Home › Chronic Inflammatory Demyelinating Polyradiculoneuropathy › NCT07032662
Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
RecruitingPhase 2
A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Who can join
Ages 18 and older · All sexes
Full 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.
About the study
This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.
What is being tested
- Imeroprubart (drug)
- Placebo (drug)
Sponsor: Immunovant Sciences GmbH · Participants: 162 · Started: Mar 18, 2025
Contact the study team
- Study Contact · Phone: 18007970414
Official record on ClinicalTrials.gov — NCT07032662
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.