Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis
NCT ID: NCT01517282
Last Updated: 2014-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2012-01-31
2014-02-28
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MOR103 0.5 mg/kg
6 doses of MOR103 0.5 mg/kg administered on Days 1 (Baseline), 15 (Visit 2), 29 (Visit 3), 43 (Visit 4), 57 (Visit 5), and 71 (Visit 6).
MOR103
Anti-GM-CSF monoclonal antibody
MOR103 1.0 mg/kg
6 doses of MOR103 1.0 mg/kg administered on Days 1 (Baseline), 15 (Visit 2), 29 (Visit 3), 43 (Visit 4), 57 (Visit 5), and 71 (Visit 6).
MOR103
Anti-GM-CSF monoclonal antibody
MOR103 2.0 mg/kg
6 doses of MOR103 2.0 mg/kg administered on Days 1 (Baseline), 15 (Visit 2), 29 (Visit 3), 43 (Visit 4), 57 (Visit 5), and 71 (Visit 6).
MOR103
Anti-GM-CSF monoclonal antibody
Placebo
6 doses of placebo administered on Days 1 (Baseline), 15 (Visit 2), 29 (Visit 3), 43 (Visit 4), 57 (Visit 5), and 71 (Visit 6).
Placebo
Placebo to anti-GM-CSF monoclonal antibody
Interventions
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MOR103
Anti-GM-CSF monoclonal antibody
Placebo
Placebo to anti-GM-CSF monoclonal antibody
Eligibility Criteria
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Inclusion Criteria
* At least 1 documented relapse within 1 year before Screening, or
* Two documented relapses within the past 2 years before Screening, or
* A new gadolinium (Gd)-enhancing lesion on magnetic resonance imaging (MRI) T1-weighted imaging within 1 year before Screening, or
* A new T2 lesion on MRI within 1 year before Screening. The patient must have 10 or less, Gd-enhancing lesions per T1-weighted MRI at Screening as assessed by a central reader.
The patient must be able and willing to ambulate, with an Expanded Disability Status Scale (EDSS) score of ≥ 2.0 and ≤ 6.5 at both the Screening Visit and the Baseline Visit
Exclusion Criteria
2. A patient who has previously received at any time any of the following
* B-cell or T-cell depleting therapies
* Cytotoxic agents, any immunosuppressive/immunomodulating agents
3. A patient who has not stabilized, in the opinion of the investigator
4. A patient with any medical condition or uncontrolled disease states other than MS requiring or likely to require systemic treatment with corticosteroids or other immune compromising agents
5. A patient with current or a history of major chronic inflammatory autoimmune diseases other than MS
6. A patient with any type of infection
7. Patients on chronic prophylactic or suppressive antibiotic, antifungal,or antiviral agents
8. A patient with a history of tuberculosis.
9. A patient with any signs of excretory hepatic or kidney dysfunction
10. A patient with a positive test for Hepatitis B or Hepatitis C
18 Years
60 Years
ALL
No
Sponsors
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MorphoSys AG
INDUSTRY
Responsible Party
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Principal Investigators
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Roman P Korolkiewicz, MD, PhD
Role: STUDY_DIRECTOR
MorphoSys AG
Locations
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Morphosys Investigative Site
Berlin, , Germany
Morphosys Investigative Site
Gdansk, , Poland
Morphosys Investigative Site
Poznan, , Poland
Morhosys Investigative Site
Manchester, , United Kingdom
MorphoSys Investigative Site
Nottingham, , United Kingdom
Countries
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Other Identifiers
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2011-001064-22
Identifier Type: -
Identifier Source: org_study_id