NCT01435993

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_1

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

September 8, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2012

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

August 25, 2011

Last Update Submit

November 20, 2020

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Secondary-Progressive with relapses

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Cmax values and AUC(0-∞)

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

  • Immunogenicity of GSK1223249 in MS patients

    Predose; Day 85; Day169; Day197

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

    Day7; or Day 29; or Day 35; or Day 85

Study Arms (2)

Active

EXPERIMENTAL

GSK1223249 slow (60 minutes) intravenous infusion

Drug: GSK1223249

Placebo

PLACEBO COMPARATOR

Saline slow (60 minutes) intravenous infusion

Other: Saline placebo

Interventions

GSK1223249DRUG

Intravenous infusion

Active
Saline placeboOTHER

placebo intravenous infusion

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with a relapsing form of MS .
  • Using one of the following ongoing MS treatment strategies, defined as
  • 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
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Verona, Veneto, 37134, Italy

Location

GSK Investigational Site

Lørenskog, 1478, Norway

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

ozanezumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2011

First Posted

September 19, 2011

Study Start

September 8, 2011

Primary Completion

January 23, 2012

Study Completion

January 23, 2012

Last Updated

November 24, 2020

Record last verified: 2020-11

Locations

NO(1)IT(1)