maribor
RECRUITING
Maribor
Spain
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario Vall d'Hebron
RECRUITING
Sant Andreu De La Barca
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Switzerland
Hôpitaux Universitaires de Genève (HUG)
RECRUITING
Geneva
Turkey
Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
RECRUITING
Samsun
United Kingdom
Salford Royal Hospital - PPDS
ACTIVE_NOT_RECRUITING
Salford
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date: 2025-08-22
Estimated Completion Date: 2030-09
Participants
Target number of participants: 218
Treatments
Experimental: Part A - empasiprubart + IVIg-placebo
During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.
Active_comparator: Part A - IVIg + empasiprubart-placebo
During 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). Participants from the empasiprubart + IVIg- placebo arm in Part A will receive empasiprubart placebo once to maintain the blind of Part A.
Related Therapeutic Areas
Sponsors
Leads: argenx