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

Purpose

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

Condition

  • Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Sponsor, care provider and outcome assessor will also be blinded.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IMVT-1402
  • Drug: IMVT-1402
    Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)
Placebo Comparator
Placebo
  • Drug: Placebo
    Matching placebo SC QW for 24 weeks (Period 1)

Recruiting Locations

Site Number - 1612
Tucson 5318313, Arizona 5551752 85718

Site Number - 1618
Carlsbad 5334223, California 5332921 92011

Site Number - 1619
Orange 5379513, California 5332921 92868

Site Number - 1607
Rancho Mirage 5386015, California 5332921 92270

Site Number - 1626
Parker 5434006, Colorado 5417618 80138

Site Number - 1621
New Haven 4839366, Connecticut 4831725 06511

Site Number - 1630
Washington D.C. 4140963, District of Columbia 4138106 20010

Site Number - 1601
Washington D.C. 4140963, District of Columbia 4138106 20037

Site Number - 1603
Maitland 4163220, Florida 4155751 32751

Site Number - 1617
Ormond Beach 4167178, Florida 4155751 32174

Site Number - 1620
Port Charlotte 4169130, Florida 4155751 33952

Site Number - 1633
Rockledge 4170358, Florida 4155751 32955

Site Number - 1602
Kansas City 4273837, Kansas 4273857 66205

Site Number - 1611
Nicholasville 4302561, Kentucky 6254925 40356

Site Number - 1625
Worcester 4956184, Massachusetts 6254926 01655

Site Number - 1627
New York 5128581, New York 5128638 10065

Site Number - 1631
Yukon 4556165, Oklahoma 4544379 73099

Site Number - 1616
Philadelphia 4560349, Pennsylvania 6254927 19107

Site Number - 1622
Houston 4699066, Texas 4736286 77030

Site Number - 1628
San Antonio 4726206, Texas 4736286 78229

Site Number - 1613
Milwaukee 5263045, Wisconsin 5279468 53226

More Details

NCT ID
NCT07032662
Status
Recruiting
Sponsor
Immunovant Sciences GmbH

Study Contact

Study Contact
18007970414
clinicaltrials@immunovant.com

Detailed 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.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center