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Recruiting Phase 3 NCT06920004

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

Phase 3 – large-scale trial before approval
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy CIDP CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Sponsor: argenx

trial.available_in: БГ
Overview
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
Who can participate
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
Interventions
empasiprubart
BIOLOGICAL
IVIg
BIOLOGICAL
empasiprubart-placebo
OTHER
IVIg-placebo
OTHER
Locations 47
Czech Republic (1)
Fakultni nemocnice Brno
Brno
Estonia (2)
Astra Kliinik
Tallinn
Tartu University Hospital
Tartu
Germany (1)
Charité - Universitätsmedizin Berlin
Berlin
Greece (1)
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári
Israel (3)
The Barzilai University Medical Center
Ashkelon
Hadassah Medical Center- Ein Kerem
Jerusalem
The Chaim Sheba Medical Center
Tel Litwinsky
Italy (1)
AUSL di Bologna - Ospedale Bellaria
Bologna
Japan (7)
Aomori Prefectural Central Hospital
Aomori
Juntendo University Hospital
Bunkyō City
Chiba University Hospital
Chūōku
Osaka Metropolitan University Hospital
Osaka
Saga University Hospital
Saga
General Hospital Tsuchiura Kyodo Hospital
Tsuchiura
Yamaguchi University Hospital
Ube
Poland (8)
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz
Neurocentrum Bydgoszcz
Bydgoszcz
Centrum Medyczne Neurologia Slaska
Katowice
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow
Centrum Medyczne Linden
Krakow
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Poznan
Centrum Medyczne Medyk
Rzeszów
Halina Bartosik-Psujek, MD
Uniwersytecki Szpital Kliniczny Nr 1
Szczecin
Portugal (1)
ULS de Santo António, EPE - Hospital de Santo António
Porto
Romania (3)
Institutul National de Neurologie si Boli Neurovasculare Bucuresti
Bucharest
Brainaxy Clinic SRL
Constanța
Targu-Mures Emergency Clinical County Hospital
Târgu Mureş
Slovakia (1)
Univerzitna nemocnica MARTIN
Martin
Monika Turcanova Koprusakova, MD
South Korea (4)
Inje University Haeundae Paik Hospital
Busan
Seoul National University Hospital
Seoul
Severance Hospital Yonsei University Health System
Seoul
Konkuk University Medical Center
Seoul
Spain (2)
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario Vall d'Hebron
Sant Andreu de la Barca
Switzerland (1)
Hôpitaux Universitaires de Genève (HUG)
Geneva
United States (11)
University of Michigan Hospital
Ann Arbor , Michigan
University of Michigan Hospital
Ann Arbor , Michigan
Colorado Springs Neurological Associates
Colorado Springs , Colorado
Erlanger Health System
Columbia , Maryland
Homestead Associates in Research Inc
Homestead , Florida
NeuroCarePlus
Houston , Texas
National Neuromuscular Research Institute
Irving , Texas
Visionary Investigators Network
Miami , Florida
Samir Macwan, M.D., Inc.
Rancho Mirage , California
Paradigm Health System
Slidell , Louisiana
MedStar Washington Hospital Center
Washington D.C. , District of Columbia
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
22.08.2025
Completion date
01.09.2030
Registry ID
NCT06920004
Source
clinicaltrials.gov
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