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

NCT ID: NCT07032662

Last Updated: 2025-12-26

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-18

Study Completion Date

2030-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

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Chronic Inflammatory Demyelinating Polyneuropathy IMVT-1402 Monoclonal antibody Human immunoglobulin G1 (IgG1) CIDP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Sponsor, care provider and outcome assessor will also be blinded.

Study Groups

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IMVT-1402

Group Type EXPERIMENTAL

IMVT-1402

Intervention Type DRUG

Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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)

Intervention Type DRUG

Placebo

Matching placebo SC QW for 24 weeks (Period 1)

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immunovant Sciences GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site Number - 1612

Tucson, Arizona, United States

Site Status RECRUITING

Site Number - 1618

Carlsbad, California, United States

Site Status RECRUITING

Site Number - 1619

Orange, California, United States

Site Status RECRUITING

Site Number - 1607

Rancho Mirage, California, United States

Site Status RECRUITING

Site Number -1608

San Francisco, California, United States

Site Status NOT_YET_RECRUITING

Site Number - 1626

Parker, Colorado, United States

Site Status RECRUITING

Site Number - 1621

New Haven, Connecticut, United States

Site Status RECRUITING

Site Number - 1630

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Site Number - 1601

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Site Number - 1603

Maitland, Florida, United States

Site Status RECRUITING

Site Number - 1606

Miami, Florida, United States

Site Status NOT_YET_RECRUITING

Site Number - 1617

Ormond Beach, Florida, United States

Site Status RECRUITING

Site Number - 1620

Port Charlotte, Florida, United States

Site Status RECRUITING

Site Number - 1633

Rockledge, Florida, United States

Site Status RECRUITING

Site Number - 1602

Kansas City, Kansas, United States

Site Status RECRUITING

Site Number - 1611

Nicholasville, Kentucky, United States

Site Status RECRUITING

Site Number - 1623

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Site Number - 1625

Worcester, Massachusetts, United States

Site Status RECRUITING

Site Number - 1629

Detroit, Michigan, United States

Site Status NOT_YET_RECRUITING

Site Number - 1605

New York, New York, United States

Site Status NOT_YET_RECRUITING

Site Number - 1627

New York, New York, United States

Site Status RECRUITING

Site Number - 1635

Chapel Hill, North Carolina, United States

Site Status NOT_YET_RECRUITING

Site Number - 1610

Charlotte, North Carolina, United States

Site Status NOT_YET_RECRUITING

Site Number - 1624

Canton, Ohio, United States

Site Status NOT_YET_RECRUITING

Site Number - 1631

Yukon, Oklahoma, United States

Site Status RECRUITING

Site Number - 1614

Portland, Oregon, United States

Site Status NOT_YET_RECRUITING

Site Number - 1616

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Site Number - 1622

Houston, Texas, United States

Site Status RECRUITING

Site Number - 1628

San Antonio, Texas, United States

Site Status RECRUITING

Site Number - 1613

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Site Number - 5002

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Site Number - 5001

Córdoba, , Argentina

Site Status NOT_YET_RECRUITING

Site Number - 5003

Córdoba, , Argentina

Site Status NOT_YET_RECRUITING

Site Number - 5000

Rosario, , Argentina

Site Status NOT_YET_RECRUITING

Site Number - 5102

Brisbane, , Australia

Site Status NOT_YET_RECRUITING

Site Number - 5100

Macquarie Park, , Australia

Site Status NOT_YET_RECRUITING

Site Number - 5103

Parkville, , Australia

Site Status NOT_YET_RECRUITING

Site Number - 5200

Vienna, , Austria

Site Status NOT_YET_RECRUITING

Site Number - 5300

Leuven, , Belgium

Site Status RECRUITING

Site Number - 5400

Banja Luka, , Bosnia and Herzegovina

Site Status NOT_YET_RECRUITING

Site Number - 5402

Bihać, , Bosnia and Herzegovina

Site Status NOT_YET_RECRUITING

Site Number - 5401

Mostar, , Bosnia and Herzegovina

Site Status NOT_YET_RECRUITING

Site Number - 5403

Sarajevo, , Bosnia and Herzegovina

Site Status NOT_YET_RECRUITING

Site Number - 5506

Brasília, , Brazil

Site Status NOT_YET_RECRUITING

Site Number - 5503

Campinas, , Brazil

Site Status NOT_YET_RECRUITING

Site Number - 5500

Curitiba, , Brazil

Site Status NOT_YET_RECRUITING

Site Number - 5502

Joinville, , Brazil

Site Status NOT_YET_RECRUITING

Site Number - 5501

Porto Alegre, , Brazil

Site Status NOT_YET_RECRUITING

Site Number - 5504

Porto Alegre, , Brazil

Site Status NOT_YET_RECRUITING

Site Number - 5505

Vila Clementino, , Brazil

Site Status NOT_YET_RECRUITING

Site Number - 5601

Pleven, , Bulgaria

Site Status NOT_YET_RECRUITING

Site Number - 5600

Sofia, , Bulgaria

Site Status NOT_YET_RECRUITING

Site Number - 5602

Sofia, , Bulgaria

Site Status NOT_YET_RECRUITING

Site Number - 5603

Sofia, , Bulgaria

Site Status RECRUITING

Site Number - 5604

Sofia, , Bulgaria

Site Status NOT_YET_RECRUITING

Site Number - 5800

Bogotá, , Colombia

Site Status NOT_YET_RECRUITING

Site Number - 3600

Copenhagen, , Denmark

Site Status NOT_YET_RECRUITING

Site Number - 3601

Odense, , Denmark

Site Status RECRUITING

Site Number - 7251

Tallinn, , Estonia

Site Status NOT_YET_RECRUITING

Site Number - 3800

Turku, , Finland

Site Status NOT_YET_RECRUITING

Site Number - 6505

Berlin, , Germany

Site Status NOT_YET_RECRUITING

Site Number - 6501

Bochum, , Germany

Site Status RECRUITING

Site Number - 6504

Essen, , Germany

Site Status NOT_YET_RECRUITING

Site Number - 6500

Tübingen, , Germany

Site Status NOT_YET_RECRUITING

Site Number - 6503

Ulm, , Germany

Site Status NOT_YET_RECRUITING

Site Number - 6502

Würzburg, , Germany

Site Status RECRUITING

Site Number - 3901

Alexandroupoli, , Greece

Site Status NOT_YET_RECRUITING

Site Number - 3902

Athens, , Greece

Site Status NOT_YET_RECRUITING

Site Number - 3905

Chaïdári, , Greece

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Site Number - 3906

Heraklion, , Greece

Site Status NOT_YET_RECRUITING

Site Number - 3903

Ioannina, , Greece

Site Status NOT_YET_RECRUITING

Site Number - 3904

Larissa, , Greece

Site Status NOT_YET_RECRUITING

Site Number - 3900

Pátrai, , Greece

Site Status NOT_YET_RECRUITING

Site Number - 7551

Budapest, , Hungary

Site Status NOT_YET_RECRUITING

Site Number - 7550

Kistarcsa, , Hungary

Site Status RECRUITING

Site Number - 7552

Pécs, , Hungary

Site Status RECRUITING

Site Number - 4100

Waterford, , Ireland

Site Status NOT_YET_RECRUITING

Site Number - 6004

Bergamo, , Italy

Site Status NOT_YET_RECRUITING

Site Number - 6007

Bologna, , Italy

Site Status NOT_YET_RECRUITING

Site Number - 6000

Brescia, , Italy

Site Status NOT_YET_RECRUITING

Site Number - 6009

Milan, , Italy

Site Status NOT_YET_RECRUITING

Site Number - 6001

Milan, , Italy

Site Status NOT_YET_RECRUITING

Site Number -6005

Milan, , Italy

Site Status NOT_YET_RECRUITING

Site Number - 6011

Pavia, , Italy

Site Status NOT_YET_RECRUITING

Site Number - 6010

Pisa, , Italy

Site Status NOT_YET_RECRUITING

Site Number - 6002

Roma, , Italy

Site Status NOT_YET_RECRUITING

Site Number - 6006

Roma, , Italy

Site Status NOT_YET_RECRUITING

Site Number - 6003

Siena, , Italy

Site Status NOT_YET_RECRUITING

Site Number - 2603

Colonia del Valle, , Mexico

Site Status NOT_YET_RECRUITING

Site Number - 2600

Culiacán, , Mexico

Site Status NOT_YET_RECRUITING

Site Number - 2602

Tlalpan, , Mexico

Site Status NOT_YET_RECRUITING

Site Number - 2601

Veracruz, , Mexico

Site Status NOT_YET_RECRUITING

Site Number - 2200

Utrecht, , Netherlands

Site Status NOT_YET_RECRUITING

Site Number - 2300

Oslo, , Norway

Site Status NOT_YET_RECRUITING

Site Number - 2401

Callao, , Peru

Site Status NOT_YET_RECRUITING

Site Number - 2400

Lima, , Peru

Site Status NOT_YET_RECRUITING

Site Number - 3007

Bydgoszcz, , Poland

Site Status RECRUITING

Site Number - 3008

Gdansk, , Poland

Site Status NOT_YET_RECRUITING

Site Number - 3004

Katowice, , Poland

Site Status RECRUITING

Site Number - 3000

Krakow, , Poland

Site Status NOT_YET_RECRUITING

Site Number - 3003

Krakow, , Poland

Site Status NOT_YET_RECRUITING

Site Number - 3001

Lublin, , Poland

Site Status RECRUITING

Site Number - 3005

Lublin, , Poland

Site Status NOT_YET_RECRUITING

Site Number - 3002

Poznan, , Poland

Site Status RECRUITING

Site Number - 3006

Warsaw, , Poland

Site Status NOT_YET_RECRUITING

Site Number -2902

Almada, , Portugal

Site Status NOT_YET_RECRUITING

Site Number - 2901

Matosinhos Municipality, , Portugal

Site Status NOT_YET_RECRUITING

Site Number - 2903

Vila Nova de Gaia, , Portugal

Site Status NOT_YET_RECRUITING

Site Number - 7503

Bucharest, , Romania

Site Status NOT_YET_RECRUITING

Site Number - 7500

Constanța, , Romania

Site Status NOT_YET_RECRUITING

Site Number - 9000

Belgrade, , Serbia

Site Status NOT_YET_RECRUITING

Site Number - 9003

Belgrade, , Serbia

Site Status NOT_YET_RECRUITING

Site Number -9002

Kragujevac, , Serbia

Site Status NOT_YET_RECRUITING

Site Number - 9001

Niš, , Serbia

Site Status NOT_YET_RECRUITING

Site Number - 2800

Martin, , Slovakia

Site Status NOT_YET_RECRUITING

Site Number - 2802

Prešov, , Slovakia

Site Status NOT_YET_RECRUITING

Site Number - 2801

Rimavská Sobota, , Slovakia

Site Status NOT_YET_RECRUITING

Site Number - 7351

Ljubljana, , Slovenia

Site Status NOT_YET_RECRUITING

Site Number - 7100

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Site Number - 7101

Barcelona, , Spain

Site Status RECRUITING

Site Number - 7104

Bilbao, , Spain

Site Status NOT_YET_RECRUITING

Site Number - 7103

Córdoba, , Spain

Site Status NOT_YET_RECRUITING

Site Number - 7102

Santiago de Compostela, , Spain

Site Status NOT_YET_RECRUITING

Site Number - 7105

Valencia, , Spain

Site Status RECRUITING

Site Number - 4250

Bakırköy, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Site Number - 4253

Başakşehir, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Site Number - 4255

Bursa, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Site Number - 4251

Istanbul, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Site Number - 4254

Izmir, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Site Number - 4252

Samsun, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Site Number - 7001

Bristol, , United Kingdom

Site Status RECRUITING

Site Number - 7002

Glasgow, , United Kingdom

Site Status NOT_YET_RECRUITING

Site Number - 7000

Salford, , United Kingdom

Site Status RECRUITING

Site Number - 7003

Southampton, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Austria Belgium Bosnia and Herzegovina Brazil Bulgaria Colombia Denmark Estonia Finland Germany Greece Hungary Ireland Italy Mexico Netherlands Norway Peru Poland Portugal Romania Serbia Slovakia Slovenia Spain Turkey (Türkiye) United Kingdom

Central Contacts

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Study Contact

Role: CONTACT

Phone: 18007970414

Email: [email protected]

Other Identifiers

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IMVT-1402-2401

Identifier Type: -

Identifier Source: org_study_id