Last updated: 11/21/2020 12:10:37

Multiple doses of Anti-NOGO A in relapsing forms of Multiple Sclerosis

GSK study ID
114840
See study documents
Clinicaltrials.gov ID
NCT01435993
EudraCT ID
2010-022664-12
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Safety

Timeframe: every 2-4 weeks over 7 months

Secondary outcomes:

Cmax values and AUC(0-∞)

Timeframe: Pre-dose; 1hr; 6hr; 12hr; 48hr; Day7; Day13; Follow-up

Immunogenicity of GSK1223249 in MS patients

Timeframe: Predose; Day 85; Day169; Day197

Pharmacokinetics of GSK1223249 in cerebro-spinal fluid (CSF) in MS patients

Timeframe: Day7; or Day 29; or Day 35; or Day 85

Interventions:
  • Drug: GSK1223249
  • Other: Saline placebo
    • Enrollment:
    3
    Primary completion date:
    2012-23-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Multiple Sclerosis, Relapsing-Remitting
    Product
    ozanezumab
    Collaborators
    Not applicable
    Study date(s)
    September 2011 to January 2012
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 years
    Accepts healthy volunteers
    No
    • Diagnosed with a relapsing form of MS .
    • Using one of the following ongoing MS treatment strategies, defined as
    • 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
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosed with a relapsing form of MS .
    • Using one of the following ongoing MS treatment strategies, defined as a.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 b.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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Lørenskog, Norway, 1478
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Verona, Veneto, Italy, 37134
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Other
    Actual primary completion date
    2012-23-01
    Actual study completion date
    2012-23-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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    Access to clinical trial data by researchers
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