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.

Stopped earlyPhase 1Relapsing and progressiveNCT01435993

What it found

Stopped

The trial ended early for another reason (see below).

This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Ozanezumab

    Reticulon-4 inhibitor

Placebo

  • Saline placebo

What it measured

Main measures

  • Safety

    every 2-4 weeks over 7 months

    RelapsesSafety

Other measures (3)

  • Cmax values and AUC(0-∞)

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

    How the body handles the medicine

  • Immunogenicity of GSK1223249 in MS patients

    Predose; Day 85; Day169; Day197

    Immune response

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

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

    Blood or spinal fluid markersHow the body handles the medicine

Who could take part

Relapsing and progressive · 18 to 60

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Sept 2011

      2. Main results due

        Jan 2012

      3. Finished

        Jan 2012

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