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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022664-12 | EudraCT Number |
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This study will investigate an experimental new drug, GSK1223249 in patients diagnosed with relapsing forms of multiple sclerosis. The study will specifically investigate safety (vital signs like heart rate, blood pressure, Magnetic Resonance Imaging (MRI), and other markers of health from blood samples), tolerability (any side effects that occur, if any), and pharmacokinetics (how the body processes the drug and how long the drug stays in the blood, and in cerebro-spinal fluid). The study will also investigate if patients' own immune system interacts with GSK1223249.
This study will be a randomised, placebo-controlled, single-blind (Investigator and Subject), single and repeat ascending dose protocol, in multiple sclerosis patients. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and any potential for immunogenicity of GSK1223249 (a monoclonal antibody raised against Nogo-A), given intravenously in Multiple Sclerosis patients. The study will also evaluate exploratory endpoints including para-clinical activity via magnetic resonance imaging, cerebrospinal fluid pharmacokinetics, and effect of repeat dose administration of GSK1223249 on disability. Furthermore MS symptoms, such as relapses and individual symptom severity will be closely monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | GSK1223249 slow (60 minutes) intravenous infusion |
|
| Placebo | Placebo Comparator | Saline slow (60 minutes) intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1223249 | Drug | Intravenous infusion |
| |
| Saline placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | • Changes in vital signs, ECG monitoring, blood chemistry, haematology, urinalysis, monitoring of AEs and MS relapses (number, incidence, severity) | every 2-4 weeks over 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax values and AUC(0-∞) | Profile of Pharamcokinetics | Pre-dose; 1hr; 6hr; 12hr; 48hr; Day7; Day13; Follow-up |
| Immunogenicity of GSK1223249 in MS patients | • Presence of antibodies to GSK1223249 to be assessed in serum samples using validated ECL assays. |
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Inclusion Criteria:
Diagnosed with a relapsing form of MS .
Using one of the following ongoing MS treatment strategies, defined as
Demonstrated clinical activity in 2 years prior to screening, whilst receiving current/previous treatment regimen or prior to any treatment regimen
Expanded Disability Status Scale (EDSS) score ≤6.0 at either the screening or baseline visit.
Male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent.
Body weight equal to or greater than: 50 kilogrammes
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Verona | Veneto | 37134 | Italy | ||
| GSK Investigational Site |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C000594256 | ozanezumab |
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| Other |
placebo intravenous infusion |
|
| Predose; Day 85; Day169; Day197 |
| Pharmacokinetics of GSK1223249 in cerebro-spinal fluid (CSF) in MS patients | Measurement of GSK1223249 in CSF | Day7; or Day 29; or Day 35; or Day 85 |
| Lørenskog |
| 1478 |
| Norway |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |