A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
Status: Recruiting
Location: See all (88) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo 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/emnergize
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 (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
• Has residual disability and active disease
• Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)
• Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP
Locations
United States
Alabama
University of Alabama at Birmingham - 1720 University Blvd
RECRUITING
Birmingham
California
Samir Macwan, M.D., Inc. (S corporation)
RECRUITING
Rancho Mirage
Colorado
Colorado Springs Neurological Associates
RECRUITING
Colorado Springs
Washington, D.c.
Medstar Health Research Institute
RECRUITING
Washington D.c.
Florida
Gables Neurology
RECRUITING
Miami
Aqualane Clinical Research
RECRUITING
Naples
Vero Beach Neurology and Research Institute
RECRUITING
Vero Beach
Louisiana
Paradigm Health System
RECRUITING
Slidell
Pennsylvania
Jefferson Health Honickman Center
RECRUITING
Philadelphia
Penn Medicine University City
RECRUITING
Philadelphia
Tennessee
University Neurology
RECRUITING
Knoxville
Texas
National Neuromuscular Research Institute
RECRUITING
Austin
NeuroCarePlus
RECRUITING
Houston
Other Locations
Argentina
Instituto Privado Kremer
RECRUITING
Córdoba
INECO Neurociencias Oroño
RECRUITING
Rosario
Instituto Médico de la Fundación Estudios Clínicos
RECRUITING
Rosario
Austria
Kepler Universitätsklinikum Linz - Med Campus III
RECRUITING
Linz
Universitätsklinikum AKH Wien
RECRUITING
Vienna
Brazil
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
RECRUITING
Brasília
Hospital Moinhos de Vento
RECRUITING
Porto Alegre
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
RECRUITING
Pôrto Alegre
Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - UPS - PPDS
RECRUITING
Ribeirão Preto
Unidade de Pesquisa Clinica e Inovacao da Estacio
RECRUITING
Rio De Janeiro
Escola Bahiana de Medicina e Saude Publica
RECRUITING
Salvador
PSEG Centro de Pesquisa Clinica
RECRUITING
São Paulo
Bulgaria
University Multiprofile Hospital for Active Treatment
RECRUITING
Pleven
Medical Center Medika 2005 - Branch Sofia
RECRUITING
Sofia
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
RECRUITING
Sofia
China
Peking University First Hospital - Changqiao Campus
RECRUITING
Beijing
Fujian Medical University Union Hospital - Yushan Campus
RECRUITING
Fuzhou
Guangdong Provincial Hospital of Chinese Medicine
RECRUITING
Guangzhou
Nanfang Hospital Southern Medical University
RECRUITING
Guangzhou
The People's Hospital of Baiyun District Guangzhou
RECRUITING
Guangzhou
Xi'an Gaoxin Hospital
RECRUITING
Xi'an
Colombia
Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico
RECRUITING
Medellín
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Estonia
Astra Kliinik
RECRUITING
Tallinn
France
CHU de Bordeaux - Hôpital
RECRUITING
Bourdeaux
AP-HP - Hôpital Henri Mondor
RECRUITING
Créteil
CHU de Lille - Hôpital Roger Salengro
RECRUITING
Lille
CHU de Nice-Hôpital Pasteur
RECRUITING
Nice
AP-HP - Hôpital de la Pitié Salpétrière
RECRUITING
Paris
Georgia
First Medical Clinic LLC
RECRUITING
Batumi
High Technology Hospital MedCenter Ltd
RECRUITING
Batumi
Aleksandre Aladashvili Clinic
RECRUITING
Tbilisi
Curatio JSC
RECRUITING
Tbilisi
Geo Hospitals
RECRUITING
Tbilisi
Jo Ann Medical Center
RECRUITING
Tbilisi
LTD New Hospitals
RECRUITING
Tbilisi
Petre Sarajishvili Institute of Neurology
RECRUITING
Tbilisi
Greece
University General Hospital of Alexandroupolis
RECRUITING
Alexandroupoli
Eginitio Hospital
RECRUITING
Athens
Hungary
Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete
RECRUITING
Budapest
Israel
Hillel Yaffe Medical Center
RECRUITING
Hadera
The Chaim Sheba Medical Center - PPDS
RECRUITING
Ramat Gan
Italy
IRCCS Istituto delle Scienze Neurologiche di Bologna
RECRUITING
Bologna
IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino
RECRUITING
Genova
Fondazione Serena Onlus - Centro Clinico NeMO Brescia
RECRUITING
Gussago
Ospedale San Raffaele S.r.l.
RECRUITING
Milan
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
RECRUITING
Pavia
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara
RECRUITING
Trieste
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara
RECRUITING
Trieste
Japan
Institute of Science Tokyo Hospital
RECRUITING
Bunkyō-ku
Seirei Hamamatsu Hospital
RECRUITING
Hiroshima
Southern TOHOKU Medical Clinic
RECRUITING
Kōriyama
Saga University Hospital
RECRUITING
Saga
Netherlands
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
Poland
Centrum Medyczne Neurologia Slaska
RECRUITING
Katowice
SP ZOZ Szpital Uniwersytecki w Krakowie
RECRUITING
Krakow
Galen Clinic - Warszawa
RECRUITING
Warsaw
Republic of Korea
Korea University Guro Hospital
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Republic of Moldova
Institutul de Neurologie si Neurochirurgie
RECRUITING
Chisinau
Institutul de Neurologie si Neurochirurgie
RECRUITING
Chisinau
Romania
Regina Maria Brasov Hospital
RECRUITING
Brasov
S.C. Neurocity S.R.L
RECRUITING
Bucharest
SC Clubul Sanatatii SRL
RECRUITING
Campulung Muscel
Spitalul Judetean de Urgenta Deva
RECRUITING
Deva
Singapore
National Neuroscience Institute
RECRUITING
Singapore
Slovakia
Univerzitna nemocnica MARTIN
RECRUITING
Martin
Nemocnica s poliklinikou S. Kukuru a.s. - Pentahospitals
RECRUITING
Michalovce
Penta Hospitals SK, a.s. - Rimavská Sobota
RECRUITING
Rimavská Sobota
United Kingdom
Kent and Canterbury Hospital
RECRUITING
Canterbury
The National Hospital for Neurology and Neurosurgery - PPDS
RECRUITING
London
Queen's Medical Centre
RECRUITING
Nottingham
Salford Royal Hospital
RECRUITING
Salford
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date: 2025-09-16
Estimated Completion Date: 2031-01-23
Participants
Target number of participants: 160
Treatments
Experimental: Part A - Empasiprubart
Participants receive empasiprubart during part A
Placebo_comparator: Part A - Placebo
Participants receive placebo during part A
Experimental: Part B - Empasiprubart
Participants receive empasiprubart during part B. Participants from the empasiprubart arm in part A will receive placebo once to maintain the blind of part A.
Related Therapeutic Areas
Sponsors
Leads: argenx