RECRUITING

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

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Conditions

Chronic Inflammatory Demyelinating PolyneuropathyIMVT-1402Monoclonal antibodyHuman immunoglobulin G1 (IgG1)CIDP

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Quick Facts

Study Start:2025-03-18
Study Completion:2030-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07032662

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNS guideline on diagnosis and treatment of CIDP.
  3. * 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.
  1. * Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.
  2. * Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN/PNS guideline on diagnosis and treatment of CIDP.
  3. * Have polyneuropathy of causes other than CIDP including but not limited to:
  4. * Multifocal motor neuropathy
  5. * Hereditary demyelinating neuropathy
  6. * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)
  7. * Lumbosacral radiculoplexus neuropathy
  8. * Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies
  9. * Drug- or toxin-induced
  10. * Have diabetes mellitus (DM) and meets any of the following criteria:
  11. * Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study.
  12. * In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.
  13. * In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.
  14. * Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.

Contacts and Locations

Study Contact

Study Contact
CONTACT
18007970414
clinicaltrials@immunovant.com

Study Locations (Sites)

Site Number - 1612
Tucson, Arizona, 85718
United States
Site Number - 1618
Carlsbad, California, 92011
United States
Site Number - 1619
Orange, California, 92868
United States
Site Number - 1607
Rancho Mirage, California, 92270
United States
Site Number -1608
San Francisco, California, 94109
United States
Site Number - 1626
Castle Rock, Colorado, 80109
United States
Site Number - 1621
New Haven, Connecticut, 06510
United States
Site Number - 1630
Washington, District of Columbia, 20010
United States
Site Number - 1601
Washington, District of Columbia, 20037
United States
Site Number - 1603
Maitland, Florida, 32751
United States
Site Number - 1606
Miami, Florida, 33136
United States
Site Number - 1617
Ormond Beach, Florida, 32174
United States
Site Number - 1620
Port Charlotte, Florida, 33952
United States
Site Number - 1633
Rockledge, Florida, 32955
United States
Site Number - 1602
Fairway, Kansas, 66205
United States
Site Number - 1611
Louisville, Kentucky, 40223
United States
Site Number - 1623
Boston, Massachusetts, 02114
United States
Site Number - 1625
Worcester, Massachusetts, 01655
United States
Site Number - 1629
Detroit, Michigan, 48201
United States
Site Number - 1605
New York, New York, 10032
United States
Site Number - 1627
New York, New York, 10065
United States
Site Number - 1635
Chapel Hill, North Carolina, 27514
United States
Site Number - 1610
Charlotte, North Carolina, 28204
United States
Site Number - 1624
Canton, Ohio, 44718
United States
Site Number - 1631
Yukon, Oklahoma, 73099
United States
Site Number - 1614
Portland, Oregon, 97239
United States
Site Number - 1616
Philadelphia, Pennsylvania, 19107
United States
Site Number - 1622
Houston, Texas, 77030
United States
Site Number - 1628
San Antonio, Texas, 78229
United States
Site Number - 1613
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Immunovant Sciences GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-18
Study Completion Date2030-05

Study Record Updates

Study Start Date2025-03-18
Study Completion Date2030-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Chronic Inflammatory Demyelinating Polyneuropathy