RecruitingPhase 3NCT07091630

A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

Sponsor

argenx

Enrollment

160 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy Chronic Inflammatory Demyelinating Polyradiculoneuropathy CIDP

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Empasiprubart IV and Placebo IV for people with cidp, chronic inflammatory demyelinating polyneuropathy, and other related conditions. The study is currently recruiting participants at 71 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEmpasiprubart IV

Intravenous infusion of empasiprubart

OTHERPlacebo IV

Intravenous infusion of placebo

Locations(78)

University of Alabama at Birmingham - 1720 University Blvd

Birmingham, Alabama, United States

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

Jefferson Health Honickman Center

Philadelphia, Pennsylvania, United States

National Neuromuscular Research Institute

Austin, Texas, United States

NeuroCarePlus

Houston, Texas, United States

Instituto Privado Kremer

Córdoba, Argentina

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Argentina

INECO Neurociencias Oroño

Rosario, Argentina

Kepler Universitätsklinikum Linz - Med Campus III

Linz, Upper Austria, Austria

Universitätsklinikum AKH Wien

Vienna, Austria

L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

Brasília, Brazil

Hospital Moinhos de Vento

Porto Alegre, Brazil

PSEG Centro de Pesquisa Clinica

São Paulo, Brazil

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 Lille - Hôpital Roger Salengro

Lille, Nord, France

AP-HP - Hôpital de la Pitié Salpétrière

Paris, Paris, France

AP-HP - Hôpital Henri Mondor

Créteil, Val-de-Marne, France

CHU de Bordeaux - Hôpital

Bourdeaux, France

CHU de Nice-Hôpital Pasteur

Nice, 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

Eginitio Hospital

Athens, Greece

Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete

Budapest, Hungary

Hillel Yaffe Medical Center

Hadera, Israel

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

IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino

Genova, Italy

Ospedale San Raffaele S.r.l.

Milan, Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, Italy

Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara

Trieste, 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

Institutul de Neurologie si Neurochirurgie

Chisinau, Moldova

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Centrum Medyczne Neurologia Slaska

Katowice, Poland

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, Poland

Galen Clinic - Warszawa

Warsaw, Poland

Regina Maria Brasov Hospital

Brasov, Romania

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

Salford Royal Hospital

Salford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07091630

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