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

NCT07032662 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IMVT-1402-2401
• Study Type: interventional
• Target: 162
• Locations: 27 countries
• Sites: 130

Brief Summary

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

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of participants remaining Relapse-free by Week 24

  Relapse is defined as a worsening (increase) of ≥ 1 point on the adjusted inflammatory neuropathy cause and treatment (aINCAT) score at any time point relative to Period 1 Baseline.

  Baseline, Week 24

Secondary Outcomes (4)

• Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS)

  Baseline and Up to Week 24

• Change from baseline to Week 24 in Mean Grip Strength in the dominant hand

  Baseline and Up to Week 24

• Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS)

  Baseline and Up to Week 24

• Change from baseline to Week 24 in aINCAT score

  Baseline and Up to Week 24

Study Arms (2)

IMVT-1402

EXPERIMENTAL

Drug: IMVT-1402

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IMVT-1402 DRUG

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

IMVT-1402

Placebo DRUG

Matching placebo SC QW for 24 weeks (Period 1)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunovant Sciences GmbH: lead

Study Sites (135)

Site Number - 1612

Tucson, Arizona, 85718, United States

RECRUITING

Site Number - 1618

Carlsbad, California, 92011, United States

RECRUITING

Site Number - 1619

Orange, California, 92868, United States

RECRUITING

Site Number - 1607

Rancho Mirage, California, 92270, United States

RECRUITING

Site Number -1608

San Francisco, California, 94109, United States

RECRUITING

Site Number - 1626

Parker, Colorado, 80138, United States

RECRUITING

Site Number - 1621

New Haven, Connecticut, 06511, United States

RECRUITING

Site Number - 1630

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Site Number - 1601

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Site Number - 1603

Maitland, Florida, 32751, United States

RECRUITING

Site Number - 1606

Miami, Florida, 33136, United States

RECRUITING

Site Number - 1617

Ormond Beach, Florida, 32174, United States

RECRUITING

Site Number - 1620

Port Charlotte, Florida, 33952, United States

RECRUITING

Site Number - 1633

Rockledge, Florida, 32955, United States

RECRUITING

Site Number - 1602

Kansas City, Kansas, 66205, United States

RECRUITING

Site Number - 1611

Nicholasville, Kentucky, 40356, United States

RECRUITING

Site Number - 1623

Boston, Massachusetts, 02114, United States

RECRUITING

Site Number - 1625

Worcester, Massachusetts, 01655, United States

RECRUITING

Site Number - 1629

Detroit, Michigan, 48201, United States

RECRUITING

Site Number - 1634

Las Vegas, Nevada, 89106, United States

RECRUITING

Site Number - 1605

New York, New York, 10032, United States

RECRUITING

Site Number - 1627

New York, New York, 10065, United States

RECRUITING

Site Number - 1635

Chapel Hill, North Carolina, 27514, United States

NOT YET RECRUITING

Site Number - 1610

Charlotte, North Carolina, 28204, United States

NOT YET RECRUITING

Site Number - 1624

Canton, Ohio, 44718, United States

NOT YET RECRUITING

Site Number - 1631

Yukon, Oklahoma, 73099, United States

RECRUITING

Site Number - 1614

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Site Number - 1616

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Site Number - 1622

Houston, Texas, 77030, United States

RECRUITING

Site Number - 1628

San Antonio, Texas, 78229, United States

RECRUITING

Site Number - 1613

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Site Number - 5002

Buenos Aires, Argentina

NOT YET RECRUITING

Site Number - 5001

Córdoba, Argentina

RECRUITING

Site Number - 5003

Córdoba, Argentina

NOT YET RECRUITING

Site Number - 5000

Rosario, Argentina

RECRUITING

Site Number - 5102

Brisbane, Australia

NOT YET RECRUITING

Site Number - 5100

Macquarie Park, Australia

RECRUITING

Site Number - 5103

Parkville, Australia

RECRUITING

Site Number - 5200

Vienna, Austria

RECRUITING

Site Number - 5300

Leuven, Belgium

RECRUITING

Site Number - 5400

Banja Luka, Bosnia and Herzegovina

RECRUITING

Site Number - 5402

Bihać, Bosnia and Herzegovina

NOT YET RECRUITING

Site Number - 5401

Mostar, Bosnia and Herzegovina

RECRUITING

Site Number - 5403

Sarajevo, Bosnia and Herzegovina

RECRUITING

Site Number - 5506

Brasília, Brazil

RECRUITING

Site Number - 5503

Campinas, Brazil

NOT YET RECRUITING

Site Number - 5500

Curitiba, Brazil

RECRUITING

Site Number - 5502

Joinville, Brazil

RECRUITING

Site Number - 5501

Porto Alegre, Brazil

RECRUITING

Site Number - 5504

Porto Alegre, Brazil

RECRUITING

Site Number - 5505

Vila Clementino, Brazil

RECRUITING

Site Number - 5601

Pleven, Bulgaria

RECRUITING

Site Number - 5600

Sofia, Bulgaria

RECRUITING

Site Number - 5602

Sofia, Bulgaria

RECRUITING

Site Number - 5603

Sofia, Bulgaria

RECRUITING

Site Number - 5604

Sofia, Bulgaria

RECRUITING

Site Number - 5800

Bogotá, Colombia

NOT YET RECRUITING

Site Number - 3600

Copenhagen, Denmark

NOT YET RECRUITING

Site Number - 3601

Odense, Denmark

RECRUITING

Site Number - 7251

Tallinn, Estonia

RECRUITING

Site Number - 3800

Turku, Finland

RECRUITING

Site Number - 6505

Berlin, Germany

NOT YET RECRUITING

Site Number - 6501

Bochum, Germany

RECRUITING

Site Number - 6504

Essen, Germany

NOT YET RECRUITING

Site Number - 6500

Tübingen, Germany

NOT YET RECRUITING

Site Number - 6503

Ulm, Germany

RECRUITING

Site Number - 6502

Würzburg, Germany

RECRUITING

Site Number - 3901

Alexandroupoli, Greece

RECRUITING

Site Number - 3902

Athens, Greece

NOT YET RECRUITING

Site Number - 3905

Chaïdári, Greece

RECRUITING

Site Number - 3906

Heraklion, Greece

NOT YET RECRUITING

Site Number - 3903

Ioannina, Greece

NOT YET RECRUITING

Site Number - 3904

Larissa, Greece

RECRUITING

Site Number - 3900

Pátrai, Greece

RECRUITING

Site Number - 7551

Budapest, Hungary

NOT YET RECRUITING

Site Number - 7550

Kistarcsa, Hungary

RECRUITING

Site Number - 7552

Pécs, Hungary

RECRUITING

Site Number - 4100

Waterford, Ireland

NOT YET RECRUITING

Site Number - 6004

Bergamo, Italy

RECRUITING

Site Number - 6007

Bologna, Italy

RECRUITING

Site Number - 6000

Brescia, Italy

RECRUITING

Site Number - 6009

Milan, Italy

RECRUITING

Site Number - 6001

Milan, Italy

RECRUITING

Site Number -6005

Milan, Italy

RECRUITING

Site Number - 6011

Pavia, Italy

RECRUITING

Site Number - 6010

Pisa, Italy

NOT YET RECRUITING

Site Number - 6002

Roma, Italy

NOT YET RECRUITING

Site Number - 6006

Roma, Italy

RECRUITING

Site Number - 6003

Siena, Italy

RECRUITING

Site Number - 2603

Colonia del Valle, Mexico

NOT YET RECRUITING

Site Number - 2600

Culiacán, Mexico

NOT YET RECRUITING

Site Number - 2602

Tlalpan, Mexico

NOT YET RECRUITING

Site Number - 2601

Veracruz, Mexico

NOT YET RECRUITING

Site Number - 2200

Utrecht, Netherlands

RECRUITING

Site Number - 2300

Oslo, Norway

RECRUITING

Site Number - 2401

Callao, Peru

NOT YET RECRUITING

Site Number - 2400

Lima, Peru

NOT YET RECRUITING

Site Number - 3007

Bydgoszcz, Poland

RECRUITING

Site Number - 3008

Gdansk, Poland

NOT YET RECRUITING

Site Number - 3004

Katowice, Poland

RECRUITING

Site Number - 3000

Krakow, Poland

RECRUITING

Site Number - 3003

Krakow, Poland

RECRUITING

Site Number - 3001

Lublin, Poland

RECRUITING

Site Number - 3005

Lublin, Poland

RECRUITING

Site Number - 3002

Poznan, Poland

RECRUITING

Site Number - 3006

Warsaw, Poland

NOT YET RECRUITING

Site Number -2902

Almada, Portugal

RECRUITING

Site Number - 2901

Matosinhos Municipality, Portugal

RECRUITING

Site Number - 2903

Vila Nova de Gaia, Portugal

RECRUITING

Site Number - 7503

Bucharest, Romania

NOT YET RECRUITING

Site Number - 7500

Constanța, Romania

RECRUITING

Site Number - 9000

Belgrade, Serbia

RECRUITING

Site Number - 9003

Belgrade, Serbia

NOT YET RECRUITING

Site Number -9002

Kragujevac, Serbia

RECRUITING

Site Number - 9001

Niš, Serbia

RECRUITING

Site Number - 2800

Martin, Slovakia

NOT YET RECRUITING

Site Number - 2802

Prešov, Slovakia

RECRUITING

Site Number - 2801

Rimavská Sobota, Slovakia

RECRUITING

Site Number - 7351

Ljubljana, Slovenia

RECRUITING

Site Number - 7100

Barcelona, Spain

RECRUITING

Site Number - 7101

Barcelona, Spain

RECRUITING

Site Number - 7104

Bilbao, Spain

NOT YET RECRUITING

Site Number - 7103

Córdoba, Spain

RECRUITING

Site Number - 7102

Santiago de Compostela, Spain

RECRUITING

Site Number - 7105

Valencia, Spain

RECRUITING

Site Number - 4250

Bakırköy, Turkey (Türkiye)

NOT YET RECRUITING

Site Number - 4253

Başakşehir, Turkey (Türkiye)

NOT YET RECRUITING

Site Number - 4255

Bursa, Turkey (Türkiye)

NOT YET RECRUITING

Site Number - 4251

Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

Site Number - 4254

Izmir, Turkey (Türkiye)

NOT YET RECRUITING

Site Number - 4252

Samsun, Turkey (Türkiye)

RECRUITING

Site Number - 7001

Bristol, United Kingdom

RECRUITING

Site Number - 7002

Glasgow, United Kingdom

NOT YET RECRUITING

Site Number - 7000

Salford, United Kingdom

RECRUITING

Site Number - 7003

Southampton, United Kingdom

RECRUITING

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Study Contact

CONTACT

18007970414; clinicaltrials@immunovant.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor, care provider and outcome assessor will also be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 24, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (7); PT (3); DK (2); RO (2); HU (3); PL (9); ES (6); ME (4); IE (1); NO (1); SL (1); GB (4); AU (3); US (31); AR (4); NL (1); GR (7); FI (1); PE (2); CO (1); DE (6); SE (4); BU (5); BE (1); BO (4); IT (11); TU (6)