Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01435993
First received: August 25, 2011
Last updated: May 10, 2012
Last verified: May 2012

August 25, 2011
May 10, 2012
September 2011
November 2012   (final data collection date for primary outcome measure)
Safety [ Time Frame: every 2-4 weeks over 7 months ] [ Designated as safety issue: Yes ]
• Changes in vital signs, ECG monitoring, blood chemistry, haematology, urinalysis, monitoring of AEs and MS relapses (number, incidence, severity)
Same as current
Complete list of historical versions of study NCT01435993 on ClinicalTrials.gov Archive Site
  • Cmax values and AUC(0-∞) [ Time Frame: Pre-dose; 1hr; 6hr; 12hr; 48hr; Day7; Day13; Follow-up ] [ Designated as safety issue: No ]
    Profile of Pharamcokinetics
  • Immunogenicity of GSK1223249 in MS patients [ Time Frame: Predose; Day 85; Day169; Day197 ] [ Designated as safety issue: No ]
    • Presence of antibodies to GSK1223249 to be assessed in serum samples using validated ECL assays.
  • Pharmacokinetics of GSK1223249 in cerebro-spinal fluid (CSF) in MS patients [ Time Frame: Day7; or Day 29; or Day 35; or Day 85 ] [ Designated as safety issue: No ]
    Measurement of GSK1223249 in CSF
Same as current
Not Provided
Not Provided
 
Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis
A Randomized, Single Blind, Placebo-controlled, Single Ascending Dose/Repeat Dose Cohort Study to Assess Safety, Tolerability, Pharmacokinetics and Immunogenicity of GSK1223249 in Patients With Relapsing Forms of Multiple Sclerosis.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
  • Drug: GSK1223249
    Intravenous infusion
  • Other: Saline placebo
    placebo intravenous infusion
  • Experimental: Active
    GSK1223249 slow (60 minutes) intravenous infusion
    Intervention: Drug: GSK1223249
  • Placebo Comparator: Placebo
    Saline slow (60 minutes) intravenous infusion
    Intervention: Other: Saline placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Norway
 
NCT01435993
114840
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP