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NCT06920004PHASE3Recruiting

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

argenx

Start Date

8/22/2025

Completion Date

9/1/2030

Summary

The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart 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/emvigorate

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, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP * Has responded to IVIg in the past 5 years * Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg * Has residual disability and active disease Exclusion Criteria: * Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes * Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) * Use of other long-acting immunomodulatory treatment

Interventions

BIOLOGICAL

empasiprubart

BIOLOGICAL

IVIg

OTHER

empasiprubart-placebo

OTHER

IVIg-placebo

Interested in This Trial?

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Conditions

Chronic Inflammatory Demyelinating PolyneuropathyCIDPCIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Locations

University of Alabama

Birmingham, Alabama 35233

United States

Samir Macwan, M.D., Inc.

Rancho Mirage, California 922701

United States

Colorado Springs Neurological Associates

Colorado Springs, Colorado 80907

United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

Homestead Associates in Research Inc

Homestead, Florida 33033

United States

Visionary Investigators Network

Miami, Florida 33133

United States

University of South Florida

Tampa, Florida 33616

United States

Paradigm Health System

Slidell, Louisiana 70458

United States

Erlanger Health System

Columbia, Maryland 21044

United States

University of Michigan Hospital

Ann Arbor, Michigan 48109

United States

NeuroCarePlus

Houston, Texas 77094

United States

National Neuromuscular Research Institute

Irving, Texas 75063

United States

INECO Neurociencias Oroño

Rosario, S2000DTP

Argentina

Universitätsklinikum AKH Wien

Vienna, 1090

Austria

Hospital Universitario San Ignacio

Bogotá, 110231

Colombia

Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico

Medellín, 50012

Colombia

Fakultni nemocnice Brno

Brno,

Czechia

Astra Kliinik

Tallinn, 11315

Estonia

Tartu University Hospital

Tartu, 50406

Estonia

AP-HP - Hôpital de la Pitié Salpétrière

Paris, Paris 75013

France

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33076

France

AP-HP - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270

France

CHU de Nice-Hôpital Pasteur

Nice, 6001

France

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67200

France

CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan

Toulouse, 31059

France

Charité - Universitätsmedizin Berlin

Berlin, 13353

Germany

Universitätsklinikum Schleswig-Holstein - Campus Kiel

Kiel, 24105

Germany

University General Hospital of Alexandroupolis

Athens, 15562

Greece

University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

Chaïdári, 124 62

Greece

Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete

Budapest, 1085

Hungary

The Barzilai University Medical Center

Ashkelon, 78278

Israel

Hadassah Medical Center- Ein Kerem

Jerusalem, 9112001

Israel

The Chaim Sheba Medical Center

Tel Litwinsky, 52621

Israel

AUSL di Bologna - Ospedale Bellaria

Bologna, 40139

Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

Pavia, 27100

Italy

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, 00189

Italy

Fondazione PTV Policlinico Tor Vergata

Roma, 133

Italy

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Roma, 161

Italy

IRCCS Istituto Clinico Humanitas

Rozzano, 20089

Italy

Aomori Prefectural Central Hospital

Aomori, 030-8553

Japan

Juntendo University Hospital

Bunkyō City, 113-8431

Japan

Chiba University Hospital

Chūōku, 260-8677

Japan

Juntendo Shizuoka University Hospital

Izunokuni, 410-2295

Japan

Osaka Metropolitan University Hospital

Osaka, 545-8586

Japan

Saga University Hospital

Saga, 849-8501

Japan

General Hospital Tsuchiura Kyodo Hospital

Tsuchiura, 300-0028

Japan

Yamaguchi University Hospital

Ube, 755-0067

Japan

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX

Netherlands

Oslo Universitetssykehus HF, Ullevål

Oslo, 450

Norway

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, 85-065

Poland

Neurocentrum Bydgoszcz

Bydgoszcz, 85-796

Poland

Centrum Medyczne Neurologia Slaska

Katowice, 40-689

Poland

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, 30-688

Poland

Centrum Medyczne Linden

Krakow, 30-721

Poland

Galen Clinic - Lublin

Lublin, 20-064

Poland

Clinical Research Center Sp. z o.o. Medic-R sp.k.

Poznan, 61-731

Poland

Centrum Medyczne Medyk

Rzeszów, 35-210

Poland

Uniwersytecki Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie

Szczecin, 71-252

Poland

Uniwersytecki Szpital Kliniczny Nr 1

Szczecin, 71-252

Poland

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, 02-097

Poland

ULS de Santo António, EPE - Hospital de Santo António

Porto, 4050-342

Portugal

Institutul National de Neurologie si Boli Neurovasculare Bucuresti

Bucharest, 41914

Romania

Brainaxy Clinic SRL

Constanța, 900348

Romania

Targu-Mures Emergency Clinical County Hospital

Târgu Mureş, 540136

Romania

University Clinical Center of Serbia - Dr Subotica 6

Belgrade, 11000

Serbia

University Clinical Center Nis

Niš, 18 000

Serbia

National Neuroscience Institute

Singapore, 308433

Singapore

Univerzitna nemocnica MARTIN

Martin, 036 59

Slovakia

University Medical Centre Ljubljana

Ljubljana, 1000

Slovenia

University Clinical Centre Maribor

Maribor, 2000

Slovenia

Inje University Haeundae Paik Hospital

Busan, 48108

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Konkuk University Medical Center

Seoul, 05030

South Korea

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Hospital Universitario Vall d'Hebron

Sant Andreu de la Barca, 08740

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Sahlgrenska University Hospital

Gothenburg, 41346

Sweden

Hôpitaux Universitaires de Genève (HUG)

Geneva, 1205

Switzerland

Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi

Samsun, 55200

Turkey (Türkiye)

Salford Royal Hospital - PPDS

Salford, Lancashire M6 8HD

United Kingdom

The National Hospital for Neurology and Neurosurgery - PPDS

London, WC1N 3BG

United Kingdom