Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis
NCT01517282 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2014-11-21
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.
Conditions
Interventions
- BIOLOGICAL
-
MOR103
Anti-GM-CSF monoclonal antibody
- OTHER
-
Placebo
Placebo to anti-GM-CSF monoclonal antibody
Sponsors & Collaborators
-
MorphoSys AG
lead INDUSTRY
Principal Investigators
-
Roman P Korolkiewicz, MD, PhD · MorphoSys AG
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2014-01-31
- Completion
- 2014-02-28
Countries
- Germany
- Poland
- United Kingdom
Study Locations
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