Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

En studie for å vurdere effekt og sikkerhet for Empasiprubart versus IVIG hos voksne med CIDP (emvigorate)

2. november 2026 oppdatert av: argenx

En fase 3, randomisert, dobbeltblindet, dobbelt-dummy studie som evaluerer effektiviteten og sikkerheten til intravenøs empasiprubart versus intravenøs immunoglobulin hos voksne med kronisk inflammatorisk demyeliniserende polyneuropati

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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

218

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Sabine Coppieters, MD
Telefonnummer: 857-350-4834
E-post: clinicaltrials@argenx.com

Studiesteder

Argentina
- - Córdoba, Argentina, X5004AOA
    - Rekruttering
    - Instituto Privado Kremer
    - Ta kontakt med:
      
      Carlos Deabato, MD
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
  - Rosario, Argentina, S2000DTP
    - Rekruttering
    - INECO Neurociencias Oroño
    - Ta kontakt med:
      
      Darío Tavolini, MD
      
      Telefonnummer: +5493420000000
      
      E-post: dtavolini@inecoorono.org
Australia
- New South Wales
  - Liverpool, New South Wales, Australia, 2179
    - Rekruttering
    - Liverpool Hospital
    - Ta kontakt med:
      
      Cecilia Cappelen-Smith, MD
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
Brasil
- - Salvador, Brasil, 40290-000
    - Rekruttering
    - Escola Bahiana de Medicina e Saude Publica
    - Ta kontakt med:
      
      Marcela Costa, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: ClinicalTrials@argenx.com
  - São Paulo, Brasil, 04038-002
    - Rekruttering
    - PSEG Centro de Pesquisa Clinica
    - Ta kontakt med:
      
      Paulo Sgobbi de Souza, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: clinicaltrials@argenx.com
- São Paulo
  - São Paulo, São Paulo, Brasil, 04038-002
    - Rekruttering
    - PSEG Centro de Pesquisa Clinica - Rua Borges Lagoa 1060
    - Ta kontakt med:
      
      Paulo Sgobbi de Souza
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
Canada
- - Edmonton, Canada, T6G 2G3
    - Rekruttering
    - University of Alberta
    - Ta kontakt med:
      
      Grayson Beecher, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: ClinicalTrials@argenx.com
- Alberta
  - Calgary, Alberta, Canada, T2N 1N4
    - Rekruttering
    - University of Calgary
    - Ta kontakt med:
      
      Theodore Mobach
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
- British Columbia
  - Vancouver, British Columbia, Canada, V6Z2C7
    - Rekruttering
    - Black Tusk Research Group
    - Ta kontakt med:
      
      Katherine Beadon, MD
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
Colombia
- - Bogotá, Colombia, 110231
    - Rekruttering
    - Hospital Universitario San Ignacio
    - Ta kontakt med:
      
      Alba Lucia Marentes Cubillos, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: clinicaltrials@argenx.com
  - Medellín, Colombia, 50012
    - Rekruttering
    - Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico
    - Ta kontakt med:
      
      Lina Maria Agudelo Ramos, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: clinicaltrials@argenx.com
  - Medellín, Colombia, 50012
    - Rekruttering
    - Hospital Alma Máter de Antioquia
    - Ta kontakt med:
      
      Juan Gomez, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: clinicaltrials@argenx.com
Estland
- - Tallinn, Estland, 11315
    - Rekruttering
    - Astra Kliinik
    - Ta kontakt med:
      
      Katrin Gross-Paju, MD
      
      Telefonnummer: +37253323052
      
      E-post: katrin.gross-paju@astrakliinik.ee
  - Tartu, Estland, 50406
    - Rekruttering
    - Tartu University Hospital
    - Ta kontakt med:
      
      Liis Väli, MD
      
      Telefonnummer: +3727318543
      
      E-post: Liis.Vali@kliinikum.ee
Forente stater
- Alabama
  - Birmingham, Alabama, Forente stater, 35233
    - Rekruttering
    - University of Alabama
    - Ta kontakt med:
      
      Eroboghene Ubogu, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: ubogu@uab.edu
- Arizona
  - Tucson, Arizona, Forente stater, 85719-4330
    - Rekruttering
    - Banner University of Arizona Medical Center
    - Ta kontakt med:
      
      Firas Kaddouh, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: ClinicalTrials@argenx.com
- California
  - Rancho Mirage, California, Forente stater, 922701
    - Rekruttering
    - Samir Macwan, M.D., Inc.
    - Ta kontakt med:
      
      Samir Macwan, MD
      
      Telefonnummer: 760-531-4068
      
      E-post: samirmacwan@gmail.com
- Colorado
  - Colorado Springs, Colorado, Forente stater, 80907
    - Rekruttering
    - Colorado Springs Neurological Associates
    - Ta kontakt med:
      
      David Stevens, MD
      
      Telefonnummer: 719-473-3272
      
      E-post: dstevens@csneuro.com
- District of Columbia
  - Washington D.C., District of Columbia, Forente stater, 20010
    - Rekruttering
    - MedStar Washington Hospital Center
    - Ta kontakt med:
      
      Yasir Al-Khalili, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: clinicaltrials@argenx.com
- Florida
  - Homestead, Florida, Forente stater, 33033
    - Rekruttering
    - Homestead Associates in Research Inc
    - Ta kontakt med:
      
      Christopher Jimenez, MD
      
      Telefonnummer: 305-246-0873
      
      E-post: cjimenez@associatesinresearch.com
  - Miami, Florida, Forente stater, 33133
    - Rekruttering
    - Visionary Investigators Network
    - Ta kontakt med:
      
      Andrew Lerman, MD
      
      Telefonnummer: 786-655-8010
      
      E-post: alerman@fcneurology.net
  - Tampa, Florida, Forente stater, 33616
    - Rekruttering
    - University of South Florida
    - Ta kontakt med:
      
      Kathleen Murray, MD
      
      Telefonnummer: 813-974-9713
      
      E-post: kmurray11@usf.edu
- Kentucky
  - Nicholasville, Kentucky, Forente stater, 40356-6066
    - Rekruttering
    - Baptist Health Medical Group Neurology
    - Ta kontakt med:
      
      James Winkley
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
- Louisiana
  - Slidell, Louisiana, Forente stater, 70458
    - Rekruttering
    - Paradigm Health System
    - Ta kontakt med:
      
      Patrick Glynn, MD
      
      Telefonnummer: 985-882-4500
      
      E-post: trickpatglynn@yahoo.com
- Maryland
  - Columbia, Maryland, Forente stater, 21044
    - Rekruttering
    - Erlanger Health System
    - Ta kontakt med:
      
      Joshua Alpers, MD
      
      Telefonnummer: 423-778-9001
      
      E-post: joshua.alpers@erlanger.org
- Michigan
  - Ann Arbor, Michigan, Forente stater, 48109
    - Rekruttering
    - University of Michigan Hospital
    - Ta kontakt med:
      
      Amro Stino, MD
      
      Telefonnummer: 734-936-8586
      
      E-post: amstino@umich.edu
- Ohio
  - Cincinnati, Ohio, Forente stater, 45267-2827
    - Rekruttering
    - University of Cincinnati Health
    - Ta kontakt med:
      
      Hani Kushlaf, MD
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
- Pennsylvania
  - Philadelphia, Pennsylvania, Forente stater, 19107
    - Rekruttering
    - Jefferson Health Honickman Center
    - Ta kontakt med:
      
      Goran Rakocevic, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: clinicaltrials@argenx.com
  - Philadelphia, Pennsylvania, Forente stater, 19104-5127
    - Rekruttering
    - Perelman Center for Advanced Medicine
    - Ta kontakt med:
      
      Michael Baer, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: clinicaltrials@argenx.com
- Tennessee
  - Knoxville, Tennessee, Forente stater, 37909
    - Rekruttering
    - University Neurology
    - Ta kontakt med:
      
      Christopher Scheiner, MD
      
      Telefonnummer: 8660000000
      
      E-post: cscheiner@utmck.edu
- Texas
  - Houston, Texas, Forente stater, 77094
    - Rekruttering
    - NeuroCarePlus
    - Ta kontakt med:
      
      Nicolas Nammour, MD
      
      Telefonnummer: 281-579-6800
      
      E-post: nicolas.nammour@sclamanagement.com
  - Irving, Texas, Forente stater, 75063
    - Rekruttering
    - National Neuromuscular Research Institute
    - Ta kontakt med:
      
      Yessar Hussain, MD
      
      Telefonnummer: 512-920-0140
      
      E-post: yessar@austinneuromuscle.com
Frankrike
- - Bordeaux, Frankrike, 33076
    - Rekruttering
    - CHU de Bordeaux - Hôpital Pellegrin
    - Ta kontakt med:
      
      Gwendal Le Masson, MD
      
      Telefonnummer: +33557821392
      
      E-post: gwendal.le-masson@chu-bordeaux.fr
  - Le Kremlin-Bicêtre, Frankrike, 94270
    - Rekruttering
    - AP-HP - Hôpital Bicêtre
    - Ta kontakt med:
      
      Andoni Echaniz-Laguna, MD
      
      Telefonnummer: +33145213159
      
      E-post: andoni.echaniz-laguna@aphp.fr
  - Nice, Frankrike, 6001
    - Rekruttering
    - CHU de Nice-Hôpital Pasteur
    - Ta kontakt med:
      
      Sabrina Sacconi, MD
      
      Telefonnummer: +33492035757
      
      E-post: sacconi.s@chu-nice.fr
  - Strasbourg, Frankrike, 67200
    - Rekruttering
    - CHU de Strasbourg - Hôpital de Hautepierre
    - Ta kontakt med:
      
      Jérôme De Seze, MD
      
      Telefonnummer: +33388116229
      
      E-post: jerome.deseze@chru-strasbourg.fr
  - Toulouse, Frankrike, 31059
    - Rekruttering
    - CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
    - Ta kontakt med:
      
      Pascal Cintas, MD
      
      Telefonnummer: +33561779440
      
      E-post: cintas.p@chu-toulouse.fr
- Bouches-du-Rhone
  - Marseille, Bouches-du-Rhone, Frankrike, 13005
    - Rekruttering
    - AP-HM- Hôpital de La Timone
    - Ta kontakt med:
      
      Shahram Attarian
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
- Paris
  - Paris, Paris, Frankrike, 75013
    - Rekruttering
    - AP-HP - Hôpital de la Pitié Salpétrière
    - Ta kontakt med:
      
      Charline Benoit, MD
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
Hellas
- - Athens, Hellas, 15562
    - Rekruttering
    - University General Hospital of Alexandroupolis
    - Ta kontakt med:
      
      Aikaterini Terzoudi, MD
      
      Telefonnummer: +306977981860
      
      E-post: katerzoudi@hotmail.com
  - Chaïdári, Hellas, 124 62
    - Rekruttering
    - University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
    - Ta kontakt med:
      
      Georgios Tsivgoulis, MD
      
      Telefonnummer: +306937178635
      
      E-post: tsivgoulisgiorg@yahoo.gr
Israel
- - Ashkelon, Israel, 78278
    - Rekruttering
    - The Barzilai University Medical Center
    - Ta kontakt med:
      
      Natalya Tihmanovich, MD
      
      Telefonnummer: +972538000000
      
      E-post: natalyat@bmc.gov.il
  - Jerusalem, Israel, 9112001
    - Rekruttering
    - Hadassah Medical Center- Ein Kerem
    - Ta kontakt med:
      
      Marc Gotkine, MD
      
      Telefonnummer: +97226777741
      
      E-post: marc@gotkine.com
  - Tel HaShomer, Israel, 52621
    - Rekruttering
    - The Chaim Sheba Medical Center
    - Ta kontakt med:
      
      Amir Dori, MD
      
      Telefonnummer: +972526000000
      
      E-post: amir.dori@sheba.health.gov.il
Italia
- - Bologna, Italia, 40139
    - Rekruttering
    - AUSL di Bologna - Ospedale Bellaria
    - Ta kontakt med:
      
      Vincenzo Donadio, MD
      
      Telefonnummer: +390514966113
      
      E-post: vincenzo.donadio@unibo.it
  - Pavia, Italia, 27100
    - Rekruttering
    - Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
    - Ta kontakt med:
      
      Elisa Vegezzi, MD
      
      Telefonnummer: +390382000000
      
      E-post: elisa.vegezzi@mondino.it
  - Roma, Italia, 133
    - Rekruttering
    - Fondazione PTV Policlinico Tor Vergata
    - Ta kontakt med:
      
      Girolama Alessandra Marfia, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: clinicaltrials@argenx.com
  - Roma, Italia, 161
    - Rekruttering
    - Azienda Ospedaliero-Universitaria Policlinico Umberto I
    - Ta kontakt med:
      
      Antonio Suppa, MD
      
      Telefonnummer: +390649978750
      
      E-post: antonio.suppa@uniroma1.it
  - Roma, Italia, 00189
    - Rekruttering
    - Azienda Ospedaliero-Universitaria Sant'Andrea
    - Ta kontakt med:
      
      Stefania Morino, MD
      
      Telefonnummer: +390634000000
      
      E-post: stefania.morino@ospedalesantandrea.it
  - Rozzano, Italia, 20089
    - Rekruttering
    - IRCCS Istituto Clinico Humanitas
    - Ta kontakt med:
      
      Pietro Emiliano Doneddu, MD
- Emilia-Romagna
  - Bologna, Emilia-Romagna, Italia, 40139
    - Rekruttering
    - AUSL di Bologna - Ospedale Bellaria
    - Ta kontakt med:
      
      Vincenzo Donadio
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
Japan
- - Aomori, Japan, 030-8553
    - Rekruttering
    - Aomori Prefectural Central Hospital
    - Ta kontakt med:
      
      Tatsuya Ueno, MD
      
      Telefonnummer: +81177268111
      
      E-post: tatsuya_ueno@med.pref.aomori.jp
  - Bunkyō City, Japan, 113-8431
    - Rekruttering
    - Juntendo University Hospital
    - Ta kontakt med:
      
      Yuji Tomizawa, MD
      
      Telefonnummer: +81338213111
      
      E-post: zawa@juntendo.ac.jp
  - Chūōku, Japan, 260-8677
    - Rekruttering
    - Chiba University Hospital
    - Ta kontakt med:
      
      Kazumoto Shibuya, MD
      
      Telefonnummer: +81432227171
      
      E-post: kazumoto@net.email.ne.jp
  - Hiroshima, Japan, 430-8558
    - Rekruttering
    - Seirei Hamamatsu Hospital
    - Ta kontakt med:
      
      Keishiro Sato, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: clinicaltrials@argenx.com
  - Izunokuni, Japan, 410-2295
    - Rekruttering
    - Juntendo Shizuoka University Hospital
    - Ta kontakt med:
      
      Kazuyuki Noda, MD
      
      Telefonnummer: +81559483111
      
      E-post: k-noda@juntendo.ac.jp
  - Osaka, Japan, 545-8586
    - Rekruttering
    - Osaka Metropolitan University Hospital
    - Ta kontakt med:
      
      Yoshiaki Itoh, MD
      
      Telefonnummer: +81666453889
      
      E-post: a21337r@omu.ac.jp
  - Saga, Japan, 849-8501
    - Rekruttering
    - Saga University Hospital
    - Ta kontakt med:
      
      Haruki Koike, MD
      
      Telefonnummer: +81952316511
      
      E-post: haruki.koike@gmail.com
  - Shimotsuke, Japan, 329-0498
    - Rekruttering
    - Jichi Medical University Hospital
    - Ta kontakt med:
      
      Shigeru Fujimoto, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: clinicaltrials@argenx.com
  - Tsuchiura, Japan, 300-0028
    - Rekruttering
    - General Hospital Tsuchiura Kyodo Hospital
    - Ta kontakt med:
      
      Akira Machida, MD
      
      Telefonnummer: 8888888888
      
      E-post: akinuro@tmd.ac.jp
  - Ube, Japan, 755-0067
    - Rekruttering
    - Yamaguchi University Hospital
    - Ta kontakt med:
      
      Masayuki Nakamori, MD
      
      Telefonnummer: +81836222111
      
      E-post: mnakamori@neurol.med.osaka-u.ac.jp
Nederland
- - Utrecht, Nederland, 3584 CX
    - Rekruttering
    - Universitair Medisch Centrum Utrecht
    - Ta kontakt med:
      
      Ludo van der Pol, MD
      
      Telefonnummer: +31887551546
      
      E-post: w.l.vanderpol@umcutrecht.nl
Norge
- - Oslo, Norge, 450
    - Rekruttering
    - Oslo Universitetssykehus HF, Ullevål
    - Ta kontakt med:
      
      Angelina Maniaol, MD
      
      Telefonnummer: +4791502770
      
      E-post: angman@ous-hf.no
Polen
- - Bydgoszcz, Polen, 85-065
    - Rekruttering
    - MICS Centrum Medyczne Bydgoszcz
    - Ta kontakt med:
      
      Lukasz Rzepinski, MD
      
      Telefonnummer: +48523401414
      
      E-post: luk.rzepinski@gmail.com
  - Bydgoszcz, Polen, 85-796
    - Rekruttering
    - Neurocentrum Bydgoszcz
    - Ta kontakt med:
      
      Robert Bonek, MD
      
      Telefonnummer: +48601633810
      
      E-post: r.bonek@ncbydgoszcz.pl
  - Katowice, Polen, 40-689
    - Rekruttering
    - Centrum Medyczne Neurologia Slaska
    - Ta kontakt med:
      
      Marek Smilowski, MD
      
      Telefonnummer: +48500282494
      
      E-post: marek.smilowski@neurologiaslaska.pl
  - Krakow, Polen, 30-721
    - Rekruttering
    - Centrum Medyczne Linden
    - Ta kontakt med:
      
      Karolina Porebska, MD
      
      Telefonnummer: +48530868350
      
      E-post: kspisak@poczta.fm
  - Krakow, Polen, 30-688
    - Rekruttering
    - SP ZOZ Szpital Uniwersytecki w Krakowie
    - Ta kontakt med:
      
      Agnieszka Slowik, MD
      
      Telefonnummer: +48124002551
      
      E-post: neurologiabk@su.krakow.pl
  - Lublin, Polen, 20-064
    - Rekruttering
    - Galen Clinic - Lublin
    - Ta kontakt med:
      
      Urszula Chyrchel-Paszkiewicz, MD
      
      Telefonnummer: +48817244720
      
      E-post: pgluchyrchel@gmail.com
  - Poznan, Polen, 61-731
    - Rekruttering
    - Clinical Research Center Sp. z o.o. Medic-R sp.k.
    - Ta kontakt med:
      
      Artur Druzdz, MD
      
      Telefonnummer: +48502121222
      
      E-post: artur.druzdz@cr-center.pl
  - Rzeszów, Polen, 35-210
    - Rekruttering
    - Centrum Medyczne Medyk
    - Ta kontakt med:
      
      Halina Bartosik-Psujek, MD
      
      Telefonnummer: +48517296531
      
      E-post: bartosikpsujek@op.pl
  - Rzeszów, Polen, 35-210
    - Rekruttering
    - Centrum Medyczne Medyk-al. Tadeusza Rejtana 53
    - Ta kontakt med:
      
      Halina Bartosik-Psujek, MD
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
  - Szczecin, Polen, 71-252
    - Rekruttering
    - Uniwersytecki Szpital Kliniczny Nr 1
    - Ta kontakt med:
      
      Marta Masztalewicz, MD
      
      Telefonnummer: +48914253264
      
      E-post: marta.masztalewicz@pum.edu.pl
  - Szczecin, Polen, 71-252
    - Rekruttering
    - Uniwersytecki Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie
    - Ta kontakt med:
      
      Marta Masztalewicz, MD
      
      Telefonnummer: +48914253264
      
      E-post: marta.masztalewicz@pum.edu.pl
  - Warsaw, Polen, 02-097
    - Rekruttering
    - Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
    - Ta kontakt med:
      
      Anna Kostera-Pruszczyk, MD
      
      Telefonnummer: +48225992858
      
      E-post: anna.kostera-pruszczyk@wum.edu.pl
Portugal
- - Porto, Portugal, 4050-342
    - Rekruttering
    - ULS de Santo António, EPE - Hospital de Santo António
    - Ta kontakt med:
      
      Ernestina Santos, MD
      
      Telefonnummer: +351222077500
      
      E-post: ernestina.santos@gmail.com
Romania
- - Bucharest, Romania, 41914
    - Rekruttering
    - Institutul National de Neurologie si Boli Neurovasculare Bucuresti
    - Ta kontakt med:
      
      Florian Antonescu, MD
      
      Telefonnummer: +40722465793
      
      E-post: dr.antonescu@yahoo.com
  - Constanța, Romania, 900348
    - Rekruttering
    - Brainaxy Clinic SRL
    - Ta kontakt med:
      
      Any Axelerad, MD
      
      Telefonnummer: +40726393236
      
      E-post: docuaxi@yahoo.com
  - Târgu Mureş, Romania, 540136
    - Rekruttering
    - Targu-Mures Emergency Clinical County Hospital
    - Ta kontakt med:
      
      Anca Motataianu, MD
      
      Telefonnummer: +40726673472
      
      E-post: motataianuanca@gmail.com
- Bucharest
  - Bucharest, Bucharest, Romania, 41914
    - Rekruttering
    - Institutul National de Neurologie si Boli Neuroavasculare Bucuresti
    - Ta kontakt med:
      
      Florian Antonescu
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
Serbia
- - Belgrade, Serbia, 11000
    - Rekruttering
    - University Clinical Center of Serbia - Dr Subotica 6
    - Ta kontakt med:
      
      Ivana Basta, MD
      
      Telefonnummer: +381668000000
      
      E-post: ivanabasta@yahoo.com
  - Niš, Serbia, 18 000
    - Rekruttering
    - University Clinical Center Nis
    - Ta kontakt med:
      
      Gordana Djordjevic, MD
      
      Telefonnummer: +381184000000
      
      E-post: gordanadjor@gmail.com
Singapore
- - Singapore, Singapore, 308433
    - Rekruttering
    - National Neuroscience Institute
    - Ta kontakt med:
      
      Peng Soon Ng, MD
      
      Telefonnummer: 6563306363
      
      E-post: ng.peng.soon@singhealth.com.sg
Slovakia
- - Martin, Slovakia, 036 59
    - Rekruttering
    - Univerzitna nemocnica MARTIN
    - Ta kontakt med:
      
      Monika Turcanova Koprusakova, MD
      
      Telefonnummer: +421434203660
      
      E-post: koprusakova@gmail.com
Slovenia
- - Ljubljana, Slovenia, 1000
    - Rekruttering
    - University Medical Centre Ljubljana
    - Ta kontakt med:
      
      Blaz Koritnik, MD
      
      Telefonnummer: +38615221501
      
      E-post: blaz.koritnik@kclj.si
  - Maribor, Slovenia, 2000
    - Rekruttering
    - University Clinical Centre Maribor
    - Ta kontakt med:
      
      Timotej Petrijan, MD
      
      Telefonnummer: +38623212364
      
      E-post: timotej.petrijan@ukc-mb.si
Spania
- - Barcelona, Spania, 08041
    - Rekruttering
    - Hospital de La Santa Creu i Sant Pau
    - Ta kontakt med:
      
      Luis Querol, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: clinicaltrials@argenx.com
  - Madrid, Spania, 28007
    - Rekruttering
    - Hospital General Universitario Gregorio Marañon
    - Ta kontakt med:
      
      Irene Catalina Alvarez, MD
      
      Telefonnummer: +34669242893
      
      E-post: uelanm.hgugm@salud.madrid.org
  - Sant Andreu de la Barca, Spania, 08740
    - Rekruttering
    - Hospital Universitario Vall d'Hebron
    - Ta kontakt med:
      
      Raúl Juntas Morales, MD
      
      Telefonnummer: +34934896000
      
      E-post: raul.juntas@vallhebron.cat
  - Seville, Spania, 41009
    - Rekruttering
    - Hospital Universitario Virgen Macarena
    - Ta kontakt med:
      
      Eva Maria Martínez Fernández, MD
      
      Telefonnummer: +34600162109
      
      E-post: emmartinezf@yahoo.es
Storbritannia
- - Leeds, Storbritannia, LS1 3EX
    - Rekruttering
    - Leeds General Infirmary
    - Ta kontakt med:
      
      Priya Shanmugarajah, MD
      
      E-post: priya.shanmugarajah@nhs.net
  - London, Storbritannia, WC1N 3BG
    - Rekruttering
    - The National Hospital for Neurology and Neurosurgery - PPDS
    - Ta kontakt med:
      
      Junie (Shiwen) Koay, MD
      
      E-post: shiwen.koay@nhs.net
- Lancashire
  - Salford, Lancashire, Storbritannia, M6 8HD
    - Rekruttering
    - Salford Royal Hospital - PPDS
    - Ta kontakt med:
      
      Ryan (Yann Shern) Keh, MD
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
Sveits
- - Geneva, Sveits, 1205
    - Rekruttering
    - Hôpitaux Universitaires de Genève (HUG)
    - Ta kontakt med:
      
      Agustina Lascano, MD
      
      Telefonnummer: +41223725283
      
      E-post: agustina.lascano@hcuge.ch
Sverige
- - Gothenburg, Sverige, 41346
    - Rekruttering
    - Sahlgrenska University Hospital
    - Ta kontakt med:
      
      Lenka Novakova Nyren, MD
      
      Telefonnummer: +46313424107
      
      E-post: lenka.novakova@vgregion.se
Sør -Korea
- - Busan, Sør -Korea, 48108
    - Rekruttering
    - Inje University Haeundae Paik Hospital
    - Ta kontakt med:
      
      Kyong Jin Shin, MD
      
      Telefonnummer: +82517972080
      
      E-post: neurof@naver.com
  - Seoul, Sør -Korea, 03080
    - Rekruttering
    - Seoul National University Hospital
    - Ta kontakt med:
      
      Sung Min Kim, MD
      
      Telefonnummer: +82220727312
      
      E-post: sueh916@gmail.com
  - Seoul, Sør -Korea, 05030
    - Rekruttering
    - Konkuk University Medical Center
    - Ta kontakt med:
      
      Jee Young Oh, MD
      
      Telefonnummer: +82220307564
      
      E-post: 20050324@kuh.ac.kr
  - Seoul, Sør -Korea, 03722
    - Rekruttering
    - Severance Hospital Yonsei University Health System
    - Ta kontakt med:
      
      Ha Young Shin, MD
      
      Telefonnummer: +82222281600
      
      E-post: hayshin@yuhs.ac
Tsjekkia
- - Brno, Tsjekkia
    - Rekruttering
    - Fakultni nemocnice Brno
    - Ta kontakt med:
      
      Magda Horakova, MD
      
      Telefonnummer: +420734427851
      
      E-post: horakova.magda@fnbrno.cz
Tyrkia (Türkiye)
- - Istanbul, Tyrkia (Türkiye), 34083
    - Rekruttering
    - Istanbul Tip Fakultesi Hastanesi (Istanbul Universitesi)
    - Ta kontakt med:
      
      Arman Cakar, MD
      
      Telefonnummer: 857-350-4834
      
      E-post: ClinicalTrials@argenx.com
  - Samsun, Tyrkia (Türkiye), 55200
    - Rekruttering
    - Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
    - Ta kontakt med:
      
      Murat Terzi, MD
      
      Telefonnummer: +905323000000
      
      E-post: mterzi@omu.edu.tr
Tyskland
- - Berlin, Tyskland, 13353
    - Rekruttering
    - Charité - Universitätsmedizin Berlin
    - Ta kontakt med:
      
      Frauke Stascheit, MD
      
      Telefonnummer: +4930450639724
      
      E-post: frauke.stascheit@charite.de
  - Kiel, Tyskland, 24105
    - Rekruttering
    - Universitätsklinikum Schleswig-Holstein - Campus Kiel
    - Ta kontakt med:
      
      Frank Leypoldt, MD
      
      Telefonnummer: +4943150016209
      
      E-post: Frank.leypoldt@uksh.de
Ungarn
- - Budapest, Ungarn, 1085
    - Rekruttering
    - Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete
    - Ta kontakt med:
      
      Maria Judit Molnar, MD
      
      E-post: molnarmj@gmail.com
Østerrike
- - Linz, Østerrike
    - Rekruttering
    - Kepler Universitätsklinikum Linz - Med Campus III
    - Ta kontakt med:
      
      Christian Eggers, MD
      
      Telefonnummer: +1 857-350-4834
      
      E-post: clinicaltrials@argenx.com
  - Vienna, Østerrike, 1090
    - Rekruttering
    - Universitätsklinikum AKH Wien
    - Ta kontakt med:
      
      Jakob Rath, MD
      
      Telefonnummer: +4314040031170
      
      E-post: jakob.rath@meduniwien.ac.at

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm Deltakergruppe / Arm En gruppe eller undergruppe av deltakere i en klinisk studie som mottar en spesifikk intervensjon/behandling, eller ingen intervensjon, i henhold til studiens protokoll.	Intervensjon / Behandling Intervensjon / Behandling En prosess eller handling som er fokus for en klinisk studie. Intervensjoner inkluderer legemidler, medisinsk utstyr, prosedyrer, vaksiner og andre produkter som enten er undersøkende eller allerede er tilgjengelige. Intervensjoner kan også inkludere ikke-invasive tilnærminger, som utdanning eller modifisering av kosthold og trening.
Eksperimentell: Part A - empasiprubart + IVIg-placebo During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.	Annen: IVIg-placebo A placebo resembling the IVIg treatment Biologisk: empasiprubart Intravenous infusion of empasiprubart
Aktiv komparator: Part A - IVIg + empasiprubart-placebo During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm.	Biologisk: IVIg Intravenous infusion of IVIg Annen: empasiprubart-placebo A placebo resembling the empasiprubart treatment
Eksperimentell: Part B - empasiprubart After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg). Participants from the empasiprubart + IVIg- placebo arm in Part A will receive empasiprubart placebo once to maintain the blind of Part A.	Biologisk: empasiprubart Intravenous infusion of empasiprubart Annen: empasiprubart-placebo A placebo resembling the empasiprubart treatment

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Reduction of ≥1 point compared with baseline in aINCAT score at week 24 Tidsramme: up to 24 weeks	The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).	up to 24 weeks

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Prosentandel av planlagte timer tapt totalt (fravær+ presentisme) Tidsramme: opptil 24 uker		opptil 24 uker
Forekomst av antidrug Antistoffer mot Empasiprubart i serum Tidsramme: Opptil 24 uker (del A) + 96 uker (del B)		Opptil 24 uker (del A) + 96 uker (del B)
Forekomst av nøytraliserende antistoffer mot empasiprubart i serum Tidsramme: Opptil 24 uker (del A) + 96 uker (del B)		Opptil 24 uker (del A) + 96 uker (del B)
Forekomst av (alvorlige) bivirkninger Tidsramme: Opptil 24 uker (del A) + 96 uker (del B)		Opptil 24 uker (del A) + 96 uker (del B)
Prosentvis endring fra baseline i gratis C2 og total C2 over tid Tidsramme: Opptil 24 uker (del A) + 96 uker (del B)		Opptil 24 uker (del A) + 96 uker (del B)
Serumkonsentrasjoner av empasiprubart over tid Tidsramme: Opptil 24 uker (del A) + 96 uker (del B)		Opptil 24 uker (del A) + 96 uker (del B)
Change from baseline in I-RODS centile points score at week 24 Tidsramme: up to 24 weeks	Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome).	up to 24 weeks
Change from baseline in MRC-SS at week 24 Tidsramme: up to 24 weeks	The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome).	up to 24 weeks
Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24 Tidsramme: up to 24 weeks	The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days.	up to 24 weeks
Time to reduction of ≥1 point from baseline in aINCAT score Tidsramme: up to 24 weeks	The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).	up to 24 weeks
Change from baseline in TUG at week 24 Tidsramme: up to 24 weeks	The Timed Up and Go Test (TUG) is a simple test to assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured.	up to 24 weeks
Time to increase of ≥1 point compared with baseline in aINCAT score Tidsramme: Up to 24 weeks	The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).	Up to 24 weeks
Change from baseline in grip strength (3-day moving average) of both hands over time Tidsramme: up to 24 weeks + 96 weeks (Part B)	The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. The 3-day moving average will be generated based on the average of the obtained averages for each hand on the target day and the preceding 2 days.	up to 24 weeks + 96 weeks (Part B)
Change from baseline in grip strength (daily average) for both hands Tidsramme: up to 24 weeks + 96 weeks (Part B)	The grip strength will be measured daily by using a Martin-Vigorimeter. The 3 daily measurements of grip strength from the left hand and the 3 daily measurements of grip strength from the right hand will be recorded, and the daily average for the left hand and right hand will be calculated, respectively. A daily average will be generated based on the average of the obtained averages for each hand.	up to 24 weeks + 96 weeks (Part B)
Change from baseline in MRC-SS over time Tidsramme: up to 96 weeks (Part B)	The Medical Research Council Sum Score evaluates motor strength. Evaluated on 6 muscle groups on each side, the score varies from 0 to 60 (lower score, worse outcome).	up to 96 weeks (Part B)
Change from baseline in aINCAT over time Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)	The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).	up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in EQ-5D-5L over time Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)	EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome).	up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in RT-FSS over time Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)	Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a patient-reported outcome measure to distinguish fatigue from clinical depression.	up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in SF-12 over time Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)	12-Item Short Form Health Survey (SF-12) is a general patient-reported outcome measure.	up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in BPI-SF over time Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)	The Brief Pain Inventory-Short Form (BPI-SF) is a patient-reported outcome measure to assess pain severity and pain interference.	up to 24 weeks (Part A) + 96 weeks (Part B)
PGI-S values over time Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)	The Patient Global Impression of Severity (PGI-S) is a patient-reported outcome measure that reflects the patient's belief about the severity of the illness.	up to 24 weeks (Part A) + 96 weeks (Part B)
PGI-C values over time Tidsramme: up to 24 weeks (Part A) + 96 weeks (Part B)	The Patient Global Impression of Change (PGI-C) is a patient- reported outcome measure that reflects the patient's belief about the efficacy of treatment.	up to 24 weeks (Part A) + 96 weeks (Part B)
Values for work-related and household chore activities of the HRPQ Tidsramme: up to 24 weeks	The Health-Related Productivity Questionnaire (HRPQ) assesses health-related and work-related productivity, with questions related to 'hours lost because of absenteeism'.	up to 24 weeks
Change from baseline in I-RODS centile points score over time Tidsramme: Up to 96 weeks (Part B)	Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. The score ranges from 0 to 100 (higher score, worse outcome).	Up to 96 weeks (Part B)
Change from baseline in TUG over time Tidsramme: Up to 96 weeks (Part B)	The Timed Up and Go Test (TUG) is a simple test to assess a person's mobility in which the time expended to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is measured.	Up to 96 weeks (Part B)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

argenx

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

<p>Study website</p>

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. august 2025

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. september 2030

Datoer for studieregistrering

Først innsendt

26. mars 2025

Først innsendt som oppfylte QC-kriteriene

2. april 2025

Først lagt ut (Faktiske)

9. april 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

ARGX-117-2401
2024-520097-36-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

En studie for å vurdere effekt og sikkerhet for Empasiprubart versus IVIG hos voksne med CIDP (emvigorate)

En fase 3, randomisert, dobbeltblindet, dobbelt-dummy studie som evaluerer effektiviteten og sikkerheten til intravenøs empasiprubart versus intravenøs immunoglobulin hos voksne med kronisk inflammatorisk demyeliniserende polyneuropati

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Studietype

Registrering (Antatt)

Fase

Kontakter og plasseringer

Studiekontakt

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Publikasjoner og nyttige lenker

Hjelpsomme linker

Studierekorddatoer

Studer hoveddatoer

Studiestart (Faktiske)

Primær fullføring (Antatt)

Studiet fullført (Antatt)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Faktiske)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt