Back to Trials
NCT07091630PHASE3Recruiting

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

argenx

Start Date

9/16/2025

Completion Date

1/23/2031

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Exclusion Criteria: * Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) * Sensory CIDP (including sensory-predominant CIDP) * Polyneuropathy of other causes * Clinical diagnosis of systemic lupus erythematosus (SLE) * Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation

Interventions

BIOLOGICAL

Empasiprubart IV

OTHER

Placebo IV

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Chronic Inflammatory Demyelinating PolyneuropathyCIDPChronic Inflammatory Demyelinating Polyradiculoneuropathy

Locations

University of Alabama at Birmingham - 1720 University Blvd

Birmingham, Alabama 35233

United States

Samir Macwan, M.D., Inc. (S corporation)

Rancho Mirage, California 92270

United States

Colorado Springs Neurological Associates

Colorado Springs, Colorado 80907

United States

Medstar Health Research Institute

Washington D.C., District of Columbia 20010

United States

Gables Neurology

Miami, Florida 33133

United States

Aqualane Clinical Research

Naples, Florida 34105

United States

Paradigm Health System

Slidell, Louisiana 70458

United States

Penn Medicine University City

Philadelphia, Pennsylvania 19104-5545

United States

National Neuromuscular Research Institute

Austin, Texas 78756

United States

NeuroCarePlus

Houston, Texas 77094

United States

Instituto Privado Kremer

Córdoba, X5004AOA

Argentina

Instituto Médico de la Fundación Estudios Clínicos

Rosario, S2000DEJ

Argentina

INECO Neurociencias Oroño

Rosario,

Argentina

Kepler Universitätsklinikum Linz - Med Campus III

Linz, Upper Austria 4021

Austria

Universitätsklinikum AKH Wien

Vienna, 1090

Austria

PSEG Centro de Pesquisa Clinica

São Paulo, 04038-002

Brazil

Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD

Sofia, Sofia 1113

Bulgaria

University Multiprofile Hospital for Active Treatment

Pleven, 5803

Bulgaria

Medical Center Medika 2005 - Branch Sofia

Sofia, 1164

Bulgaria

University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

Sofia, 1431

Bulgaria

University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

Sofia, 1606

Bulgaria

Fujian Medical University Union Hospital - Yushan Campus

Fuzhou, Fujian 350108

China

Peking University First Hospital - Changqiao Campus

Beijing, 100034

China

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, 510120

China

Nanfang Hospital Southern Medical University

Guangzhou, 510515

China

Xi'an Gaoxin Hospital

Xi'an, 710075

China

Fakultni nemocnice Brno

Brno, 625 00

Czechia

Rigshospitalet

Copenhagen, 2100

Denmark

Astra Kliinik

Tallinn, 11315

Estonia

CHU de Lille - Hôpital Roger Salengro

Lille, Nord 59000

France

AP-HP - Hôpital de la Pitié Salpétrière

Paris, Paris 75013

France

AP-HP - Hôpital Henri Mondor

Créteil, Val-de-Marne 94000

France

CHU de Bordeaux - Hôpital

Bourdeaux,

France

CHU de Nice-Hôpital Pasteur

Nice, 6001

France

High Technology Hospital MedCenter Ltd

Batumi, 6000

Georgia

First Medical Clinic LLC

Batumi,

Georgia

Petre Sarajishvili Institute of Neurology

Tbilisi, 0112

Georgia

Aleksandre Aladashvili Clinic

Tbilisi, 102

Georgia

Curatio JSC

Tbilisi, 114

Georgia

LTD New Hospitals

Tbilisi, 114

Georgia

Geo Hospitals

Tbilisi, 144

Georgia

Jo Ann Medical Center

Tbilisi, 159

Georgia

University General Hospital of Alexandroupolis

Alexandroupoli, Evros 68100

Greece

Eginitio Hospital

Athens,

Greece

Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete

Budapest, 1082

Hungary

Fondazione Serena Onlus - Centro Clinico NeMO Brescia

Gussago, Brescia 25064

Italy

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

Trieste, Friuli-VeneziaGiulia 34149

Italy

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, 40139

Italy

IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino

Genova, 16132

Italy

Ospedale San Raffaele S.r.l.

Milan, 20132

Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, 27100

Italy

Institute of Science Tokyo Hospital

Bunkyō-Ku, Tokyo 113-8519

Japan

Seirei Hamamatsu Hospital

Hiroshima, 430-8558

Japan

Southern TOHOKU Medical Clinic

Kōriyama, 963-8052

Japan

Saga University Hospital

Saga, 849-0937

Japan

Institutul de Neurologie si Neurochirurgie

Chisinau, 2028

Moldova

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX

Netherlands

Centrum Medyczne Neurologia Slaska

Katowice, 40-689

Poland

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, 30-688

Poland

Galen Clinic - Warszawa

Warsaw,

Poland

S.C. Neurocity S.R.L

Bucharest,

Romania

SC Clubul Sanatatii SRL

Campulung Muscel, 115100

Romania

Spitalul Judetean de Urgenta Deva

Deva, 330084

Romania

National Neuroscience Institute

Singapore,

Singapore

Univerzitna nemocnica MARTIN

Martin, 036 59

Slovakia

Nemocnica s poliklinikou S. Kukuru a.s. - Pentahospitals

Michalovce, 071 01

Slovakia

Penta Hospitals SK, a.s. - Rimavská Sobota

Rimavská Sobota, 979 01

Slovakia

Seoul National University Hospital

Seoul, 03080

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

The National Hospital for Neurology and Neurosurgery - PPDS

London, WC1N3BG

United Kingdom

Salford Royal Hospital

Salford, M6 8HD

United Kingdom