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Completed

NCT Number: NCT02601885

A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Compass Research LLC, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-555

Drug

Intravenous Infusion

Other names: Elezanumab

Placebo

Other

Intravenous Infusion

Primary outcomes

  1. Number and percentage of participants reporting adverse events

    Time frame: Throughout study from Day 1 to Day 176

  2. Concentration of anti-drug antibody (ADA) titers of ABT-555

    Time frame: Day 1 to Day 176

  3. Time to Maximum observed plasma concentration (Tmax) of ABT-555

    Time frame: Day 1 to Day 176

  4. Maximum observed plasma concentration (Cmax) of ABT-555

    Time frame: Day 1 to Day 176

  5. Area under the concentration curve (AUC) of ABT-555

    Time frame: Day 1 to Day 176

Secondary outcomes

  1. Percentage of participants who experience relapse and disability progression

    Time frame: Throughout the study to Day 176

  2. Lesion volume of new, newly enlarging T2 hyperintense lesions

    Time frame: Throughout study from Day 0 to Day 113

  3. Number of new, newly-enlarging T2 hyperintense lesions

    Time frame: Throughout study from Day 0 to Day 113

  4. Total number of new Gadolinium-enhancing T1 lesions

    Time frame: Throughout study from Day 0 to Day 113

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Escalating Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 11, 2015
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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