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NCT06920004RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
218 (estimated)
First submitted
26 Mar 2025
Start date
22 Aug 2025
Primary completion date
30 Sept 2027
Lead sponsor
argenx
NCT number
NCT06920004
EU CT number
2024-520097-36-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 218
  • From 22 Aug 2025 to the primary completion date, 30 Sept 2027
  • 113 sites in 33 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (113)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Privado Kremer
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CórdobaArgentinaRecruiting
INECO Neurociencias Oroño
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RosarioArgentinaRecruiting
Kepler Universitaetsklinikum GmbH
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LinzAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Liverpool Hospital
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LiverpoolAustraliaRecruiting
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
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PlevenBulgariaCompleted
Alexandrovska University Hospital
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SofiaBulgariaCompleted
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaCompleted
Escola Bahiana de Medicina e Saude Publica
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SalvadorBrazilRecruiting
PSEG Centro de Pesquisa Clinica
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São PauloBrazilRecruiting
PSEG Centro de Pesquisa Clinica - Rua Borges Lagoa 1060
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São PauloBrazilRecruiting
University Of Calgary
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CalgaryCanadaRecruiting
University of Alberta
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EdmontonCanadaRecruiting
Black Tusk Research Group
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VancouverCanadaRecruiting
Hôpitaux Universitaires de Genève (HUG)
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GenevaSwitzerlandRecruiting
Hospital Universitario San Ignacio
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BogotáColombiaRecruiting
Hospital Alma Mater de Antioquia
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MedellínColombiaRecruiting
Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico
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MedellínColombiaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyRecruiting
Rigshospitalet
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Copenhagen OeDenmarkRecruiting
Clinic4U OÜ
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TallinnEstoniaRecruiting
Tartu University Hospital
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Tartu LinnEstoniaRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceRecruiting
Bicetre Hospital
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Le Kremlin Bicetre CedexFranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceRecruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceRecruiting
Leeds General Infirmary
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LeedsUnited KingdomRecruiting
The National Hospital for Neurology and Neurosurgery - PPDS
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LondonUnited KingdomRecruiting
Salford Royal Hospital - PPDS
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SalfordUnited KingdomRecruiting
University General Hospital of Alexandroupoli
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AlexandroupoliGreeceRecruiting
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
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AthensGreeceRecruiting
Clinexpert Kft.
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Budapest IIIHungaryRecruiting
Semmelweis University
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Budapest VIIIHungaryRecruiting
The Barzilai University Medical Center
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AshkelonIsraelRecruiting
Hadassah Medical Center - Ein Kerem
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JerusalemIsraelRecruiting
The Chaim Sheba Medical Center
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Tel-HashomerIsraelRecruiting
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyRecruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyRecruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyRecruiting
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyRecruiting
Aomori Prefectural Central Hospital
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AomoriJapanRecruiting
Juntendo University Hospital
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Bunkyō CityJapanRecruiting
Chiba University Hospital
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ChūōkuJapanRecruiting
Seirei Hamamatsu Hospital
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HiroshimaJapanRecruiting
Juntendo Shizuoka University Hospital
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IzunokuniJapanRecruiting
Osaka Metropolitan University Hospital
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OsakaJapanRecruiting
Saga University Hospital
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SagaJapanRecruiting
Jichi Medical University Hospital
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ShimotsukeJapanRecruiting
General Hospital Tsuchiura Kyodo Hospital
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TsuchiuraJapanRecruiting
Yamaguchi University Hospital
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UbeJapanRecruiting
Inje University Haeundae Paik Hospital
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BusanSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Konkuk University Medical Center
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SeoulSouth KoreaRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsRecruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Medicover Integrated Clinical Services Sp. z o.o.
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BydgoszczPolandRecruiting
Neurocentrum Bydgoszcz sp. z o.o
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BydgoszczPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandRecruiting
Linden Sp. z o.o. sp.k.
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CracowPolandRecruiting
Neurologia Śląska Centrum Medyczne
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KatowicePolandRecruiting
Galen Clinic
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LublinPolandRecruiting
Clinical Research Center Sp z o o Medic R Sp k
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PoznanPolandRecruiting
Centrum Medyczne Medyk Sp. z o.o. S.K.
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RzeszowPolandRecruiting
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
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SzczecinPolandRecruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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WarsawPolandRecruiting
Galen Clinic
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WarszawaPolandRecruiting
Unidade Local De Saude De Santo Antonio E.P.E.
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PortoPortugalRecruiting
Institutul National de Neurologie si Boli Neurovasculare Bucuresti
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BucharestRomaniaRecruiting
Brainaxy Clinic S.R.L.
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ConstantaRomaniaRecruiting
Spitalul Clinic Judetean de Urgenta Targu Mures
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Târgu MureşRomaniaRecruiting
University Clinical Center of Serbia - Dr Subotica 6
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BelgradeSerbiaRecruiting
University Clinical Center NIS
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NišSerbiaRecruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenRecruiting
National Neuroscience Institute
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SingaporeSingaporeRecruiting
University Medical Center Ljubljana
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LjubljanaSloveniaRecruiting
Univerzitetni klinični center Maribor
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MariborSloveniaRecruiting
Univerzitna nemocnica Martin
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MartinSlovakiaRecruiting
University of Michigan Hospital
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Ann ArborUnited StatesRecruiting
University of Alabama
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BirminghamUnited StatesRecruiting
University of Cincinnati Health
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CincinnatiUnited StatesRecruiting
Colorado Springs Neurological Associates
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Colorado SpringsUnited StatesRecruiting
Erlanger Health System
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ColumbiaUnited StatesRecruiting
Homestead Associates in Research Inc
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HomesteadUnited StatesRecruiting
NeuroCarePlus
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HoustonUnited StatesRecruiting
National Neuromuscular Research Institute
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IrvingUnited StatesRecruiting
University Neurology
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KnoxvilleUnited StatesRecruiting
Visionary Investigators Network
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MiamiUnited StatesRecruiting
Baptist Health Medical Group Neurology
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NicholasvilleUnited StatesRecruiting
Jefferson Health Honickman Center
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PhiladelphiaUnited StatesRecruiting
Perelman Center for Advanced Medicine
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PhiladelphiaUnited StatesRecruiting
Samir Macwan, M.D., Inc.
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Rancho MirageUnited StatesRecruiting
Paradigm Health System
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SlidellUnited StatesRecruiting
University of South Florida
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TampaUnited StatesRecruiting
Banner University of Arizona Medical Center
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TucsonUnited StatesRecruiting
MedStar Washington Hospital Center
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Washington D.C.United StatesRecruiting
Istanbul Tip Fakultesi Hastanesi (Istanbul Universitesi)
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IstanbulTurkey (Türkiye)Recruiting
Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
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SamsunTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.