Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Korábbi kezelés

• Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.

Más betegség

• 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.

• Have met clinical diagnostic criteria for typical CIDP (including incomplete 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) ± corticosteroid therapy (either low dose oral corticosteroids or pulse 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.