Recruiting
Phase 2

IMVT-1402

Sponsor:

Immunovant Sciences GmbH

Code:

NCT07032662

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Imeroprubart

Placebo

Study Details

Brief summary:

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

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Study ID

NCT07032662

Start date

Mar 18, 2025

Status verified date

Aug, 2026

Completion date

May, 2030

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Additional inclusion criteria are defined in the protocol.

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

Study Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Imeroprubart

placebo comparator: Placebo

Interventions

Imeroprubart

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)

Primary outcome measure

  • Proportion of participants remaining Relapse-free by Week 24 [ Time Frame: Baseline, Week 24 ]

Central Contacts and Locations

Central contacts

Study Contact

18007970414clinicaltrials@immunovant.com

Locations

Site Number - 1612

Recruiting

Tucson, Arizona, United States, 85718

Site Number - 1618

Recruiting

Carlsbad, California, United States, 92011

Site Number - 1637

Recruiting

Mission Hills, California, United States, 91345

Site Number - 1619

Recruiting

Orange, California, United States, 92868

Site Number - 1607

Recruiting

Rancho Mirage, California, United States, 92270

Site Number -1608

Recruiting

San Francisco, California, United States, 94109

Site Number - 1626

Recruiting

Parker, Colorado, United States, 80138

Site Number - 1621

Recruiting

New Haven, Connecticut, United States, 06511

Site Number - 1630

Recruiting

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

Site Number - 1601

Recruiting

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

Site Number - 1603

Recruiting

Maitland, Florida, United States, 32751

Site Number - 1606

Recruiting

Miami, Florida, United States, 33136

Site Number - 1617

Recruiting

Ormond Beach, Florida, United States, 32174

Site Number - 1620

Recruiting

Port Charlotte, Florida, United States, 33952

Site Number - 1633

Recruiting

Rockledge, Florida, United States, 32955

Site Number - 1632

Recruiting

Chicago, Illinois, United States, 60637-1443

Site Number - 1602

Recruiting

Kansas City, Kansas, United States, 66205

Site Number - 1611

Recruiting

Nicholasville, Kentucky, United States, 40356

Site Number - 1623

Recruiting

Boston, Massachusetts, United States, 02114

Site Number - 1625

Recruiting

Worcester, Massachusetts, United States, 01655

Site Number - 1629

Recruiting

Detroit, Michigan, United States, 48201

Site Number - 1634

Recruiting

Las Vegas, Nevada, United States, 89106

Site Number - 1605

Recruiting

New York, New York, United States, 10032

Site Number - 1627

Recruiting

New York, New York, United States, 10065

Site Number - 1610

Recruiting

Charlotte, North Carolina, United States, 28204

Site Number - 1631

Recruiting

Yukon, Oklahoma, United States, 73099

Site Number - 1614

Recruiting

Portland, Oregon, United States, 97239

Site Number - 1616

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Site Number - 1622

Recruiting

Houston, Texas, United States, 77030

Site Number - 1628

Recruiting

San Antonio, Texas, United States, 78229

Site Number - 1613

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Immunovant Sciences GmbH

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Immunovant Sciences GmbH on 2026-08-21.