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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01435993
Other study ID # 114840
Secondary ID 2010-022664-12
Status Terminated
Phase Phase 1
First received
Last updated
Start date September 8, 2011
Est. completion date January 23, 2012

Study information

Verified date November 2020
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date January 23, 2012
Est. primary completion date January 23, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Diagnosed with a relapsing form of MS . - Using one of the following ongoing MS treatment strategies, defined as 1. Currently receiving Beta-interferon/Copaxone for treatment of MS and have been receiving the current course of therapy for 3 or more months prior to screening, OR 2. Not currently receiving disease modifying therapies for treatment of MS, and has not received such therapies for at least 3 months prior to screening. - 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: - Complications/History of other diseases that may impact on safety of patients enroling into the study. - Liver function test outside normal range for patient population - Treatment with methylprednisolone or any other systemic steroid, for a relapse or otherwise, within 30 days of screening - Treatment in the past 6 months with any of the following agents: Fingolimod (Gilenya), methotrexate, mitoxantrone, azathioprine, or other small molecule immunosuppressants. - History of anaphilaxis to protein based therapeutics or mono-clonal antibodies. - Positive result for Hapatitis B, HIV, and/or drugs of abuse, or excessive alcohol consumption. - Not able to undergo MRI scanning safely, or Gadolinium (contrast enhancing agents) during MRI. - Other significant infections e.g. Tuberculosis.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GSK1223249
Intravenous infusion
Other:
Saline placebo
placebo intravenous infusion

Locations

Country Name City State
Italy GSK Investigational Site Verona Veneto
Norway GSK Investigational Site Lørenskog

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Italy,  Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Cmax values and AUC(0-8) Profile of Pharamcokinetics Pre-dose; 1hr; 6hr; 12hr; 48hr; Day7; Day13; Follow-up
Secondary Immunogenicity of GSK1223249 in MS patients • Presence of antibodies to GSK1223249 to be assessed in serum samples using validated ECL assays. Predose; Day 85; Day169; Day197
Secondary 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
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