IMVT-1402 in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT ID: NCT07032662
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
162 participants
INTERVENTIONAL
2025-03-18
2030-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IMVT-1402
IMVT-1402
Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)
Placebo
Placebo
Matching placebo SC QW for 24 weeks (Period 1)
Interventions
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IMVT-1402
Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)
Placebo
Matching placebo SC QW for 24 weeks (Period 1)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Immunovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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Site Number - 1612
Tucson, Arizona, United States
Site Number - 1618
Carlsbad, California, United States
Site Number - 1619
Orange, California, United States
Site Number - 1607
Rancho Mirage, California, United States
Site Number -1608
San Francisco, California, United States
Site Number - 1626
Parker, Colorado, United States
Site Number - 1621
New Haven, Connecticut, United States
Site Number - 1630
Washington D.C., District of Columbia, United States
Site Number - 1601
Washington D.C., District of Columbia, United States
Site Number - 1603
Maitland, Florida, United States
Site Number - 1606
Miami, Florida, United States
Site Number - 1617
Ormond Beach, Florida, United States
Site Number - 1620
Port Charlotte, Florida, United States
Site Number - 1633
Rockledge, Florida, United States
Site Number - 1602
Kansas City, Kansas, United States
Site Number - 1611
Nicholasville, Kentucky, United States
Site Number - 1623
Boston, Massachusetts, United States
Site Number - 1625
Worcester, Massachusetts, United States
Site Number - 1629
Detroit, Michigan, United States
Site Number - 1605
New York, New York, United States
Site Number - 1627
New York, New York, United States
Site Number - 1635
Chapel Hill, North Carolina, United States
Site Number - 1610
Charlotte, North Carolina, United States
Site Number - 1624
Canton, Ohio, United States
Site Number - 1631
Yukon, Oklahoma, United States
Site Number - 1614
Portland, Oregon, United States
Site Number - 1616
Philadelphia, Pennsylvania, United States
Site Number - 1622
Houston, Texas, United States
Site Number - 1628
San Antonio, Texas, United States
Site Number - 1613
Milwaukee, Wisconsin, United States
Site Number - 5002
Buenos Aires, , Argentina
Site Number - 5001
Córdoba, , Argentina
Site Number - 5003
Córdoba, , Argentina
Site Number - 5000
Rosario, , Argentina
Site Number - 5102
Brisbane, , Australia
Site Number - 5100
Macquarie Park, , Australia
Site Number - 5103
Parkville, , Australia
Site Number - 5200
Vienna, , Austria
Site Number - 5300
Leuven, , Belgium
Site Number - 5400
Banja Luka, , Bosnia and Herzegovina
Site Number - 5402
Bihać, , Bosnia and Herzegovina
Site Number - 5401
Mostar, , Bosnia and Herzegovina
Site Number - 5403
Sarajevo, , Bosnia and Herzegovina
Site Number - 5506
Brasília, , Brazil
Site Number - 5503
Campinas, , Brazil
Site Number - 5500
Curitiba, , Brazil
Site Number - 5502
Joinville, , Brazil
Site Number - 5501
Porto Alegre, , Brazil
Site Number - 5504
Porto Alegre, , Brazil
Site Number - 5505
Vila Clementino, , Brazil
Site Number - 5601
Pleven, , Bulgaria
Site Number - 5600
Sofia, , Bulgaria
Site Number - 5602
Sofia, , Bulgaria
Site Number - 5603
Sofia, , Bulgaria
Site Number - 5604
Sofia, , Bulgaria
Site Number - 5800
Bogotá, , Colombia
Site Number - 3600
Copenhagen, , Denmark
Site Number - 3601
Odense, , Denmark
Site Number - 7251
Tallinn, , Estonia
Site Number - 3800
Turku, , Finland
Site Number - 6505
Berlin, , Germany
Site Number - 6501
Bochum, , Germany
Site Number - 6504
Essen, , Germany
Site Number - 6500
Tübingen, , Germany
Site Number - 6503
Ulm, , Germany
Site Number - 6502
Würzburg, , Germany
Site Number - 3901
Alexandroupoli, , Greece
Site Number - 3902
Athens, , Greece
Site Number - 3905
Chaïdári, , Greece
Site Number - 3906
Heraklion, , Greece
Site Number - 3903
Ioannina, , Greece
Site Number - 3904
Larissa, , Greece
Site Number - 3900
Pátrai, , Greece
Site Number - 7551
Budapest, , Hungary
Site Number - 7550
Kistarcsa, , Hungary
Site Number - 7552
Pécs, , Hungary
Site Number - 4100
Waterford, , Ireland
Site Number - 6004
Bergamo, , Italy
Site Number - 6007
Bologna, , Italy
Site Number - 6000
Brescia, , Italy
Site Number - 6009
Milan, , Italy
Site Number - 6001
Milan, , Italy
Site Number -6005
Milan, , Italy
Site Number - 6011
Pavia, , Italy
Site Number - 6010
Pisa, , Italy
Site Number - 6002
Roma, , Italy
Site Number - 6006
Roma, , Italy
Site Number - 6003
Siena, , Italy
Site Number - 2603
Colonia del Valle, , Mexico
Site Number - 2600
Culiacán, , Mexico
Site Number - 2602
Tlalpan, , Mexico
Site Number - 2601
Veracruz, , Mexico
Site Number - 2200
Utrecht, , Netherlands
Site Number - 2300
Oslo, , Norway
Site Number - 2401
Callao, , Peru
Site Number - 2400
Lima, , Peru
Site Number - 3007
Bydgoszcz, , Poland
Site Number - 3008
Gdansk, , Poland
Site Number - 3004
Katowice, , Poland
Site Number - 3000
Krakow, , Poland
Site Number - 3003
Krakow, , Poland
Site Number - 3001
Lublin, , Poland
Site Number - 3005
Lublin, , Poland
Site Number - 3002
Poznan, , Poland
Site Number - 3006
Warsaw, , Poland
Site Number -2902
Almada, , Portugal
Site Number - 2901
Matosinhos Municipality, , Portugal
Site Number - 2903
Vila Nova de Gaia, , Portugal
Site Number - 7503
Bucharest, , Romania
Site Number - 7500
Constanța, , Romania
Site Number - 9000
Belgrade, , Serbia
Site Number - 9003
Belgrade, , Serbia
Site Number -9002
Kragujevac, , Serbia
Site Number - 9001
Niš, , Serbia
Site Number - 2800
Martin, , Slovakia
Site Number - 2802
Prešov, , Slovakia
Site Number - 2801
Rimavská Sobota, , Slovakia
Site Number - 7351
Ljubljana, , Slovenia
Site Number - 7100
Barcelona, , Spain
Site Number - 7101
Barcelona, , Spain
Site Number - 7104
Bilbao, , Spain
Site Number - 7103
Córdoba, , Spain
Site Number - 7102
Santiago de Compostela, , Spain
Site Number - 7105
Valencia, , Spain
Site Number - 4250
Bakırköy, , Turkey (Türkiye)
Site Number - 4253
Başakşehir, , Turkey (Türkiye)
Site Number - 4255
Bursa, , Turkey (Türkiye)
Site Number - 4251
Istanbul, , Turkey (Türkiye)
Site Number - 4254
Izmir, , Turkey (Türkiye)
Site Number - 4252
Samsun, , Turkey (Türkiye)
Site Number - 7001
Bristol, , United Kingdom
Site Number - 7002
Glasgow, , United Kingdom
Site Number - 7000
Salford, , United Kingdom
Site Number - 7003
Southampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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IMVT-1402-2401
Identifier Type: -
Identifier Source: org_study_id