Last updated 55 days ago

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

162 patients around the world
Available in Colombia, Peru, Brazil, Argentina, United States, Mexico
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.
Immunovant Sciences GmbH
162Patients around the world

This study is for people with

Polyneuropathy
Chronic inflammatory demyelinating polyneuropathy - CIDP

Requirements for the patient

From 18 Years
All Gender

Medical requirements

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:
Have polyneuropathy of causes other than CIDP including but not limited to: multifocal motor neuropathy.
Have polyneuropathy of causes other than CIDP including but not limited to: hereditary demyelinating neuropathy.
Have polyneuropathy of causes other than CIDP including but not limited to: polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS).
Have polyneuropathy of causes other than CIDP including but not limited to: lumbosacral radiculoplexus neuropathy.
Have polyneuropathy of causes other than CIDP including but not limited to: systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies.
Have polyneuropathy of causes other than CIDP including but not limited to: 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.
Have diabetes mellitus (DM) and meets any of the following criteria: in the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.
Have diabetes mellitus (DM) and meets any of the following criteria: 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.
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