RECRUITING

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

Description

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

Study Overview

Study Details

Study overview

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

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

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

Condition
Chronic Inflammatory Demyelinating Polyneuropathy
Intervention / Treatment

-

Contacts and Locations

Tucson

Site Number - 1612, Tucson, Arizona, United States, 85718

Carlsbad

Site Number - 1618, Carlsbad, California, United States, 92011

Orange

Site Number - 1619, Orange, California, United States, 92868

Rancho Mirage

Site Number - 1607, Rancho Mirage, California, United States, 92270

San Francisco

Site Number -1608, San Francisco, California, United States, 94109

Castle Rock

Site Number - 1626, Castle Rock, Colorado, United States, 80109

New Haven

Site Number - 1621, New Haven, Connecticut, United States, 06510

Washington

Site Number - 1630, Washington, District of Columbia, United States, 20010

Washington

Site Number - 1601, Washington, District of Columbia, United States, 20037

Maitland

Site Number - 1603, Maitland, Florida, United States, 32751

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Immunovant Sciences GmbH,

Study Record Dates

2030-05