Chronic Inflammatory Demyelinating PolyneuropathyPhase 3emvigorateNCT06920004
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
A Phase 3 study testing empasiprubart and IVIg in people with Chronic Inflammatory Demyelinating Polyneuropathy and CIDP, run by argenx at 102 sites in 31 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- empasiprubart and IVIg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 102 sitesin 31 countries
- Study dates
- 22 Aug 2025to Sep 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
102 sites in 31 countries. Contact the study team or a site near you to ask about taking part.
102 sites in 31 countries
United States16 sites, 16 recruiting
- Recruiting
University of Michigan Hospital
Ann Arbor, Michigan, 48109
Amro Stino, MD, 734-936-8586, amstino@umich.edu
- Recruiting
University of Alabama
Birmingham, Alabama, 35233
Eroboghene Ubogu, MD, 857-350-4834, ubogu@uab.edu
- Recruiting
University of Cincinnati Health
Cincinnati, Ohio, 45267-2827
Hani Kushlaf, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
David Stevens, MD, 719-473-3272, dstevens@csneuro.com
- Recruiting
Erlanger Health System
Columbia, Maryland, 21044
Joshua Alpers, MD, 423-778-9001, joshua.alpers@erlanger.org
- Recruiting
Homestead Associates in Research Inc
Homestead, Florida, 33033
Christopher Jimenez, MD, 305-246-0873, cjimenez@associatesinresearch.com
- Recruiting
NeuroCarePlus
Houston, Texas, 77094
Nicolas Nammour, MD, 281-579-6800, nicolas.nammour@sclamanagement.com
- Recruiting
National Neuromuscular Research Institute
Irving, Texas, 75063
Yessar Hussain, MD, 512-920-0140, yessar@austinneuromuscle.com
- Recruiting
Visionary Investigators Network
Miami, Florida, 33133
Andrew Lerman, MD, 786-655-8010, alerman@fcneurology.net
- Recruiting
Baptist Health Medical Group Neurology
Nicholasville, Kentucky, 40356-6066
James Winkley, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104-5127
Michael Baer, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107
Goran Rakocevic, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Samir Macwan, M.D., Inc.
Rancho Mirage, California, 922701
Samir Macwan, MD, 760-531-4068, samirmacwan@gmail.com
- Recruiting
Paradigm Health System
Slidell, Louisiana, 70458
Patrick Glynn, MD, 985-882-4500, trickpatglynn@yahoo.com
- Recruiting
University of South Florida
Tampa, Florida, 33616
Kathleen Murray, MD, 813-974-9713, kmurray11@usf.edu
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Yasir Al-Khalili, MD, 857-350-4834, clinicaltrials@argenx.com
Poland12 sites, 12 recruiting
- Recruiting
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065
Lukasz Rzepinski, MD, +48523401414, luk.rzepinski@gmail.com
- Recruiting
Neurocentrum Bydgoszcz
Bydgoszcz, 85-796
Robert Bonek, MD, +48601633810, r.bonek@ncbydgoszcz.pl
- Recruiting
Centrum Medyczne Neurologia Slaska
Katowice, 40-689
Marek Smilowski, MD, +48500282494, marek.smilowski@neurologiaslaska.pl
- Recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 30-688
Agnieszka Slowik, MD, +48124002551, neurologiabk@su.krakow.pl
- Recruiting
Centrum Medyczne Linden
Krakow, 30-721
Karolina Porebska, MD, +48530868350, kspisak@poczta.fm
- Recruiting
Galen Clinic - Lublin
Lublin, 20-064
Urszula Chyrchel-Paszkiewicz, MD, +48817244720, pgluchyrchel@gmail.com
- Recruiting
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Poznan, 61-731
Artur Druzdz, MD, +48502121222, artur.druzdz@cr-center.pl
- Recruiting
Centrum Medyczne Medyk-al. Tadeusza Rejtana 53
Rzeszów, 35-210
Halina Bartosik-Psujek, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Centrum Medyczne Medyk
Rzeszów, 35-210
Halina Bartosik-Psujek, MD, +48517296531, bartosikpsujek@op.pl
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie
Szczecin, 71-252
Marta Masztalewicz, MD, +48914253264, marta.masztalewicz@pum.edu.pl
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 1
Szczecin, 71-252
Marta Masztalewicz, MD, +48914253264, marta.masztalewicz@pum.edu.pl
- Recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, 02-097
Anna Kostera-Pruszczyk, MD, +48225992858, anna.kostera-pruszczyk@wum.edu.pl
Japan10 sites, 10 recruiting
- Recruiting
Aomori Prefectural Central Hospital
Aomori, 030-8553
Tatsuya Ueno, MD, +81177268111, tatsuya_ueno@med.pref.aomori.jp
- Recruiting
Juntendo University Hospital
Bunkyō City, 113-8431
Yuji Tomizawa, MD, +81338213111, zawa@juntendo.ac.jp
- Recruiting
Chiba University Hospital
Chūōku, 260-8677
Kazumoto Shibuya, MD, +81432227171, kazumoto@net.email.ne.jp
- Recruiting
Seirei Hamamatsu Hospital
Hiroshima, 430-8558
Keishiro Sato, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Juntendo Shizuoka University Hospital
Izunokuni, 410-2295
Kazuyuki Noda, MD, +81559483111, k-noda@juntendo.ac.jp
- Recruiting
Osaka Metropolitan University Hospital
Osaka, 545-8586
Yoshiaki Itoh, MD, +81666453889, a21337r@omu.ac.jp
- Recruiting
Saga University Hospital
Saga, 849-8501
Haruki Koike, MD, +81952316511, haruki.koike@gmail.com
- Recruiting
Jichi Medical University Hospital
Shimotsuke, 329-0498
Shigeru Fujimoto, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
General Hospital Tsuchiura Kyodo Hospital
Tsuchiura, 300-0028
Akira Machida, MD, 8888888888, akinuro@tmd.ac.jp
- Recruiting
Yamaguchi University Hospital
Ube, 755-0067
Masayuki Nakamori, MD, +81836222111, mnakamori@neurol.med.osaka-u.ac.jp
France7 sites, 7 recruiting
- Recruiting
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33076
Gwendal Le Masson, MD, +33557821392, gwendal.le-masson@chu-bordeaux.fr
- Recruiting
AP-HP - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Andoni Echaniz-Laguna, MD, +33145213159, andoni.echaniz-laguna@aphp.fr
- Recruiting
AP-HM- Hôpital de La Timone
Marseille, Bouches-du-Rhone, 13005
Shahram Attarian, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
CHU de Nice-Hôpital Pasteur
Nice, 6001
Sabrina Sacconi, MD, +33492035757, sacconi.s@chu-nice.fr
- Recruiting
AP-HP - Hôpital de la Pitié Salpétrière
Paris, Paris, 75013
Charline Benoit, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67200
Jérôme De Seze, MD, +33388116229, jerome.deseze@chru-strasbourg.fr
- Recruiting
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
Toulouse, 31059
Pascal Cintas, MD, +33561779440, cintas.p@chu-toulouse.fr
Italy7 sites, 7 recruiting
- Recruiting
AUSL di Bologna - Ospedale Bellaria
Bologna, Emilia-Romagna, 40139
Vincenzo Donadio, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
AUSL di Bologna - Ospedale Bellaria
Bologna, 40139
Vincenzo Donadio, MD, +390514966113, vincenzo.donadio@unibo.it
- Recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS
Pavia, 27100
Elisa Vegezzi, MD, +390382000000, elisa.vegezzi@mondino.it
- Recruiting
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, 00189
Stefania Morino, MD, +390634000000, stefania.morino@ospedalesantandrea.it
- Recruiting
Fondazione PTV Policlinico Tor Vergata
Roma, 133
Girolama Alessandra Marfia, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Roma, 161
Antonio Suppa, MD, +390649978750, antonio.suppa@uniroma1.it
- Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
Pietro Emiliano Doneddu, MD
Romania4 sites, 4 recruiting
- Recruiting
Institutul National de Neurologie si Boli Neuroavasculare Bucuresti
Bucharest, Bucharest, 41914
Florian Antonescu, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Institutul National de Neurologie si Boli Neurovasculare Bucuresti
Bucharest, 41914
Florian Antonescu, MD, +40722465793, dr.antonescu@yahoo.com
- Recruiting
Brainaxy Clinic SRL
Constanța, 900348
Any Axelerad, MD, +40726393236, docuaxi@yahoo.com
- Recruiting
Targu-Mures Emergency Clinical County Hospital
Târgu Mureş, 540136
Anca Motataianu, MD, +40726673472, motataianuanca@gmail.com
South Korea4 sites, 4 recruiting
- Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
Kyong Jin Shin, MD, +82517972080, neurof@naver.com
- Recruiting
Seoul National University Hospital
Seoul, 03080
Sung Min Kim, MD, +82220727312, sueh916@gmail.com
- Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
Ha Young Shin, MD, +82222281600, hayshin@yuhs.ac
- Recruiting
Konkuk University Medical Center
Seoul, 05030
Jee Young Oh, MD, +82220307564, 20050324@kuh.ac.kr
Spain4 sites, 4 recruiting
- Recruiting
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041
Luis Querol, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Irene Catalina Alvarez, MD, +34669242893, uelanm.hgugm@salud.madrid.org
- Recruiting
Hospital Universitario Vall d'Hebron
Sant Andreu de la Barca, 08740
Raúl Juntas Morales, MD, +34934896000, raul.juntas@vallhebron.cat
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Eva Maria Martínez Fernández, MD, +34600162109, emmartinezf@yahoo.es
Colombia3 sites, 3 recruiting
- Recruiting
Hospital Universitario San Ignacio
Bogotá, 110231
Alba Lucia Marentes Cubillos, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Hospital Alma Máter de Antioquia
Medellín, 50012
Juan Gomez, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico
Medellín, 50012
Lina Maria Agudelo Ramos, MD, 857-350-4834, clinicaltrials@argenx.com
Israel3 sites, 3 recruiting
- Recruiting
The Barzilai University Medical Center
Ashkelon, 78278
Natalya Tihmanovich, MD, +972538000000, natalyat@bmc.gov.il
- Recruiting
Hadassah Medical Center- Ein Kerem
Jerusalem, 9112001
Marc Gotkine, MD, +97226777741, marc@gotkine.com
- Recruiting
The Chaim Sheba Medical Center
Tel Litwinsky, 52621
Amir Dori, MD, +972526000000, amir.dori@sheba.health.gov.il
United Kingdom3 sites, 3 recruiting
- Recruiting
Leeds General Infirmary
Leeds, LS1 3EX
Priya Shanmugarajah, MD, priya.shanmugarajah@nhs.net
- Recruiting
The National Hospital for Neurology and Neurosurgery - PPDS
London, WC1N 3BG
Junie (Shiwen) Koay, MD, shiwen.koay@nhs.net
- Recruiting
Salford Royal Hospital - PPDS
Salford, Lancashire, M6 8HD
Ryan (Yann Shern) Keh, MD, +1 857-350-4834, clinicaltrials@argenx.com
Argentina2 sites, 2 recruiting
- Recruiting
Instituto Privado Kremer
Córdoba, X5004AOA
Carlos Deabato, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
INECO Neurociencias Oroño
Rosario, S2000DTP
Darío Tavolini, MD, +5493420000000, dtavolini@inecoorono.org
Austria2 sites, 2 recruiting
- Recruiting
Kepler Universitätsklinikum Linz - Med Campus III
Linz
Christian Eggers, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum AKH Wien
Vienna, 1090
Jakob Rath, MD, +4314040031170, jakob.rath@meduniwien.ac.at
Brazil2 sites, 2 recruiting
- Recruiting
PSEG Centro de Pesquisa Clinica - Rua Borges Lagoa 1060
São Paulo, São Paulo, 04038-002
Paulo Sgobbi de Souza, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
PSEG Centro de Pesquisa Clinica
São Paulo, 04038-002
Paulo Sgobbi de Souza, MD, 857-350-4834, clinicaltrials@argenx.com
Canada2 sites, 2 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Theodore Mobach, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Black Tusk Research Group
Vancouver, British Columbia, V6Z2C7
Katherine Beadon, MD, +1 857-350-4834, clinicaltrials@argenx.com
Estonia2 sites, 2 recruiting
- Recruiting
Astra Kliinik
Tallinn, 11315
Katrin Gross-Paju, MD, +37253323052, katrin.gross-paju@astrakliinik.ee
- Recruiting
Tartu University Hospital
Tartu, 50406
Liis Väli, MD, +3727318543, Liis.Vali@kliinikum.ee
Germany2 sites, 2 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 13353
Frauke Stascheit, MD, +4930450639724, frauke.stascheit@charite.de
- Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, 24105
Frank Leypoldt, MD, +4943150016209, Frank.leypoldt@uksh.de
Greece2 sites, 2 recruiting
- Recruiting
University General Hospital of Alexandroupolis
Athens, 15562
Aikaterini Terzoudi, MD, +306977981860, katerzoudi@hotmail.com
- Recruiting
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári, 124 62
Georgios Tsivgoulis, MD, +306937178635, tsivgoulisgiorg@yahoo.gr
Serbia2 sites, 2 recruiting
- Recruiting
University Clinical Center of Serbia - Dr Subotica 6
Belgrade, 11000
Ivana Basta, MD, +381668000000, ivanabasta@yahoo.com
- Recruiting
University Clinical Center Nis
Niš, 18 000
Gordana Djordjevic, MD, +381184000000, gordanadjor@gmail.com
Slovenia2 sites, 2 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Blaz Koritnik, MD, +38615221501, blaz.koritnik@kclj.si
- Recruiting
University Clinical Centre Maribor
Maribor, 2000
Timotej Petrijan, MD, +38623212364, timotej.petrijan@ukc-mb.si
Australia1 site, 1 recruiting
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2179
Cecilia Cappelen-Smith, MD, +1 857-350-4834, clinicaltrials@argenx.com
Czechia1 site, 1 recruiting
- Recruiting
Fakultni nemocnice Brno
Brno
Magda Horakova, MD, +420734427851, horakova.magda@fnbrno.cz
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete
Budapest, 1085
Maria Judit Molnar, MD, molnarmj@gmail.com
Netherlands1 site, 1 recruiting
- Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Ludo van der Pol, MD, +31887551546, w.l.vanderpol@umcutrecht.nl
Norway1 site, 1 recruiting
- Recruiting
Oslo Universitetssykehus HF, Ullevål
Oslo, 450
Angelina Maniaol, MD, +4791502770, angman@ous-hf.no
Portugal1 site, 1 recruiting
- Recruiting
ULS de Santo António, EPE - Hospital de Santo António
Porto, 4050-342
Ernestina Santos, MD, +351222077500, ernestina.santos@gmail.com
Singapore1 site, 1 recruiting
- Recruiting
National Neuroscience Institute
Singapore, 308433
Peng Soon Ng, MD, 6563306363, ng.peng.soon@singhealth.com.sg
Slovakia1 site, 1 recruiting
- Recruiting
Univerzitna nemocnica MARTIN
Martin, 036 59
Monika Turcanova Koprusakova, MD, +421434203660, koprusakova@gmail.com
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 41346
Lenka Novakova Nyren, MD, +46313424107, lenka.novakova@vgregion.se
Switzerland1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Genève (HUG)
Geneva, 1205
Agustina Lascano, MD, +41223725283, agustina.lascano@hcuge.ch
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi
Samsun, 55200
Murat Terzi, MD, +905323000000, mterzi@omu.edu.tr
About this study
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
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
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
- Being tested
- empasiprubart, IVIg, empasiprubart-placebo, IVIg-placebo
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empasiprubartBiological
Intravenous infusion of empasiprubart
IVIgBiological
Intravenous infusion of IVIg
empasiprubart-placeboOther
A placebo resembling the empasiprubart treatment
IVIg-placeboOther
A placebo resembling the IVIg treatment
| Study group | Role | What they receive |
|---|---|---|
| Part A - empasiprubart + IVIg-placebo | Experimental | During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm. Receives: Biological: empasiprubart; Other: IVIg-placebo |
| Part A - IVIg + empasiprubart-placebo | Active comparator | During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm. Receives: Biological: IVIg; Other: empasiprubart-placebo |
| Part B - empasiprubart | Experimental | 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. Receives: Biological: empasiprubart; Other: empasiprubart-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of ≥1 point compared with baseline in aINCAT score at week 24
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).
Measured: up to 24 weeks
Secondary outcomes (25)
Change from baseline in I-RODS centile points score at week 24
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).
Measured: up to 24 weeks
Change from baseline in MRC-SS at week 24
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).
Measured: up to 24 weeks
Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24
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.
Measured: up to 24 weeks
Time to reduction of ≥1 point from baseline in aINCAT score
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).
Measured: up to 24 weeks
Change from baseline in TUG at week 24
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.
Measured: up to 24 weeks
Time to increase of ≥1 point compared with baseline in aINCAT score
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).
Measured: Up to 24 weeks
Change from baseline in grip strength (3-day moving average) of both hands over time
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.
Measured: up to 24 weeks + 96 weeks (Part B)
Change from baseline in grip strength (daily average) for both hands
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.
Measured: up to 24 weeks + 96 weeks (Part B)
Change from baseline in MRC-SS over time
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).
Measured: up to 96 weeks (Part B)
Change from baseline in aINCAT over time
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).
Measured: up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in EQ-5D-5L over time
EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome).
Measured: up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in RT-FSS over time
Rasch-Transformed Fatigue Severity Scale (RT-FSS) is a patient-reported outcome measure to distinguish fatigue from clinical depression.
Measured: up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in SF-12 over time
12-Item Short Form Health Survey (SF-12) is a general patient-reported outcome measure.
Measured: up to 24 weeks (Part A) + 96 weeks (Part B)
Change from baseline in BPI-SF over time
The Brief Pain Inventory-Short Form (BPI-SF) is a patient-reported outcome measure to assess pain severity and pain interference.
Measured: up to 24 weeks (Part A) + 96 weeks (Part B)
PGI-S values over time
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.
Measured: up to 24 weeks (Part A) + 96 weeks (Part B)
PGI-C values over time
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.
Measured: up to 24 weeks (Part A) + 96 weeks (Part B)
Values for work-related and household chore activities of the HRPQ
The Health-Related Productivity Questionnaire (HRPQ) assesses health-related and work-related productivity, with questions related to 'hours lost because of absenteeism'.
Measured: up to 24 weeks
Percentage of scheduled hours lost in total (absenteeism+ presenteeism)
Measured: up to 24 weeks
Change from baseline in I-RODS centile points score over time
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).
Measured: Up to 96 weeks (Part B)
Change from baseline in TUG over time
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.
Measured: Up to 96 weeks (Part B)
Incidence of antidrug antibodies against empasiprubart in serum
Measured: up to 24 weeks (Part A) + 96 weeks (Part B)
Incidence of neutralizing antibodies against empasiprubart in serum
Measured: up to 24 weeks (Part A) + 96 weeks (Part B)
Incidence of (serious) adverse events
Measured: up to 24 weeks (Part A) + 96 weeks (Part B)
Percentage change from baseline in free C2 and total C2 over time
Measured: up to 24 weeks (Part A) + 96 weeks (Part B)
Serum concentrations of empasiprubart over time
Measured: up to 24 weeks (Part A) + 96 weeks (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start22 Aug 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920004
- Sponsor's protocol ID
- ARGX-117-2401
- Other IDs
- 2024-520097-36-00
- Acronym
- emvigorate
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No