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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: argenx • ClinicalTrials.gov ID: NCT06920004

Registry updated: 2026-10-16
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Description

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

Interventions

  • empasiprubart (Biological)
    Intravenous infusion of empasiprubart
  • IVIg (Biological)
    Intravenous infusion of IVIg
  • empasiprubart-placebo (Other)
    A placebo resembling the empasiprubart treatment
  • IVIg-placebo (Other)
    A placebo resembling the IVIg treatment

Eligibility criteria

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

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy CIDP CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Locations

  • University of Alabama — Birmingham, Alabama, United States
  • Samir Macwan, M.D., Inc. — Rancho Mirage, California, United States
  • 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
  • University of South Florida — Tampa, Florida, United States
  • Baptist Health Medical Group Neurology — Nicholasville, Kentucky, 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 Cincinnati Health — Cincinnati, Ohio, United States
  • Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
  • Jefferson Health Honickman Center — Philadelphia, Pennsylvania, United States
  • NeuroCarePlus — Houston, Texas, United States
  • National Neuromuscular Research Institute — Irving, Texas, United States
  • Instituto Privado Kremer — Córdoba, Argentina
  • INECO Neurociencias Oroño — Rosario, Argentina
  • Liverpool Hospital — Liverpool, New South Wales, Australia
  • Kepler Universitätsklinikum Linz - Med Campus III — Linz, Austria
  • Universitätsklinikum AKH Wien — Vienna, Austria
  • PSEG Centro de Pesquisa Clinica - Rua Borges Lagoa 1060 — São Paulo, São Paulo, Brazil
  • PSEG Centro de Pesquisa Clinica — São Paulo, Brazil
  • University of Calgary — Calgary, Alberta, Canada
  • Black Tusk Research Group — Vancouver, British Columbia, Canada
  • Hospital Universitario San Ignacio — Bogotá, Colombia
  • Hospital Alma Máter de Antioquia — Medellín, Colombia
  • Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico — Medellín, Colombia
  • Fakultni nemocnice Brno — Brno, Czechia
  • Astra Kliinik — Tallinn, Estonia
  • Tartu University Hospital — Tartu, Estonia
  • AP-HM- Hôpital de La Timone — Marseille, Bouches-du-Rhone, France
  • AP-HP - Hôpital de la Pitié Salpétrière — Paris, Paris, France
  • CHU de Bordeaux - Hôpital Pellegrin — Bordeaux, France
  • AP-HP - Hôpital Bicêtre — Le Kremlin-Bicêtre, France
  • CHU de Nice-Hôpital Pasteur — Nice, France
  • CHU de Strasbourg - Hôpital de Hautepierre — Strasbourg, France
  • CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan — Toulouse, France
  • Charité - Universitätsmedizin Berlin — Berlin, Germany
  • Universitätsklinikum Schleswig-Holstein - Campus Kiel — Kiel, Germany
  • University General Hospital of Alexandroupolis — Athens, Greece
  • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA — Chaïdári, Greece
  • Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete — Budapest, Hungary
  • 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, Emilia-Romagna, Italy
  • AUSL di Bologna - Ospedale Bellaria — Bologna, Italy
  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS — Pavia, Italy
  • Azienda Ospedaliero-Universitaria Sant'Andrea — Roma, Italy
  • Fondazione PTV Policlinico Tor Vergata — Roma, Italy
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I — Roma, Italy
  • IRCCS Istituto Clinico Humanitas — Rozzano, Italy
  • Aomori Prefectural Central Hospital — Aomori, Japan
  • Juntendo University Hospital — Bunkyō City, Japan
  • Chiba University Hospital — Chūōku, Japan
  • Seirei Hamamatsu Hospital — Hiroshima, Japan
  • Juntendo Shizuoka University Hospital — Izunokuni, Japan
  • Osaka Metropolitan University Hospital — Osaka, Japan
  • Saga University Hospital — Saga, Japan
  • Jichi Medical University Hospital — Shimotsuke, Japan
  • General Hospital Tsuchiura Kyodo Hospital — Tsuchiura, Japan
  • Yamaguchi University Hospital — Ube, Japan
  • Universitair Medisch Centrum Utrecht — Utrecht, Netherlands
  • Oslo Universitetssykehus HF, Ullevål — Oslo, Norway
  • 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
  • Galen Clinic - Lublin — Lublin, Poland
  • Clinical Research Center Sp. z o.o. Medic-R sp.k. — Poznan, Poland
  • Centrum Medyczne Medyk-al. Tadeusza Rejtana 53 — Rzeszów, Poland
  • Centrum Medyczne Medyk — Rzeszów, Poland
  • Uniwersytecki Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie — Szczecin, Poland
  • Uniwersytecki Szpital Kliniczny Nr 1 — Szczecin, Poland
  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego — Warsaw, Poland
  • ULS de Santo António, EPE - Hospital de Santo António — Porto, Portugal
  • Institutul National de Neurologie si Boli Neuroavasculare Bucuresti — Bucharest, Bucharest, Romania
  • Institutul National de Neurologie si Boli Neurovasculare Bucuresti — Bucharest, Romania
  • Brainaxy Clinic SRL — Constanța, Romania
  • Targu-Mures Emergency Clinical County Hospital — Târgu Mureş, Romania
  • University Clinical Center of Serbia - Dr Subotica 6 — Belgrade, Serbia
  • University Clinical Center Nis — Niš, Serbia
  • National Neuroscience Institute — Singapore, Singapore
  • Univerzitna nemocnica MARTIN — Martin, Slovakia
  • University Medical Centre Ljubljana — Ljubljana, Slovenia
  • University Clinical Centre Maribor — Maribor, Slovenia
  • 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 de La Santa Creu i Sant Pau — Barcelona, Spain
  • Hospital General Universitario Gregorio Marañon — Madrid, Spain
  • Hospital Universitario Vall d'Hebron — Sant Andreu de la Barca, Spain
  • Hospital Universitario Virgen Macarena — Seville, Spain
  • Sahlgrenska University Hospital — Gothenburg, Sweden
  • Hôpitaux Universitaires de Genève (HUG) — Geneva, Switzerland
  • Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi — Samsun, Turkey (Türkiye)
  • Salford Royal Hospital - PPDS — Salford, Lancashire, United Kingdom
  • Leeds General Infirmary — Leeds, United Kingdom
  • The National Hospital for Neurology and Neurosurgery - PPDS — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record