drugset / Trial / NCT01517282

Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis

NCT01517282

Phase 1/2 Completed 32 enrolled MorphoSys AG
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2012-01
Primary completion
2014-01
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Otilimab Monoclonal antibody 0.5 mg/kg
Subject Otilimab Monoclonal antibody 1 mg/kg
Subject Otilimab Monoclonal antibody 2 mg/kg

Indications