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NCT07091630RecruitingPhase 3

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

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo 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/emnergize

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
160 (estimated)
First submitted
22 Jul 2025
Start date
16 Sept 2025
Primary completion date
7 Oct 2027
Lead sponsor
argenx
NCT number
NCT07091630
EU CT number
2025-520805-10-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 160
  • From 16 Sept 2025 to the primary completion date, 7 Oct 2027
  • 98 sites in 27 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.

Prior treatment

  • Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation

Other

  • Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
  • Sensory CIDP (including sensory-predominant CIDP)
  • Polyneuropathy of other causes
  • Clinical diagnosis of systemic lupus erythematosus (SLE)

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 (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
  • Has residual disability and active disease
  • Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)
  • Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP

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

Full criteria on ClinicalTrials.gov

Sites (98)

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
Instituto Médico de la Fundación Estudios Clínicos
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RosarioArgentinaRecruiting
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
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
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PlevenBulgariaRecruiting
Alexandrovska University Hospital
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SofiaBulgariaRecruiting
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
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SofiaBulgariaRecruiting
Medical Center Medica 2005 EOOD
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SofiaBulgariaRecruiting
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
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SofiyaBulgariaRecruiting
L2 Ip Instituto de Pesquisas Clinicas Ltda ME
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BrasíliaBrazilRecruiting
Hospital de Clinicas de Porto Alegre HCPA PPDS
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Porto AlegreBrazilRecruiting
Hospital Moinhos de Vento
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Porto AlegreBrazilRecruiting
Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - UPS - PPDS
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Ribeirão PretoBrazilRecruiting
Unidade de Pesquisa Clinica e Inovacao da Estacio
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Rio de JaneiroBrazilRecruiting
Escola Bahiana de Medicina e Saude Publica
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SalvadorBrazilRecruiting
PSEG Centro de Pesquisa Clinica
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São PauloBrazilRecruiting
Peking University First Hospital - Changqiao Campus
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BeijingChinaRecruiting
Fujian Medical University Union Hospital - Yushan Campus
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FuzhouChinaRecruiting
Nanfang Hospital, Southern Medical University
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GuangzhouChinaRecruiting
Guangdong Provincial Hospital of Chinese Medicine
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GuangzhouChinaRecruiting
The People's Hospital of Baiyun District Guangzhou
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GuangzhouChinaRecruiting
Xi'an Gaoxin Hospital
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Xi’anChinaRecruiting
Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico
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MedellínColombiaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Rigshospitalet
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Copenhagen OeDenmarkRecruiting
Clinic4U OÜ
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TallinnEstoniaRecruiting
Pohjois-Pohjanmaan hyvinvointialue
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OuluFinlandNot yet recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceRecruiting
Assistance Publique Hopitaux De Paris
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CreteilFranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Kent and Canterbury Hospital
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CanterburyUnited KingdomRecruiting
The National Hospital for Neurology and Neurosurgery - PPDS
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LondonUnited KingdomRecruiting
Queen'S Medical Centre
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NottinghamUnited KingdomRecruiting
Salford Royal Hospital
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SalfordUnited KingdomRecruiting
High Technology Hospital Medcenter LTD
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BatumiGeorgiaRecruiting
First Medical Clinic LLC
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BatumiGeorgiaRecruiting
Jo Ann Medical Center
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TbilisiGeorgiaRecruiting
Aleksandre Aladashvili Clinic
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TbilisiGeorgiaRecruiting
Curatio, Jsc
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TbilisiGeorgiaRecruiting
Geo Hospitals
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TbilisiGeorgiaRecruiting
Petre Sarajishvili Institute of Neurology
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TbilisiGeorgiaRecruiting
LTD "New Hospitals"
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TbilisiGeorgiaRecruiting
University General Hospital of Alexandroupoli
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AlexandroupoliGreeceRecruiting
Eginitio Hospital
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AthensGreeceRecruiting
Clinexpert Kft.
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Budapest IIIHungaryRecruiting
Semmelweis University
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Budapest VIIIHungaryRecruiting
Hillel Yaffe Medical Center
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HaderaIsraelRecruiting
The Chaim Sheba Medical Center - PPDS
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Ramat GanIsraelRecruiting
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyRecruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyRecruiting
Centro Clinico Nemo
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GussagoItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
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NaplesItalyRecruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyRecruiting
Azienda Sanitaria Universitaria Giuliano Isontina
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TriesteItalyRecruiting
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyRecruiting
Institute of Science Tokyo Hospital
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Bunkyo-kuJapanRecruiting
Seirei Hamamatsu Hospital
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HiroshimaJapanRecruiting
Southern TOHOKU Medical Clinic
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KōriyamaJapanRecruiting
Saga University Hospital
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SagaJapanRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Korea University Guro Hospital
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SeoulSouth KoreaRecruiting
Institutul de Neurologie si Neurochirurgie
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ChisinauMoldovaRecruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandRecruiting
Neurologia Śląska Centrum Medyczne
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KatowicePolandRecruiting
Galen Clinic
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LublinPolandRecruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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WarsawPolandRecruiting
Galen Clinic
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WarszawaPolandRecruiting
Centrul Medical Unirea S.R.L.
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BrasovRomaniaRecruiting
Neurocity S.R.L.
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BucharestRomaniaRecruiting
Clubul Sanatatii S.R.L.
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CampulungRomaniaRecruiting
Spitalul Judetean de Urgenta Deva
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DevaRomaniaRecruiting
National Neuroscience Institute
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SingaporeSingaporeRecruiting
University Medical Center Ljubljana
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LjubljanaSloveniaRecruiting
Univerzitna nemocnica Martin
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MartinSlovakiaRecruiting
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
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MichalovceSlovakiaRecruiting
Penta hospitals SK, a.s.
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Rimavská SobotaSlovakiaRecruiting
National Neuromuscular Research Institute
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AustinUnited StatesRecruiting
University of Alabama at Birmingham - 1720 University Blvd
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BirminghamUnited StatesRecruiting
Colorado Springs Neurological Associates
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Colorado SpringsUnited StatesRecruiting
NeuroCarePlus
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HoustonUnited StatesRecruiting
University Neurology
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KnoxvilleUnited StatesRecruiting
Gables Neurology
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MiamiUnited StatesRecruiting
Aqualane Clinical Research
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NaplesUnited StatesRecruiting
Jefferson Health Honickman Center
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PhiladelphiaUnited StatesRecruiting
Penn Medicine University City
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PhiladelphiaUnited StatesRecruiting
Samir Macwan, M.D., Inc. (S corporation)
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Rancho MirageUnited StatesRecruiting
Paradigm Health System
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SlidellUnited StatesRecruiting
Vero Beach Neurology and Research Institute
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Vero BeachUnited StatesRecruiting
Medstar Health Research Institute
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Washington D.C.United StatesRecruiting

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