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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: March 23, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: GSK1223249
Other: Saline placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Safety [ Time Frame: every 2-4 weeks over 7 months ]
    • Changes in vital signs, ECG monitoring, blood chemistry, haematology, urinalysis, monitoring of AEs and MS relapses (number, incidence, severity)


Secondary Outcome Measures:
  • Cmax values and AUC(0-∞) [ Time Frame: Pre-dose; 1hr; 6hr; 12hr; 48hr; Day7; Day13; Follow-up ]
    Profile of Pharamcokinetics

  • Immunogenicity of GSK1223249 in MS patients [ Time Frame: Predose; Day 85; Day169; Day197 ]
    • 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 ]
    Measurement of GSK1223249 in CSF


Enrollment: 3
Study Start Date: September 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
GSK1223249 slow (60 minutes) intravenous infusion
Drug: GSK1223249
Intravenous infusion
Placebo Comparator: Placebo
Saline slow (60 minutes) intravenous infusion
Other: Saline placebo
placebo intravenous infusion

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435993

Locations
Germany
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Hamburg, Germany, 20253
Italy
GSK Investigational Site
Verona, Veneto, Italy, 37134
Norway
GSK Investigational Site
Lørenskog, Norway, 1478
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 114840
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 114840
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 114840
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 114840
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 114840
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 114840
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 114840
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01435993     History of Changes
Other Study ID Numbers: 114840
Study First Received: August 25, 2011
Last Updated: March 23, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Multiple Sclerosis, Secondary-Progressive with relapses

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 26, 2017