Phase 2
N=32
Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01517282 ↗Enrolled (actual)
32
Serious AEs
6.5%
Results posted
Oct 2014
Primary outcome: Primary: Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs) — 100; 100; 88.9; 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MOR103 (Biological); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- MorphoSys AG
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs) |
100; 100; 88.9; 100; 75.0; 50.0 | — |
| SECONDARY Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Mean Serum Concentration of MOR103 Over Time |
0; 3.778; 0; 7.686; 17.907; 34.834 | — |
| SECONDARY Mean Maximum MOR103 Concentration (Cmax) After the First and Last MOR103 Doses |
8.60; 18.70; 35.67; 9.03; 22.53; 40.37 | — |
| SECONDARY Mean Time to Maximum MOR103 Concentration (Tmax) After the First and Last MOR103 Doses |
1.89; 1.49; 1.39; 2.03; 1.44; 1.31 | — |
| SECONDARY Accumulation Ratio for Area Under the MOR103 Serum Concentration Versus Time Curve (AUC) Over One Dosing Interval: Ratio of Week 10 (Last Dose) AUC to Week 0 (First Dose) AUC |
1.20; 1.31; 1.32 | — |
| SECONDARY Number of New T1 Gadolinium-enhancing Lesions |
8; 1; 1; 4; 3; 2 | — |
| SECONDARY Number of New or Enlarging T2 Lesions |
23; 3; 2; 9; 9; 3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01517282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.