Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: MOR103 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
- Incidence and severity of adverse events [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: Yes ]To determine the safety of multiple doses of MOR103 in patients with relapsing-remitting or secondary progressive MS (RRMS or SPMS. Safety will be evaluated by assessing adverse events, clinical lab data and vital signs.
- Pharmacokinetic profile [ Time Frame: Six time points up to 20 weeks ] [ Designated as safety issue: No ]Pharmacokinetic profile assessments comprise of the measuremnt of several standard PK parameters (e.g. Cmax, Tmax, t1/2)
- Potential immunogenicity of MOR103 [ Time Frame: 4 time points up 20 weeks ] [ Designated as safety issue: No ]To determine development of anti-MOR103 antibodies
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1, MOR103, experimental
Biological: MOR103 0.5 mg/kg or placebo
|
Drug: MOR103
Group1: MOR103 0.5 mg/kg or placebo iv x 6 doses
|
|
Experimental: Group 2, MOR103, experimental
Biological: MOR103 1.0 mg/kg or placebo
|
Drug: MOR103
MOR103 1.0 mg/kg or placebo iv x 6doses
|
|
Experimental: Group 3, MOR103, experimental
Biological: MOR103 2.0 mg/kg or placebo
|
Drug: MOR103
MOR103 2.0 mg/kg or placebo iv x 6 doses
|
Detailed Description:
Recent clinical studies demonstrated a possible dysregulation of the balance of pro and anti inflammatory lymphocytes, which may contribute to the pathogenesis of MS.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Outpatients with a diagnosis of RRMS or SPMS, who are currently not being treated and who have at least 1 of the following:
- 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
Key Exclusion Criteria:
- A patient with primary progressive MS (PPMS)
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
- A patient who has not stabilized, in the opinion of the investigator
- 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
- A patient with current or a history of major chronic inflammatory autoimmune diseases other than MS
- A patient with any type of infection
- Patients on chronic prophylactic or suppressive antibiotic, antifungal,or antiviral agents
- A patient with a history of tuberculosis.
- A patient with any signs of excretory hepatic or kidney dysfunction
- A patient with a positive test for Hepatitis B or Hepatitis C
Contacts and Locations| Contact: Roman P Korolkiewicz, MD, PhD | +49 89 89 927 ext 0 | roman.korolkewicz@morphosys.com |
| Germany | |
| Morphosys Investigative Site | Recruiting |
| Berlin, Germany | |
| Contact: Roman P Korolkiewicz, MD, PhD +49 89 89 927 ext 208 roman.korolkiewicz@morphosys.com | |
| Poland | |
| Morphosys Investigative Site | Recruiting |
| Gdansk, Poland | |
| Contact: Roman P Korolkiewicz, MD, PhD +498989927 ext 208 roman.korolkiewicz@morphosys.com | |
| Morphosys Investigative Site | Recruiting |
| Poznan, Poland | |
| Contact: Roman P Korolkiewicz, MD, PhD +498989927 ext 208 roman.korolkiewicz@morphosys.com | |
| United Kingdom | |
| Morhosys Investigative Site | Recruiting |
| Manchester, United Kingdom | |
| Contact: Roman P Korolkiewicz, PhD, MD +49 89 89 927 ext 208 roman.korolkiewicz@morphosys.com | |
| MorphoSys Investigative Site | Recruiting |
| Nottingham, United Kingdom | |
| Contact: Roman Korolkiewicz, MD, PhD | |
| Contact +498989927 ext 208 roman.korolkiewicz@morphosys.com | |
| Study Director: | Roman P Korolkiewicz, MD, PhD | MorphoSys AG |
More Information
No publications provided
| Responsible Party: | MorphoSys AG |
| ClinicalTrials.gov Identifier: | NCT01517282 History of Changes |
| Other Study ID Numbers: | 2011-001064-22 |
| Study First Received: | January 10, 2012 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Paul-Ehrlich-Institut Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013