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Recruiting
NCT07032662
Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 162
Sponsor: Immunovant Sciences GmbH
Location: Site Number - 1612 Tucson Arizona
Summary
This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.
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.
Source: ClinicalTrials.gov (NCT07032662). StuddyBuddy aggregates publicly available trial information.