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

Immunovant

Status and phase

Enrolling

Phase 2

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Treatments

Drug: IMVT-1402

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07032662

IMVT-1402-2401

Details and patient eligibility

About

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

Full 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.

Enrollment

162 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.