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RECRUITING
NCT06920004
PHASE3

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

Sponsor: argenx

View on ClinicalTrials.gov

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

Official title: A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

218

Start Date

2025-08-22

Completion Date

2030-09

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

empasiprubart

Intravenous infusion of empasiprubart

BIOLOGICAL

IVIg

Intravenous infusion of IVIg

OTHER

empasiprubart-placebo

A placebo resembling the empasiprubart treatment

OTHER

IVIg-placebo

A placebo resembling the IVIg treatment

Locations (46)

Colorado Springs Neurological Associates

Colorado Springs, Colorado, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Homestead Associates in Research Inc

Homestead, Florida, United States

Visionary Investigators Network

Miami, Florida, United States

Paradigm Health System

Slidell, Louisiana, United States

Erlanger Health System

Columbia, Maryland, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

NeuroCarePlus

Houston, Texas, United States

National Neuromuscular Research Institute

Irving, Texas, United States

Fakultni nemocnice Brno

Brno, Czechia

Astra Kliinik

Tallinn, Estonia

Tartu University Hospital

Tartu, Estonia

Charité - Universitätsmedizin Berlin

Berlin, Germany

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

Chaïdári, Greece

The Barzilai University Medical Center

Ashkelon, Israel

Hadassah Medical Center- Ein Kerem

Jerusalem, Israel

The Chaim Sheba Medical Center

Tel Litwinsky, Israel

AUSL di Bologna - Ospedale Bellaria

Bologna, Italy

Aomori Prefectural Central Hospital

Aomori, Japan

Juntendo University Hospital

Bunkyō City, Japan

Chiba University Hospital

Chūōku, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Saga University Hospital

Saga, Japan

General Hospital Tsuchiura Kyodo Hospital

Tsuchiura, Japan

Yamaguchi University Hospital

Ube, Japan

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland

Neurocentrum Bydgoszcz

Bydgoszcz, Poland

Centrum Medyczne Neurologia Slaska

Katowice, Poland

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, Poland

Centrum Medyczne Linden

Krakow, Poland

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

Poznan, Poland

Centrum Medyczne Medyk

Rzeszów, Poland

Uniwersytecki Szpital Kliniczny Nr 1

Szczecin, Poland

ULS de Santo António, EPE - Hospital de Santo António

Porto, Portugal

Institutul National de Neurologie si Boli Neurovasculare Bucuresti

Bucharest, Romania

Brainaxy Clinic SRL

Constanța, Romania

Targu-Mures Emergency Clinical County Hospital

Târgu Mureş, Romania

Univerzitna nemocnica MARTIN

Martin, Slovakia

Inje University Haeundae Paik Hospital

Busan, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Konkuk University Medical Center

Seoul, South Korea

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario Vall d'Hebron

Sant Andreu de la Barca, Spain

Hôpitaux Universitaires de Genève (HUG)

Geneva, Switzerland