Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Otilimab
Granulocyte-macrophage colony-stimulating factor inhibitor
Placebo
- Placebo
Results by group
Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs)
From the first dose (week 0) to study endpoint (week 20)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MOR103 0.5 mg/kg | 100 percentage of participants | 8 | |
| MOR103 1.0 mg/kg | 100 percentage of participants | 8 | |
| MOR103 2.0 mg/kg | 88.9 percentage of participants | 9 | |
| Pooled Placebo | 100 percentage of participants | 6 | |
| MOR103 0.5 mg/kg | 75.0 percentage of participants | 8 | |
| MOR103 1.0 mg/kg | 50.0 percentage of participants | 8 | |
| MOR103 2.0 mg/kg | 33.3 percentage of participants | 9 | |
| Pooled Placebo | 83.3 percentage of participants | 6 | |
| MOR103 0.5 mg/kg | 62.5 percentage of participants | 8 | |
| MOR103 1.0 mg/kg | 12.5 percentage of participants | 8 | |
| MOR103 2.0 mg/kg | 0.0 percentage of participants | 9 | |
| Pooled Placebo | 50.0 percentage of participants | 6 | |
| MOR103 0.5 mg/kg | 0 percentage of participants | 8 | |
| MOR103 1.0 mg/kg | 12.5 percentage of participants | 8 | |
| MOR103 2.0 mg/kg | 0 percentage of participants | 9 | |
| Pooled Placebo | 16.7 percentage of participants | 6 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| MOR103 0.5 mg/kg | 8 | 0 (0.0%) | |
| MOR103 1.0 mg/kg | 8 | 1 (12.5%) | |
| MOR103 2.0 mg/kg | 9 | 0 (0.0%) | |
| Pooled Placebo | 6 | 1 (16.7%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs)
From the first dose (week 0) to study endpoint (week 20)
Safety
Other measures (7)
Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples
Baseline, week 14, week 16, and week 20/end of study
Immune responseMean Serum Concentration of MOR103 Over Time
Week 0 (dose 1) to week 20 (end of study)
How the body handles the medicineMean Maximum MOR103 Concentration (Cmax) After the First and Last MOR103 Doses
Week 0 (first dose) and week 10 (last dose)
How the body handles the medicineMean Time to Maximum MOR103 Concentration (Tmax) After the First and Last MOR103 Doses
Week 0 (first dose) and week 10 (last dose)
How the body handles the medicineAccumulation 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
Week 0 (first dose) and week 10 (last dose)
How the body handles the medicineNumber of New T1 Gadolinium-enhancing Lesions
Week 4, week 8, week 12, and week 16.
MRI lesionsNumber of New or Enlarging T2 Lesions
Week 8, week 12, and week 16.
MRI lesions
Who could take part
Relapsing and progressive · 18 to 60
Show the full criteria
Inclusion 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: 1. A patient with primary progressive MS (PPMS) 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Jan 2012
Main results due
Jan 2014
Finished
Feb 2014
Results posted
Oct 2014