CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
MOR103 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01517282
NCT01517282Phase 2Completed

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

MorphoSys AG·interventional·Posted Jan 25, 2012·Updated Nov 21, 2014

In Brief

A Phase 2 clinical trial evaluating MOR103 and Placebo for Multiple Sclerosis. Completed, enrolled 32 participants across 5 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Poland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2012
Enrollment StartJan 1, 2012
Primary CompletionJan 1, 2014
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.4 years ago

Interventions

MOR103biological

Anti-GM-CSF monoclonal antibody

Placeboother

Placebo to anti-GM-CSF monoclonal antibody