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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
Intravenous infusion
placebo intravenous infusion
GSK Investigational Site
Verona, Veneto, Italy
GSK Investigational Site
Lørenskog, Norway
Safety
• Changes in vital signs, ECG monitoring, blood chemistry, haematology, urinalysis, monitoring of AEs and MS relapses (number, incidence, severity)
Time frame: every 2-4 weeks over 7 months
Cmax values and AUC(0-∞)
Profile of Pharamcokinetics
Time frame: 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.
Time frame: Predose; Day 85; Day169; Day197
Pharmacokinetics of GSK1223249 in cerebro-spinal fluid (CSF) in MS patients
Measurement of GSK1223249 in CSF
Time frame: Day7; or Day 29; or Day 35; or Day 85
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