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

Launched by IMMUNOVANT SCIENCES GMBH · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called IMVT-1402 to see if it is safe and effective for adults living with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition that affects the nerves and can cause weakness and numbness. The study is currently looking for participants between the ages of 18 and 74 who have been diagnosed with typical CIDP or certain types of CIDP, and who have been on stable treatment with steroids or immunoglobulin therapy for at least three months.

If you join this study, you can expect to be carefully monitored to see how well the medication works and to check for any side effects. The trial is designed for people whose diagnosis is supported by specific nerve tests, and who do not have other types of nerve problems or certain health conditions like poorly controlled diabetes. This study offers a chance to try a new treatment that could potentially help manage CIDP symptoms, but it also involves meeting detailed criteria to ensure safety and accurate results.

Gender

ALL

Eligibility criteria

• 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.