A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Status: Recruiting
Location: See all (135) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a Phase 2b study to evaluate the efficacy and safety of IMVT-1402 in adults with CIDP.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Site Number - 1612
RECRUITING
Tucson
California
Site Number - 1618
RECRUITING
Carlsbad
Site Number - 1619
RECRUITING
Orange
Site Number - 1607
RECRUITING
Rancho Mirage
Site Number -1608
RECRUITING
San Francisco
Colorado
Site Number - 1626
RECRUITING
Parker
Connecticut
Site Number - 1621
RECRUITING
New Haven
Washington, D.c.
Site Number - 1601
RECRUITING
Washington D.c.
Site Number - 1630
RECRUITING
Washington D.c.
Florida
Site Number - 1603
RECRUITING
Maitland
Site Number - 1606
RECRUITING
Miami
Site Number - 1617
RECRUITING
Ormond Beach
Site Number - 1620
RECRUITING
Port Charlotte
Site Number - 1633
RECRUITING
Rockledge
Kansas
Site Number - 1602
RECRUITING
Kansas City
Kentucky
Site Number - 1611
RECRUITING
Nicholasville
Massachusetts
Site Number - 1623
NOT_YET_RECRUITING
Boston
Site Number - 1625
RECRUITING
Worcester
Michigan
Site Number - 1629
RECRUITING
Detroit
North Carolina
Site Number - 1635
NOT_YET_RECRUITING
Chapel Hill
Site Number - 1610
NOT_YET_RECRUITING
Charlotte
Nevada
Site Number - 1634
RECRUITING
Las Vegas
New York
Site Number - 1605
RECRUITING
New York
Site Number - 1627
RECRUITING
New York
Ohio
Site Number - 1624
NOT_YET_RECRUITING
Canton
Oklahoma
Site Number - 1631
RECRUITING
Yukon
Oregon
Site Number - 1614
NOT_YET_RECRUITING
Portland
Pennsylvania
Site Number - 1616
RECRUITING
Philadelphia
Texas
Site Number - 1622
RECRUITING
Houston
Site Number - 1628
RECRUITING
San Antonio
Wisconsin
Site Number - 1613
RECRUITING
Milwaukee
Other Locations
Argentina
Site Number - 5002
NOT_YET_RECRUITING
Buenos Aires
Site Number - 5001
RECRUITING
Córdoba
Site Number - 5003
NOT_YET_RECRUITING
Córdoba
Site Number - 5000
RECRUITING
Rosario
Australia
Site Number - 5102
NOT_YET_RECRUITING
Brisbane
Site Number - 5100
RECRUITING
Macquarie Park
Site Number - 5103
RECRUITING
Parkville
Austria
Site Number - 5200
NOT_YET_RECRUITING
Vienna
Belgium
Site Number - 5300
RECRUITING
Leuven
Bosnia and Herzegovina
Site Number - 5400
NOT_YET_RECRUITING
Banja Luka
Site Number - 5402
NOT_YET_RECRUITING
Bihać
Site Number - 5401
RECRUITING
Mostar
Site Number - 5403
NOT_YET_RECRUITING
Sarajevo
Brazil
Site Number - 5506
NOT_YET_RECRUITING
Brasília
Site Number - 5503
NOT_YET_RECRUITING
Campinas
Site Number - 5500
RECRUITING
Curitiba
Site Number - 5502
NOT_YET_RECRUITING
Joinville
Site Number - 5501
NOT_YET_RECRUITING
Porto Alegre
Site Number - 5504
RECRUITING
Porto Alegre
Site Number - 5505
RECRUITING
Vila Clementino
Bulgaria
Site Number - 5601
RECRUITING
Pleven
Site Number - 5600
RECRUITING
Sofia
Site Number - 5602
RECRUITING
Sofia
Site Number - 5603
RECRUITING
Sofia
Site Number - 5604
RECRUITING
Sofia
Colombia
Site Number - 5800
NOT_YET_RECRUITING
Bogotá
Denmark
Site Number - 3600
NOT_YET_RECRUITING
Copenhagen
Site Number - 3601
RECRUITING
Odense
Estonia
Site Number - 7251
RECRUITING
Tallinn
Finland
Site Number - 3800
RECRUITING
Turku
Germany
Site Number - 6505
NOT_YET_RECRUITING
Berlin
Site Number - 6501
RECRUITING
Bochum
Site Number - 6504
NOT_YET_RECRUITING
Essen
Site Number - 6500
NOT_YET_RECRUITING
Tübingen
Site Number - 6503
RECRUITING
Ulm
Site Number - 6502
RECRUITING
Würzburg
Greece
Site Number - 3901
RECRUITING
Alexandroupoli
Site Number - 3902
NOT_YET_RECRUITING
Athens
Site Number - 3905
RECRUITING
Chaïdári
Site Number - 3906
NOT_YET_RECRUITING
Heraklion
Site Number - 3903
NOT_YET_RECRUITING
Ioannina
Site Number - 3904
RECRUITING
Larissa
Site Number - 3900
RECRUITING
Pátrai
Hungary
Site Number - 7551
NOT_YET_RECRUITING
Budapest
Site Number - 7550
RECRUITING
Kistarcsa
Site Number - 7552
RECRUITING
Pécs
Ireland
Site Number - 4100
NOT_YET_RECRUITING
Waterford
Italy
Site Number - 6004
RECRUITING
Bergamo
Site Number - 6007
RECRUITING
Bologna
Site Number - 6000
RECRUITING
Brescia
Site Number - 6001
RECRUITING
Milan
Site Number - 6009
NOT_YET_RECRUITING
Milan
Site Number -6005
RECRUITING
Milan
Site Number - 6011
RECRUITING
Pavia
Site Number - 6010
NOT_YET_RECRUITING
Pisa
Site Number - 6002
NOT_YET_RECRUITING
Roma
Site Number - 6006
RECRUITING
Roma
Site Number - 6003
RECRUITING
Siena
Mexico
Site Number - 2603
NOT_YET_RECRUITING
Colonia Del Valle
Site Number - 2600
NOT_YET_RECRUITING
Culiacán
Site Number - 2602
NOT_YET_RECRUITING
Tlalpan
Site Number - 2601
NOT_YET_RECRUITING
Veracruz
Netherlands
Site Number - 2200
RECRUITING
Utrecht
Norway
Site Number - 2300
RECRUITING
Oslo
Peru
Site Number - 2401
NOT_YET_RECRUITING
Callao
Site Number - 2400
NOT_YET_RECRUITING
Lima
Poland
Site Number - 3007
RECRUITING
Bydgoszcz
Site Number - 3008
NOT_YET_RECRUITING
Gdansk
Site Number - 3004
RECRUITING
Katowice
Site Number - 3000
RECRUITING
Krakow
Site Number - 3003
RECRUITING
Krakow
Site Number - 3001
RECRUITING
Lublin
Site Number - 3005
RECRUITING
Lublin
Site Number - 3002
RECRUITING
Poznan
Site Number - 3006
NOT_YET_RECRUITING
Warsaw
Portugal
Site Number -2902
RECRUITING
Almada
Site Number - 2901
RECRUITING
Matosinhos Municipality
Site Number - 2903
RECRUITING
Vila Nova De Gaia
Romania
Site Number - 7503
NOT_YET_RECRUITING
Bucharest
Site Number - 7500
RECRUITING
Constanța
Serbia
Site Number - 9000
RECRUITING
Belgrade
Site Number - 9003
NOT_YET_RECRUITING
Belgrade
Site Number -9002
RECRUITING
Kragujevac
Site Number - 9001
RECRUITING
Niš
Slovakia
Site Number - 2800
NOT_YET_RECRUITING
Martin
Site Number - 2802
RECRUITING
Prešov
Site Number - 2801
RECRUITING
Rimavská Sobota
Slovenia
Site Number - 7351
RECRUITING
Ljubljana
Spain
Site Number - 7100
NOT_YET_RECRUITING
Barcelona
Site Number - 7101
RECRUITING
Barcelona
Site Number - 7104
NOT_YET_RECRUITING
Bilbao
Site Number - 7103
RECRUITING
Córdoba
Site Number - 7102
RECRUITING
Santiago De Compostela
Site Number - 7105
RECRUITING
Valencia
Turkey
Site Number - 4250
NOT_YET_RECRUITING
Bakırköy
Site Number - 4253
NOT_YET_RECRUITING
Başakşehir
Site Number - 4255
NOT_YET_RECRUITING
Bursa
Site Number - 4251
NOT_YET_RECRUITING
Istanbul
Site Number - 4254
NOT_YET_RECRUITING
Izmir
Site Number - 4252
NOT_YET_RECRUITING
Samsun
United Kingdom
Site Number - 7001
RECRUITING
Bristol
Site Number - 7002
NOT_YET_RECRUITING
Glasgow
Site Number - 7000
RECRUITING
Salford
Site Number - 7003
RECRUITING
Southampton
Contact Information
Primary
Study Contact
clinicaltrials@immunovant.com
18007970414
Time Frame
Start Date: 2025-03-18
Estimated Completion Date: 2030-05
Participants
Target number of participants: 162
Treatments
Experimental: IMVT-1402
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Immunovant Sciences GmbH