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

Last updated: June 11, 2026
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

3

Condition

Peripheral Neuropathy

Treatment

empasiprubart-placebo

empasiprubart

IVIg-placebo

Clinical Study ID

NCT06920004
ARGX-117-2401
2024-520097-36-00
  • Ages > 18
  • All Genders

Study 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

Inclusion

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, multifocalCIDP (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

Exclusion Criteria:

  • Besides the indication under study, known autoimmune disease or any medicalcondition that would interfere with an accurate assessment of clinical symptoms ofCIDP 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 CIDPguidelines, second revision (2021)

  • Use of other long-acting immunomodulatory treatment

Study Design

Total Participants: 218
Treatment Group(s): 4
Primary Treatment: empasiprubart-placebo
Phase: 3
Study Start date:
August 22, 2025
Estimated Completion Date:
September 30, 2030

Connect with a study center

  • INECO Neurociencias Oroño

    Rosario, S2000DTP
    Argentina

    Active - Recruiting

  • Universitätsklinikum AKH Wien

    Vienna, 1090
    Austria

    Active - Recruiting

  • Fakultni nemocnice Brno

    Brno,
    Czechia

    Active - Recruiting

  • Astra Kliinik

    Tallinn, 11315
    Estonia

    Active - Recruiting

  • Tartu University Hospital

    Tartu, 50406
    Estonia

    Active - Recruiting

  • AP-HP - Hôpital de la Pitié Salpétrière

    Paris, Paris 75013
    France

    Site Not Available

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33076
    France

    Active - Recruiting

  • AP-HP - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270
    France

    Active - Recruiting

  • CHU de Nice-Hôpital Pasteur

    Nice, 6001
    France

    Active - Recruiting

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200
    France

    Active - Recruiting

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

    Toulouse, 31059
    France

    Active - Recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, 24105
    Germany

    Active - Recruiting

  • University General Hospital of Alexandroupolis

    Athens, 15562
    Greece

    Active - Recruiting

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

    Chaïdári, 124 62
    Greece

    Active - Recruiting

  • The Barzilai University Medical Center

    Ashkelon, 78278
    Israel

    Active - Recruiting

  • Hadassah Medical Center- Ein Kerem

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center

    Tel Litwinsky, 52621
    Israel

    Active - Recruiting

  • AUSL di Bologna - Ospedale Bellaria

    Bologna, 40139
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS

    Pavia, 27100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I

    Roma, 161
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    Roma, 00189
    Italy

    Active - Recruiting

  • Aomori Prefectural Central Hospital

    Aomori, 030-8553
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyō City, 113-8431
    Japan

    Active - Recruiting

  • Chiba University Hospital

    Chūōku, 260-8677
    Japan

    Active - Recruiting

  • Juntendo Shizuoka University Hospital

    Izunokuni, 410-2295
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586
    Japan

    Active - Recruiting

  • Saga University Hospital

    Saga, 849-8501
    Japan

    Active - Recruiting

  • General Hospital Tsuchiura Kyodo Hospital

    Tsuchiura, 300-0028
    Japan

    Active - Recruiting

  • Yamaguchi University Hospital

    Ube, 755-0067
    Japan

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • Oslo Universitetssykehus HF, Ullevål

    Oslo, 450
    Norway

    Active - Recruiting

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065
    Poland

    Active - Recruiting

  • Neurocentrum Bydgoszcz

    Bydgoszcz, 85-796
    Poland

    Active - Recruiting

  • Centrum Medyczne Neurologia Slaska

    Katowice, 40-689
    Poland

    Active - Recruiting

  • Centrum Medyczne Linden

    Krakow, 30-721
    Poland

    Active - Recruiting

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 30-688
    Poland

    Active - Recruiting

  • Galen Clinic - Lublin

    Lublin, 20-064
    Poland

    Active - Recruiting

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

    Poznan, 61-731
    Poland

    Active - Recruiting

  • Centrum Medyczne Medyk

    Rzeszów, 35-210
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 1

    Szczecin, 71-252
    Poland

    Active - Recruiting

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

    Szczecin, 71-252
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw, 02-097
    Poland

    Active - Recruiting

  • ULS de Santo António, EPE - Hospital de Santo António

    Porto, 4050-342
    Portugal

    Active - Recruiting

  • Institutul National de Neurologie si Boli Neurovasculare Bucuresti

    Bucharest, 41914
    Romania

    Active - Recruiting

  • Brainaxy Clinic SRL

    Constanța, 900348
    Romania

    Active - Recruiting

  • Targu-Mures Emergency Clinical County Hospital

    Târgu Mureş, 540136
    Romania

    Active - Recruiting

  • University Clinical Center of Serbia - Dr Subotica 6

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • University Clinical Center Nis

    Niš, 18 000
    Serbia

    Active - Recruiting

  • National Neuroscience Institute

    Singapore, 308433
    Singapore

    Active - Recruiting

  • Univerzitna nemocnica MARTIN

    Martin, 036 59
    Slovakia

    Active - Recruiting

  • University Medical Centre Ljubljana

    Ljubljana, 1000
    Slovenia

    Active - Recruiting

  • University Clinical Centre Maribor

    Maribor, 2000
    Slovenia

    Active - Recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    South Korea

    Active - Recruiting

  • Konkuk University Medical Center

    Seoul, 05030
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    South Korea

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Sant Andreu de la Barca, 08740
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009
    Spain

    Active - Recruiting

  • Sahlgrenska University Hospital

    Gothenburg, 41346
    Sweden

    Active - Recruiting

  • Hôpitaux Universitaires de Genève (HUG)

    Geneva, 1205
    Switzerland

    Active - Recruiting

  • Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi

    Samsun, 55200
    Turkey (Türkiye)

    Active - Recruiting

  • Salford Royal Hospital - PPDS

    Salford, Lancashire M6 8HD
    United Kingdom

    Site Not Available

  • Samir Macwan, M.D., Inc.

    Rancho Mirage, California 922701
    United States

    Active - Recruiting

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia 20010
    United States

    Active - Recruiting

  • Homestead Associates in Research Inc

    Homestead, Florida 33033
    United States

    Active - Recruiting

  • Visionary Investigators Network

    Miami, Florida 33133
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33616
    United States

    Active - Recruiting

  • Paradigm Health System

    Slidell, Louisiana 70458
    United States

    Active - Recruiting

  • Erlanger Health System

    Columbia, Maryland 21044
    United States

    Active - Recruiting

  • University of Michigan Hospital

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • NeuroCarePlus

    Houston, Texas 77094
    United States

    Active - Recruiting

  • National Neuromuscular Research Institute

    Irving, Texas 75063
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.