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 (60) 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
ACTIVE_NOT_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
Louisiana
Paradigm Health System
RECRUITING
Slidell
Pennsylvania
Penn Medicine University City
RECRUITING
Philadelphia
Texas
National Neuromuscular Research Institute
RECRUITING
Austin
NeuroCarePlus
RECRUITING
Houston
Other Locations
Argentina
INECO Neurociencias Oroño
ACTIVE_NOT_RECRUITING
Rosario
Austria
Kepler Universitätsklinikum Linz - Med Campus III
ACTIVE_NOT_RECRUITING
Linz
Universitätsklinikum AKH Wien
RECRUITING
Vienna
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
ACTIVE_NOT_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
ACTIVE_NOT_RECRUITING
Fuzhou
Guangdong Provincial Hospital of Chinese Medicine
RECRUITING
Guangzhou
Nanfang Hospital Southern Medical University
RECRUITING
Guangzhou
Xi'an Gaoxin Hospital
RECRUITING
Xi'an
Denmark
Rigshospitalet
ACTIVE_NOT_RECRUITING
Copenhagen
Estonia
Astra Kliinik
RECRUITING
Tallinn
France
CHU de Bordeaux - Hôpital
NOT_YET_RECRUITING
Bourdeaux
AP-HP - Hôpital Henri Mondor
ACTIVE_NOT_RECRUITING
Créteil
CHU de Lille - Hôpital Roger Salengro
ACTIVE_NOT_RECRUITING
Lille
AP-HP - Hôpital de la Pitié Salpétrière
ACTIVE_NOT_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
ACTIVE_NOT_RECRUITING
Alexandroupoli
Italy
IRCCS Istituto delle Scienze Neurologiche di Bologna
RECRUITING
Bologna
Fondazione Serena Onlus - Centro Clinico NeMO Brescia
ACTIVE_NOT_RECRUITING
Gussago
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
RECRUITING
Pavia
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara
ACTIVE_NOT_RECRUITING
Trieste
Japan
Institute of Science Tokyo Hospital
ACTIVE_NOT_RECRUITING
Bunkyō-ku
Seirei Hamamatsu Hospital
RECRUITING
Hiroshima
Southern TOHOKU Medical Clinic
RECRUITING
Kōriyama
Saga University Hospital
RECRUITING
Saga
Poland
Centrum Medyczne Neurologia Slaska
RECRUITING
Katowice
SP ZOZ Szpital Uniwersytecki w Krakowie
RECRUITING
Krakow
Galen Clinic - Warszawa
ACTIVE_NOT_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
ACTIVE_NOT_RECRUITING
Chisinau
Romania
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
ACTIVE_NOT_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
The National Hospital for Neurology and Neurosurgery - PPDS
ACTIVE_NOT_RECRUITING
London
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