Multiple Sclerosis Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety and Pharmacokinetics of MOR103, a Human Antibody to GM-CSF, in Patients With Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory disease associated with central nervous
system (CNS) demyelination and subsequent axonal degeneration. Multiple sclerosis exhibits
an unpredictable and variable clinical course.
Multiple sclerosis plaques contain numerous types of cells and infiltrating macrophages have
been identified to contribute significantly to demyelination in both clinical MS and animal
models of MS. Granulocyte-macrophage colony-stimulating factor (GM CSF) stimulates
proliferation and activation of macrophages, monocytes, neutrophils, eosinophils, dendritic
cells and microglia with subsequent induction of proinflammatory biomolecules.
Therefore blocking GM CSF activity might be a therapeutic approach for the treatment of MS.
Recent clinical studies demonstrated a possible dysregulation of the balance of pro and anti
inflammatory lymphocytes, which may contribute to the pathogenesis of MS.
It was shown in animal models of EAE that during the disease effect or phase GM CSF
sustained neuroinflammation via myeloid cells that infiltrate the CNS proving an essential
role of GM CSF in encephalitogenicity.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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