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

Last updated: June 16, 2025
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Peripheral Neuropathy

Treatment

Placebo

IMVT-1402

Clinical Study ID

NCT07032662
IMVT-1402-2401
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 2b study to evaluate the efficacy and safety of IMVT-1402 in adults with CIDP.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have met clinical diagnostic criteria for typical CIDP or one of the following CIDPvariants: multifocal CIDP or motor CIDP per the 2021 European Academy ofNeurology/Peripheral Nerve Society (EAN/PNS) Guideline on Diagnosis and Treatment ofCIDP.

  • Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNSguideline on diagnosis and treatment of CIDP.

  • Are currently on, and have been receiving chronic, stable doses of systemiccorticosteroids (i.e., daily or every other day oral or pulse regimen), orimmunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3months for the treatment of CIDP at the time of the Screening Visit.

Additional inclusion criteria are defined in the protocol.

Exclusion

Exclusion Criteria:

  • Have current or prior history of IgM paraproteinemia with or withoutanti-myelin-associated-glycoprotein antibodies.

  • Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy perthe 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 skinchange syndromes (i.e., POEMS)

  • Lumbosacral radiculoplexus neuropathy

  • Systemic illnesses including vitamin deficiency syndromes and paraneoplasticneuropathies

  • 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 nerveconduction study.

  • In the opinion of the Investigator, there is evidence of poorly controlled DMpreceding the diagnosis of CIDP.

  • In the opinion of the Investigator, there is evidence of poorly controlled DMat screening.

  • Have a history of myelopathy or evidence of central demyelination. Additionalexclusion criteria are defined in the protocol.

Study Design

Total Participants: 162
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 18, 2025
Estimated Completion Date:
May 31, 2030

Study Description

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.

Connect with a study center

  • Site Number - 5002

    Buenos Aires,
    Argentina

    Site Not Available

  • Site Number - 5001

    Córdoba,
    Argentina

    Site Not Available

  • Site Number - 5003

    Córdoba,
    Argentina

    Site Not Available

  • Site Number - 5000

    Rosario,
    Argentina

    Site Not Available

  • Site Number - 5102

    Brisbane,
    Australia

    Site Not Available

  • Site Number - 5100

    Macquarie Park,
    Australia

    Site Not Available

  • Site Number - 5103

    Parkville,
    Australia

    Site Not Available

  • Site Number - 5200

    Wien,
    Austria

    Site Not Available

  • Site Number - 5300

    Leuven,
    Belgium

    Site Not Available

  • Site Number - 5400

    Banja Luka,
    Bosnia and Herzegovina

    Site Not Available

  • Site Number - 5402

    Bihac,
    Bosnia and Herzegovina

    Site Not Available

  • Site Number - 5401

    Mostar,
    Bosnia and Herzegovina

    Site Not Available

  • Site Number - 5403

    Sarajevo,
    Bosnia and Herzegovina

    Site Not Available

  • Site Number - 5506

    Brasília,
    Brazil

    Site Not Available

  • Site Number - 5503

    Campinas,
    Brazil

    Site Not Available

  • Site Number - 5500

    Curitiba,
    Brazil

    Site Not Available

  • Site Number - 5502

    Joinville,
    Brazil

    Site Not Available

  • Site Number - 5501

    Porto Alegre,
    Brazil

    Site Not Available

  • Site Number - 5504

    Porto Alegre,
    Brazil

    Site Not Available

  • Site Number - 5505

    Vila Clementino,
    Brazil

    Site Not Available

  • Site Number - 5601

    Pleven,
    Bulgaria

    Site Not Available

  • Site Number - 5600

    Sofia,
    Bulgaria

    Site Not Available

  • Site Number - 5602

    Sofia,
    Bulgaria

    Site Not Available

  • Site Number - 5603

    Sofia,
    Bulgaria

    Site Not Available

  • Site Number - 5604

    Sofia,
    Bulgaria

    Site Not Available

  • Site Number - 5800

    Bogotá,
    Colombia

    Site Not Available

  • Site Number - 3600

    Copenhagen,
    Denmark

    Site Not Available

  • Site Number - 3601

    Odense,
    Denmark

    Site Not Available

  • Site Number - 7251

    Tallin,
    Estonia

    Site Not Available

  • Site Number - 3800

    Turku,
    Finland

    Site Not Available

  • Site Number - 6505

    Berlin,
    Germany

    Site Not Available

  • Site Number - 6501

    Bochum,
    Germany

    Site Not Available

  • Site Number - 6504

    Essen,
    Germany

    Site Not Available

  • Site Number - 6500

    Tübingen,
    Germany

    Site Not Available

  • Site Number - 6503

    Ulm,
    Germany

    Site Not Available

  • Site Number - 6502

    Würzburg,
    Germany

    Site Not Available

  • Site Number - 3901

    Alexandroupolis,
    Greece

    Site Not Available

  • Site Number - 3902

    Athens,
    Greece

    Site Not Available

  • Site Number - 3905

    Chaïdári,
    Greece

    Site Not Available

  • Site Number - 3906

    Heraklion,
    Greece

    Site Not Available

  • Site Number - 3903

    Ioánnina,
    Greece

    Site Not Available

  • Site Number - 3904

    Larissa,
    Greece

    Site Not Available

  • Site Number - 3900

    Patras,
    Greece

    Site Not Available

  • Site Number - 7551

    Budapest,
    Hungary

    Site Not Available

  • Site Number - 7550

    Kistarcsa,
    Hungary

    Site Not Available

  • Site Number - 7552

    Pécs,
    Hungary

    Site Not Available

  • Site Number - 4100

    Waterford,
    Ireland

    Site Not Available

  • Site Number - 6004

    Bergamo,
    Italy

    Site Not Available

  • Site Number - 6007

    Bologna,
    Italy

    Site Not Available

  • Site Number - 6000

    Brescia,
    Italy

    Site Not Available

  • Site Number - 6009

    Milan,
    Italy

    Site Not Available

  • Site Number - 6001

    Milano,
    Italy

    Site Not Available

  • Site Number -6005

    Milano,
    Italy

    Site Not Available

  • Site Number - 6011

    Pavia,
    Italy

    Site Not Available

  • Site Number - 6010

    Pisa,
    Italy

    Site Not Available

  • Site Number - 6002

    Roma,
    Italy

    Site Not Available

  • Site Number - 6006

    Roma,
    Italy

    Site Not Available

  • Site Number - 6003

    Siena,
    Italy

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  • Site Number - 2603

    Colonia Del Valle,
    Mexico

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  • Site Number - 2600

    Culiacán,
    Mexico

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  • Site Number - 2602

    Tlalpan,
    Mexico

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  • Site Number - 2601

    Veracruz,
    Mexico

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  • Site Number - 2200

    Utrecht,
    Netherlands

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  • Site Number - 2300

    Oslo,
    Norway

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  • Site Number - 2401

    Callao,
    Peru

    Site Not Available

  • Site Number - 2400

    Lima,
    Peru

    Site Not Available

  • Site Number - 3007

    Bydgoszcz,
    Poland

    Site Not Available

  • Site Number - 3008

    Gdańsk,
    Poland

    Site Not Available

  • Site Number - 3004

    Katowice,
    Poland

    Site Not Available

  • Site Number - 3000

    Kraków,
    Poland

    Site Not Available

  • Site Number - 3003

    Kraków,
    Poland

    Site Not Available

  • Site Number - 3001

    Lublin,
    Poland

    Site Not Available

  • Site Number - 3005

    Lublin,
    Poland

    Site Not Available

  • Site Number - 3002

    Poznań,
    Poland

    Site Not Available

  • Site Number - 3006

    Warszawa,
    Poland

    Site Not Available

  • Site Number -2902

    Almada,
    Portugal

    Site Not Available

  • Site Number - 2901

    Matosinhos,
    Portugal

    Site Not Available

  • Site Number - 2903

    Vila Nova De Gaia,
    Portugal

    Site Not Available

  • Site Number - 7503

    Bucuresti,
    Romania

    Site Not Available

  • Site Number - 7500

    Constanţa,
    Romania

    Site Not Available

  • Site Number - 9000

    Belgrade,
    Serbia

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  • Site Number - 9003

    Belgrade,
    Serbia

    Site Not Available

  • Site Number -9002

    Kragujevac,
    Serbia

    Site Not Available

  • Site Number - 9001

    Niš,
    Serbia

    Site Not Available

  • Site Number - 2800

    Martin,
    Slovakia

    Site Not Available

  • Site Number - 2802

    Prešov,
    Slovakia

    Site Not Available

  • Site Number - 2801

    Rimavská Sobota,
    Slovakia

    Site Not Available

  • Site Number - 7351

    Ljubljana,
    Slovenia

    Site Not Available

  • Site Number - 7100

    Barcelona,
    Spain

    Site Not Available

  • Site Number - 7101

    Barcelona,
    Spain

    Site Not Available

  • Site Number - 7104

    Bilbao,
    Spain

    Site Not Available

  • Site Number - 7103

    Córdoba,
    Spain

    Site Not Available

  • Site Number - 7102

    Santiago De Compostela,
    Spain

    Site Not Available

  • Site Number - 7105

    Valencia,
    Spain

    Site Not Available

  • Site Number - 4250

    Bakırköy,
    Turkey

    Site Not Available

  • Site Number - 4253

    Başakşehir,
    Turkey

    Site Not Available

  • Site Number - 4255

    Bursa,
    Turkey

    Site Not Available

  • Site Number - 4251

    Istanbul,
    Turkey

    Site Not Available

  • Site Number - 4252

    Samsun,
    Turkey

    Site Not Available

  • Site Number - 4254

    İzmir,
    Turkey

    Site Not Available

  • Site Number - 7001

    Bristol,
    United Kingdom

    Site Not Available

  • Site Number - 7002

    Glasgow,
    United Kingdom

    Site Not Available

  • Site Number - 7000

    Salford,
    United Kingdom

    Site Not Available

  • Site Number - 7003

    Southampton,
    United Kingdom

    Site Not Available

  • Site Number - 1612

    Tucson, Arizona 85718
    United States

    Active - Recruiting

  • Site Number - 1618

    Carlsbad, California 92011
    United States

    Active - Recruiting

  • Site Number - 1619

    Orange, California 92868
    United States

    Active - Recruiting

  • Site Number - 1607

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Site Number -1608

    San Francisco, California 94109
    United States

    Site Not Available

  • Site Number - 1626

    Castle Rock, Colorado 80109
    United States

    Site Not Available

  • Site Number - 1621

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Site Number - 1601

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Site Number - 1630

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Site Number - 1603

    Maitland, Florida 32751
    United States

    Site Not Available

  • Site Number - 1606

    Miami, Florida 33136
    United States

    Site Not Available

  • Site Number - 1617

    Ormond Beach, Florida 32174
    United States

    Active - Recruiting

  • Site Number - 1620

    Port Charlotte, Florida 33952
    United States

    Active - Recruiting

  • Site Number - 1633

    Rockledge, Florida 32955
    United States

    Active - Recruiting

  • Site Number - 1602

    Fairway, Kansas 66205
    United States

    Site Not Available

  • Site Number - 1611

    Louisville, Kentucky 40223
    United States

    Site Not Available

  • Site Number - 1623

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Site Number - 1625

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Site Number - 1629

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Site Number - 1605

    New York, New York 10032
    United States

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  • Site Number - 1627

    New York, New York 10065
    United States

    Site Not Available

  • Site Number - 1635

    Chapel Hill, North Carolina 27514
    United States

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  • Site Number - 1610

    Charlotte, North Carolina 28204
    United States

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  • Site Number - 1624

    Canton, Ohio 44718
    United States

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  • Site Number - 1631

    Yukon, Oklahoma 73099
    United States

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  • Site Number - 1614

    Portland, Oregon 97239
    United States

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  • Site Number - 1616

    Philadelphia, Pennsylvania 19107
    United States

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  • Site Number - 1622

    Houston, Texas 77030
    United States

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  • Site Number - 1628

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Site Number - 1613

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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