NCT01517282

Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: MorphoSys AG · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	MOR103	Anti-GM-CSF monoclonal antibody
OTHER	Placebo	Placebo to anti-GM-CSF monoclonal antibody

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-01-01
• Completion: 2014-02-01
• First posted: 2012-01-25
• Last updated: 2014-11-21
• Results posted: 2014-10-13

Locations

5 sites across 3 countries: Germany, Poland, United Kingdom