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Набира участници Фаза 2 NCT07032662

IMVT-1402 in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Chronic Inflammatory Demyelinating Polyneuropathy

Спонсор: Immunovant Sciences GmbH

Налично на: БГ
Обобщение
This is a Phase 2b study to evaluate the efficacy and safety of IMVT-1402 in adults with CIDP.
Описание
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IMVT-1402 in adult participants with active CIDP.
Кой може да участва
Inclusion Criteria: * Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) Guideline on Diagnosis and Treatment of CIDP. * Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNS guideline on diagnosis and treatment of CIDP. * Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3 months for the treatment of CIDP at the time of the Screening Visit. Additional inclusion criteria are defined in the protocol. Exclusion Criteria: * Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies. * Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN/PNS guideline on diagnosis and treatment of CIDP. * Have polyneuropathy of causes other than CIDP including but not limited to: * Multifocal motor neuropathy * Hereditary demyelinating neuropathy * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS) * Lumbosacral radiculoplexus neuropathy * Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies * Drug- or toxin-induced * Have diabetes mellitus (DM) and meets any of the following criteria: * Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study. * In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP. * In the opinion of the Investigator, there is evidence of poorly controlled DM at screening. * Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.
Интервенции
IMVT-1402
DRUG
Placebo
DRUG
Места на провеждане 135
Argentina (4)
Site Number - 5002
Buenos Aires
NOT_YET_RECRUITING
Site Number - 5001
Córdoba
Site Number - 5003
Córdoba
NOT_YET_RECRUITING
Site Number - 5000
Rosario
Австралия (3)
Site Number - 5102
Brisbane
NOT_YET_RECRUITING
Site Number - 5100
Macquarie Park
Site Number - 5103
Parkville
Австрия (1)
Site Number - 5200
Vienna
Белгия (1)
Site Number - 5300
Leuven
Bosnia and Herzegovina (4)
Site Number - 5400
Banja Luka
Site Number - 5402
Bihać
NOT_YET_RECRUITING
Site Number - 5401
Mostar
Site Number - 5403
Sarajevo
Бразилия (7)
Site Number - 5506
Brasília
Site Number - 5503
Campinas
NOT_YET_RECRUITING
Site Number - 5500
Curitiba
Site Number - 5502
Joinville
Site Number - 5501
Porto Alegre
Site Number - 5504
Porto Alegre
Site Number - 5505
Vila Clementino
България (5)
Site Number - 5601
Pleven
Site Number - 5600
Sofia
Site Number - 5602
Sofia
Site Number - 5603
Sofia
Site Number - 5604
Sofia
Colombia (1)
Site Number - 5800
Bogotá
NOT_YET_RECRUITING
Дания (2)
Site Number - 3600
Copenhagen
NOT_YET_RECRUITING
Site Number - 3601
Odense
Estonia (1)
Site Number - 7251
Tallinn
Финландия (1)
Site Number - 3800
Turku
Германия (6)
Site Number - 6505
Berlin
NOT_YET_RECRUITING
Site Number - 6501
Bochum
Site Number - 6504
Essen
NOT_YET_RECRUITING
Site Number - 6500
Tübingen
NOT_YET_RECRUITING
Site Number - 6503
Ulm
Site Number - 6502
Würzburg
Гърция (7)
Site Number - 3901
Alexandroupoli
Site Number - 3902
Athens
NOT_YET_RECRUITING
Site Number - 3905
Chaïdári
Site Number - 3906
Heraklion
NOT_YET_RECRUITING
Site Number - 3903
Ioannina
NOT_YET_RECRUITING
Site Number - 3904
Larissa
Site Number - 3900
Pátrai
Унгария (3)
Site Number - 7551
Budapest
NOT_YET_RECRUITING
Site Number - 7550
Kistarcsa
Site Number - 7552
Pécs
Ireland (1)
Site Number - 4100
Waterford
NOT_YET_RECRUITING
Италия (11)
Site Number - 6004
Bergamo
Site Number - 6007
Bologna
Site Number - 6000
Brescia
Site Number - 6009
Milan
Site Number - 6001
Milan
Site Number -6005
Milan
Site Number - 6011
Pavia
Site Number - 6010
Pisa
NOT_YET_RECRUITING
Site Number - 6002
Roma
NOT_YET_RECRUITING
Site Number - 6006
Roma
Site Number - 6003
Siena
Mexico (4)
Site Number - 2603
Colonia del Valle
NOT_YET_RECRUITING
Site Number - 2600
Culiacán
NOT_YET_RECRUITING
Site Number - 2602
Tlalpan
NOT_YET_RECRUITING
Site Number - 2601
Veracruz
NOT_YET_RECRUITING
Нидерландия (1)
Site Number - 2200
Utrecht
Норвегия (1)
Site Number - 2300
Oslo
Peru (2)
Site Number - 2401
Callao
NOT_YET_RECRUITING
Site Number - 2400
Lima
NOT_YET_RECRUITING
Полша (9)
Site Number - 3007
Bydgoszcz
Site Number - 3008
Gdansk
NOT_YET_RECRUITING
Site Number - 3004
Katowice
Site Number - 3000
Krakow
Site Number - 3003
Krakow
Site Number - 3001
Lublin
Site Number - 3005
Lublin
Site Number - 3002
Poznan
Site Number - 3006
Warsaw
NOT_YET_RECRUITING
Португалия (3)
Site Number -2902
Almada
Site Number - 2901
Matosinhos Municipality
Site Number - 2903
Vila Nova de Gaia
Румъния (2)
Site Number - 7503
Bucharest
NOT_YET_RECRUITING
Site Number - 7500
Constanța
Сърбия (4)
Site Number - 9000
Belgrade
Site Number - 9003
Belgrade
NOT_YET_RECRUITING
Site Number -9002
Kragujevac
Site Number - 9001
Niš
Словакия (3)
Site Number - 2800
Martin
NOT_YET_RECRUITING
Site Number - 2802
Prešov
Site Number - 2801
Rimavská Sobota
Словения (1)
Site Number - 7351
Ljubljana
Испания (6)
Site Number - 7100
Barcelona
Site Number - 7101
Barcelona
Site Number - 7104
Bilbao
NOT_YET_RECRUITING
Site Number - 7103
Córdoba
Site Number - 7102
Santiago de Compostela
Site Number - 7105
Valencia
Турция (6)
Site Number - 4250
Bakırköy
NOT_YET_RECRUITING
Site Number - 4253
Başakşehir
NOT_YET_RECRUITING
Site Number - 4255
Bursa
NOT_YET_RECRUITING
Site Number - 4251
Istanbul
NOT_YET_RECRUITING
Site Number - 4254
Izmir
NOT_YET_RECRUITING
Site Number - 4252
Samsun
Великобритания (4)
Site Number - 7001
Bristol
Site Number - 7002
Glasgow
NOT_YET_RECRUITING
Site Number - 7000
Salford
Site Number - 7003
Southampton
САЩ (31)
Site Number - 1623
Boston , Massachusetts
Site Number - 1624
Canton , Ohio
NOT_YET_RECRUITING
Site Number - 1618
Carlsbad , California
Site Number - 1635
Chapel Hill , North Carolina
NOT_YET_RECRUITING
Site Number - 1610
Charlotte , North Carolina
NOT_YET_RECRUITING
Site Number - 1629
Detroit , Michigan
Site Number - 1622
Houston , Texas
Site Number - 1602
Kansas City , Kansas
Site Number - 1634
Las Vegas , Nevada
Site Number - 1603
Maitland , Florida
Site Number - 1606
Miami , Florida
Site Number - 1613
Milwaukee , Wisconsin
Site Number - 1621
New Haven , Connecticut
Site Number - 1605
New York , New York
Site Number - 1627
New York , New York
Site Number - 1611
Nicholasville , Kentucky
Site Number - 1619
Orange , California
Site Number - 1617
Ormond Beach , Florida
Site Number - 1626
Parker , Colorado
Site Number - 1616
Philadelphia , Pennsylvania
Site Number - 1620
Port Charlotte , Florida
Site Number - 1614
Portland , Oregon
NOT_YET_RECRUITING
Site Number - 1607
Rancho Mirage , California
Site Number - 1633
Rockledge , Florida
Site Number - 1628
San Antonio , Texas
Site Number -1608
San Francisco , California
Site Number - 1612
Tucson , Arizona
Site Number - 1630
Washington D.C. , District of Columbia
Site Number - 1601
Washington D.C. , District of Columbia
Site Number - 1625
Worcester , Massachusetts
Site Number - 1631
Yukon , Oklahoma
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
18.03.2025
Крайна дата
01.05.2030
Регистрационен номер
NCT07032662
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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