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A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Sponsor: argenx
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
Official title: A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-09-16
Completion Date
2031-01-23
Last Updated
2026-05-28
Healthy Volunteers
No
Conditions
Interventions
Empasiprubart IV
Intravenous infusion of empasiprubart
Placebo IV
Intravenous infusion of placebo
Locations (56)
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, California, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Medstar Health Research Institute
Washington D.C., District of Columbia, United States
Gables Neurology
Miami, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Paradigm Health System
Slidell, Louisiana, United States
Penn Medicine University City
Philadelphia, Pennsylvania, United States
National Neuromuscular Research Institute
Austin, Texas, United States
NeuroCarePlus
Houston, Texas, United States
Kepler Universitätsklinikum Linz - Med Campus III
Linz, Upper Austria, Austria
Universitätsklinikum AKH Wien
Vienna, Austria
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
Sofia, Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment
Pleven, Bulgaria
Medical Center Medika 2005 - Branch Sofia
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
Sofia, Bulgaria
Fujian Medical University Union Hospital - Yushan Campus
Fuzhou, Fujian, China
Peking University First Hospital - Changqiao Campus
Beijing, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, China
Nanfang Hospital Southern Medical University
Guangzhou, China
Xi'an Gaoxin Hospital
Xi'an, China
Fakultni nemocnice Brno
Brno, Czechia
Rigshospitalet
Copenhagen, Denmark
Astra Kliinik
Tallinn, Estonia
CHU de Bordeaux - Hôpital
Bourdeaux, France
High Technology Hospital MedCenter Ltd
Batumi, Georgia
First Medical Clinic LLC
Batumi, Georgia
Petre Sarajishvili Institute of Neurology
Tbilisi, Georgia
Aleksandre Aladashvili Clinic
Tbilisi, Georgia
Curatio JSC
Tbilisi, Georgia
LTD New Hospitals
Tbilisi, Georgia
Geo Hospitals
Tbilisi, Georgia
Jo Ann Medical Center
Tbilisi, Georgia
University General Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece
Fondazione Serena Onlus - Centro Clinico NeMO Brescia
Gussago, Brescia, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara
Trieste, Friuli-VeneziaGiulia, Italy
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, Italy
Institute of Science Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
Seirei Hamamatsu Hospital
Hiroshima, Japan
Southern TOHOKU Medical Clinic
Kōriyama, Japan
Saga University Hospital
Saga, Japan
Institutul de Neurologie si Neurochirurgie
Chisinau, Moldova
Centrum Medyczne Neurologia Slaska
Katowice, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland
Galen Clinic - Warszawa
Warsaw, Poland
S.C. Neurocity S.R.L
Bucharest, Romania
SC Clubul Sanatatii SRL
Campulung Muscel, Romania
Spitalul Judetean de Urgenta Deva
Deva, Romania
National Neuroscience Institute
Singapore, Singapore
Univerzitna nemocnica MARTIN
Martin, Slovakia
Nemocnica s poliklinikou S. Kukuru a.s. - Pentahospitals
Michalovce, Slovakia
Penta Hospitals SK, a.s. - Rimavská Sobota
Rimavská Sobota, Slovakia
Seoul National University Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
The National Hospital for Neurology and Neurosurgery - PPDS
London, United Kingdom