CompletedPhase 1Relapsing and progressiveNCT02601885

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Elezanumab

    Repulsive guidance molecule A inhibitor

Placebo or sham

  • Placebo

What it measured

Main measures

  • Number and percentage of participants reporting adverse events

    Throughout study from Day 1 to Day 176

    Safety
  • Concentration of anti-drug antibody (ADA) titers of ABT-555

    Day 1 to Day 176

    Immune response
  • Time to Maximum observed plasma concentration (Tmax) of ABT-555

    Day 1 to Day 176

    How the body handles the medicine
  • Maximum observed plasma concentration (Cmax) of ABT-555

    Day 1 to Day 176

    How the body handles the medicine
  • Area under the concentration curve (AUC) of ABT-555

    Day 1 to Day 176

    How the body handles the medicine

Other measures (4)

  • Percentage of participants who experience relapse and disability progression

    Throughout the study to Day 176

    Disability progressionRelapses
  • Lesion volume of new, newly enlarging T2 hyperintense lesions

    Throughout study from Day 0 to Day 113

    MRI lesions
  • Number of new, newly-enlarging T2 hyperintense lesions

    Throughout study from Day 0 to Day 113

    MRI lesions
  • Total number of new Gadolinium-enhancing T1 lesions

    Throughout study from Day 0 to Day 113

    MRI lesions

Who could take part

Relapsing and progressive · 18 to 60

Inclusion Criteria: * Currently receiving one of the following MS medications for at least 3 months: beta-interferon (any formulation including the pegylated form), glatiramer acetate (Copaxone®, others), teriflunomide (Aubagio®), fingolimod (Gilenya®), or dimethyl fumarate (Tecfidera®); OR * Has not been treated with an MS immunotherapy for the past 6 months (12 months if they previously received cyclophosphamide or alemtuzumab); OR * Treatment naïve with established MS diagnosis per criteria by a neurologist. * Diagnosis of relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) according to revised McDonald criteria * Baseline Expanded Disability Status Scale (EDSS) between 0 and 6.0, inclusive. * Brain MRI scan at Screening that did not show evidence of overt vascular lesions, masses, mass effect or other abnormalities other than those compatible with MS, which would preclude the participant from undergoing a lumbar puncture/spinal tap for CSF collection Exclusion Criteria: * Diagnosis of primary progressive MS. * Anticipated maintenance immunomodulator change, either agent or dose * An MS relapse that occurred within the 30 days prior to randomization AND/OR the participant has not stabilized from a previous relapse prior to randomization * Participants for whom MRI is contraindicated * Participants who have claustrophobia that cannot be medically managed or are unable to lie still for 1 hour or more for the imaging procedures * Findings on brain MRI scan indicating any clinically significant brain abnormality other than MS * Contraindication for lumbar puncture

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

About this trial

In the sponsor's words

This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      Oct 2016

    2. Main results due

      Apr 2018

    3. Finished

      Apr 2018

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