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

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT02601885
Collaborator
(none)
20
Enrollment
8
Locations
3
Arms
18
Actual Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
An Escalating Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
Actual Study Start Date :
Oct 18, 2016
Actual Primary Completion Date :
Apr 20, 2018
Actual Study Completion Date :
Apr 20, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 2

Participants will receive multiple doses of ABT-555 or placebo

Drug: ABT-555
Intravenous Infusion
Other Names:
  • Elezanumab

    • Other: Placebo
    Intravenous Infusion
    Experimental: Group 3

    Participants will receive multiple doses of ABT-555 or placebo

    Drug: ABT-555
    Intravenous Infusion
    Other Names:
  • Elezanumab

    • Other: Placebo
    Intravenous Infusion
    Experimental: Group 1

    Participants will receive multiple doses of ABT-555 or placebo

    Drug: ABT-555
    Intravenous Infusion
    Other Names:
  • Elezanumab

    • Other: Placebo
    Intravenous Infusion

    Outcome Measures

    Primary Outcome Measures

    1. Number and percentage of participants reporting adverse events [Throughout study from Day 1 to Day 176]

    2. Concentration of anti-drug antibody (ADA) titers of ABT-555 [Day 1 to Day 176]

    3. Time to Maximum observed plasma concentration (Tmax) of ABT-555 [Day 1 to Day 176]

    4. Maximum observed plasma concentration (Cmax) of ABT-555 [Day 1 to Day 176]

    5. Area under the concentration curve (AUC) of ABT-555 [Day 1 to Day 176]

    Secondary Outcome Measures

    1. Percentage of participants who experience relapse and disability progression [Throughout the study to Day 176]

    2. Lesion volume of new, newly enlarging T2 hyperintense lesions [Throughout study from Day 0 to Day 113]

    3. Number of new, newly-enlarging T2 hyperintense lesions [Throughout study from Day 0 to Day 113]

    4. Total number of new Gadolinium-enhancing T1 lesions [Throughout study from Day 0 to Day 113]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Compass Research LLC Orlando Florida United States 32806
    2 Rowe Neurology Institute Lenexa Kansas United States 66214
    3 Parexel International Baltimore Maryland United States 21225
    4 MIND Farmington Hills Michigan United States 48334
    5 Duke Univ Med Ctr Durham North Carolina United States 27710
    6 Tri-State Mountain Neurology Johnson City Tennessee United States 37604
    7 Clinical Trial Network Houston Texas United States 77074
    8 Integrated Neurology Services Alexandria Virginia United States 22310

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02601885
    Other Study ID Numbers:
    • M14-173
    First Posted:
    Nov 11, 2015
    Last Update Posted:
    May 17, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Relapsing-remitting
    Secondary progressive
    Relapsing forms
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of May 17, 2018