Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis

NCT01517282 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-11-21

Study results available
· View outcomes & findings →

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01517282 on ClinicalTrials.gov