RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: argenx • ClinicalTrials.gov ID: NCT07091630

Registry updated: 2026-10-16

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Description

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

Interventions

Empasiprubart IV (Biological)
Intravenous infusion of empasiprubart
Placebo IV (Other)
Intravenous infusion of placebo

Eligibility criteria

Inclusion Criteria: * Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) * Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (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 Exclusion Criteria: * 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) * Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy CIDP Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Locations

University of Alabama at Birmingham - 1720 University Blvd — Birmingham, Alabama, United States
Samir Macwan, M.D., Inc. (S corporation) — Rancho Mirage, California, United States
Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
Medstar Health Research Institute — Washington D.C., District of Columbia, United States
Gables Neurology — Miami, Florida, United States
Aqualane Clinical Research — Naples, Florida, United States
Vero Beach Neurology and Research Institute — Vero Beach, Florida, United States
Paradigm Health System — Slidell, Louisiana, United States
Penn Medicine University City — Philadelphia, Pennsylvania, United States
Jefferson Health Honickman Center — Philadelphia, Pennsylvania, United States
University Neurology — Knoxville, Tennessee, United States
National Neuromuscular Research Institute — Austin, Texas, United States
NeuroCarePlus — Houston, Texas, United States
Instituto Privado Kremer — Córdoba, Argentina
Instituto Médico de la Fundación Estudios Clínicos — Rosario, Argentina
INECO Neurociencias Oroño — Rosario, Argentina
Kepler Universitätsklinikum Linz - Med Campus III — Linz, Upper Austria, Austria
Universitätsklinikum AKH Wien — Vienna, Austria
Escola Bahiana de Medicina e Saude Publica — Salvador, Estado de Bahia, Brazil
Unidade de Pesquisa Clinica e Inovacao da Estacio — Rio de Janeiro, Rio de Janeiro, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS — Pôrto Alegre, Rio Grande do Sul, Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - UPS - PPDS — Ribeirão Preto, São Paulo, Brazil
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME — Brasília, Brazil
Hospital Moinhos de Vento — Porto Alegre, Brazil
PSEG Centro de Pesquisa Clinica — São Paulo, Brazil
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD — Sofia, Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment — Pleven, Bulgaria
Medical Center Medika 2005 - Branch Sofia — Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD — Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD — Sofia, Bulgaria
Fujian Medical University Union Hospital - Yushan Campus — Fuzhou, Fujian, China
The People's Hospital of Baiyun District Guangzhou — Guangzhou, Guangdong, China
Peking University First Hospital - Changqiao Campus — Beijing, China
Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, China
Nanfang Hospital Southern Medical University — Guangzhou, China
Xi'an Gaoxin Hospital — Xi'an, China
Hospital Neurologico de Colombia Fundacion Ivan Jimenez - El Neurologico — Medellín, Antioquia, Colombia
Fakultni nemocnice Brno — Brno, Czechia
Rigshospitalet — Copenhagen, Denmark
Astra Kliinik — Tallinn, Estonia
CHU de Lille - Hôpital Roger Salengro — Lille, Nord, France
AP-HP - Hôpital de la Pitié Salpétrière — Paris, Paris, France
AP-HP - Hôpital Henri Mondor — Créteil, Val-de-Marne, France
CHU de Bordeaux - Hôpital — Bourdeaux, France
CHU de Nice-Hôpital Pasteur — Nice, France
High Technology Hospital MedCenter Ltd — Batumi, Georgia
First Medical Clinic LLC — Batumi, Georgia
Petre Sarajishvili Institute of Neurology — Tbilisi, Georgia
Aleksandre Aladashvili Clinic — Tbilisi, Georgia
Curatio JSC — Tbilisi, Georgia
LTD New Hospitals — Tbilisi, Georgia
Geo Hospitals — Tbilisi, Georgia
Jo Ann Medical Center — Tbilisi, Georgia
University General Hospital of Alexandroupolis — Alexandroupoli, Evros, Greece
Eginitio Hospital — Athens, Greece
Semmelweis Egyetem Genomikai Medicina és Ritka Betegségek Intézete — Budapest, Hungary
Hillel Yaffe Medical Center — Hadera, Israel
The Chaim Sheba Medical Center - PPDS — Ramat Gan, Israel
Fondazione Serena Onlus - Centro Clinico NeMO Brescia — Gussago, Brescia, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara — Trieste, Friuli-VeneziaGiulia, Italy
IRCCS Istituto delle Scienze Neurologiche di Bologna — Bologna, Italy
IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino — Genova, Italy
Ospedale San Raffaele S.r.l. — Milan, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS — Pavia, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara — Trieste, Italy
Institute of Science Tokyo Hospital — Bunkyō-Ku, Tokyo, Japan
Seirei Hamamatsu Hospital — Hiroshima, Japan
Southern TOHOKU Medical Clinic — Kōriyama, Japan
Saga University Hospital — Saga, Japan
Institutul de Neurologie si Neurochirurgie — Chisinau, Moldova
Institutul de Neurologie si Neurochirurgie — Chisinau, Moldova
Universitair Medisch Centrum Utrecht — Utrecht, Netherlands
Centrum Medyczne Neurologia Slaska — Katowice, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie — Krakow, Poland
Galen Clinic - Warszawa — Warsaw, Poland
Regina Maria Brasov Hospital — Brasov, Romania
S.C. Neurocity S.R.L — Bucharest, Romania
SC Clubul Sanatatii SRL — Campulung Muscel, Romania
Spitalul Judetean de Urgenta Deva — Deva, Romania
National Neuroscience Institute — Singapore, Singapore
Univerzitna nemocnica MARTIN — Martin, Slovakia
Nemocnica s poliklinikou S. Kukuru a.s. - Pentahospitals — Michalovce, Slovakia
Penta Hospitals SK, a.s. - Rimavská Sobota — Rimavská Sobota, Slovakia
Seoul National University Hospital — Seoul, South Korea
Korea University Guro Hospital — Seoul, South Korea
Kent and Canterbury Hospital — Canterbury, Kent, United Kingdom
Queen's Medical Centre — Nottingham, Nottinghamshire, United Kingdom
The National Hospital for Neurology and Neurosurgery - PPDS — London, United Kingdom
Salford Royal Hospital — Salford, United Kingdom

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Official Source

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

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