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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01517282 |
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Date of registration:
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10/01/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis
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Scientific title:
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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 |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01517282 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Germany
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Poland
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United Kingdom
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Contacts
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Name:
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Roman P Korolkiewicz, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MorphoSys AG |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Biological: MOR103
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Other: Placebo
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Primary Outcome(s)
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Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs)
[Time Frame: From the first dose (week 0) to study endpoint (week 20)]
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Secondary Outcome(s)
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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
[Time Frame: Week 0 (first dose) and week 10 (last dose)]
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Mean Maximum MOR103 Concentration (Cmax) After the First and Last MOR103 Doses
[Time Frame: Week 0 (first dose) and week 10 (last dose)]
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Mean Time to Maximum MOR103 Concentration (Tmax) After the First and Last MOR103 Doses
[Time Frame: Week 0 (first dose) and week 10 (last dose)]
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Number of New or Enlarging T2 Lesions
[Time Frame: Week 8, week 12, and week 16.]
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Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples
[Time Frame: Baseline, week 14, week 16, and week 20/end of study]
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Mean Serum Concentration of MOR103 Over Time
[Time Frame: Week 0 (dose 1) to week 20 (end of study)]
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Number of New T1 Gadolinium-enhancing Lesions
[Time Frame: Week 4, week 8, week 12, and week 16.]
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Secondary ID(s)
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2011-001064-22
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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