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A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT03737812
Collaborator
(none)
123
Enrollment
37
Locations
3
Arms
30.1
Actual Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
123 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
Actual Study Start Date :
Feb 27, 2019
Actual Primary Completion Date :
Jan 15, 2021
Actual Study Completion Date :
Aug 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Participants randomized to receive double-blind placebo by intravenous infusion.

Drug: placebo
solution for infusion
Experimental: Elezanumab Dose 1

Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.

Drug: elezanumab
solution for infusion
Other Names:
  • ABT-555

    		•
    Experimental: Elezanumab Dose 2

    Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.

    Drug: elezanumab
    solution for infusion
    Other Names:
  • ABT-555

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean Overall Response Score (ORS) [Week 52]

      The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).

    Secondary Outcome Measures

    1. Disability Improvement Response Rate [Week 52]

      Disability improvement response rate is assessed based on the Expanded Disability Status Scale Plus (EDSS+). EDSS+ is comprised of EDSS, Timed 25-Foot Walk (T25FW) and 9-Hole Peg Tests (9HPT).

    2. Overall Response Score (ORS) [Up to Week 36]

      The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24 months.

    • Evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.

    Exclusion Criteria:

    • Treatment with any of the following within the 6 months prior to Screening: natalizumab; cyclosporine; azathioprine; methotrexate; mycophenolate mofetil; intravenous immunoglobulin (IVIg); any interferon product; and intravenous (IV), oral, or intrathecal corticosteroids for the purposes of disease modification.

    • Treatment with the following within 1 year prior to Screening: cyclophosphamide or alemtuzumab.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Josephs Hospital and Med Center /ID# 202809 Phoenix Arizona United States 85013
    2 Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 202448 Berkeley California United States 94705-2017
    3 The Research Center of Southern California /ID# 202802 Carlsbad California United States 92011-4213
    4 Vladimir Royter MD /ID# 202483 Hanford California United States 93230-5787
    5 Stanford MS Center /ID# 202445 Palo Alto California United States 94304-1416
    6 UC Davis Health-Neurological Surgery /ID# 202485 Sacramento California United States 95817-2307
    7 UCSF School of Medicine - Neurology /ID# 203194 San Francisco California United States 94143-0003
    8 University of Colorado School of Medicine, Dept of Neurology /ID# 202807 Aurora Colorado United States 80045-2527
    9 Advanced Neurosciences Research, LLC /ID# 203072 Fort Collins Colorado United States 80528
    10 Rowe Neurology Institute /ID# 202744 Lenexa Kansas United States 66214
    11 Duplicate_Parexel International /ID# 202747 Baltimore Maryland United States 21225
    12 International Neurorehabilitation Institute /ID# 213333 Lutherville Maryland United States 21093-6016
    13 Michigan Institute for Neurological Disorders (MIND) /ID# 202470 Farmington Hills Michigan United States 48334
    14 Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206327 Owosso Michigan United States 48867-2116
    15 Ridgeview Specialty Clinic Chaska - Neurology /ID# 204384 Chaska Minnesota United States 55318-4551
    16 Washington University School of Medicine /ID# 202899 Saint Louis Missouri United States 63110-1010
    17 The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205432 Saint Louis Missouri United States 63131-2322
    18 Cleveland Clinic Lou Ruvo Cent /ID# 204744 Las Vegas Nevada United States 89106-0100
    19 Oklahoma Med Res. Foundation /ID# 203442 Oklahoma City Oklahoma United States 73104
    20 Providence Neurological Specialties - West /ID# 203193 Portland Oregon United States 97225-6646
    21 Advanced Neurosciences Institute /ID# 204555 Franklin Tennessee United States 37064
    22 KCA Neurology - Franklin /ID# 202912 Franklin Tennessee United States 37067-5914
    23 Neurology Consultants of Dallas - LBJ Fwy /ID# 203102 Dallas Texas United States 75243-1188
    24 Central Texas Neurology Consul /ID# 203108 Round Rock Texas United States 78681
    25 Integrated Neurology Services /ID# 202743 Alexandria Virginia United States 22310
    26 Evergreen Neuroscience Institute /ID# 204205 Kirkland Washington United States 98034-3029
    27 Virginia Mason - Seattle Orthapedics /ID# 205439 Seattle Washington United States 98101
    28 Swedish MS Center /ID# 202904 Seattle Washington United States 98122-5698
    29 West Virginia Univ School Med /ID# 202849 Morgantown West Virginia United States 26506
    30 Froedtert Memorial Lutheran Hospital /ID# 202618 Milwaukee Wisconsin United States 53226-3522
    31 University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 203536 Vancouver British Columbia Canada V6T 1Z3
    32 Duplicate_London Health Sciences Centre - University Hospital /ID# 203538 London Ontario Canada N6A 5A5
    33 The Ottawa Hospital /ID# 203058 Ottawa Ontario Canada K1H 8L6
    34 Unity Health Toronto - St. Michael's Hospital /ID# 206213 Toronto Ontario Canada M5B 1W8
    35 Recherche Sepmus Inc. /ID# 212852 Greenfield Park Quebec Canada J4V 2J2
    36 Crchum /Id# 203869 Montreal Quebec Canada H2X 0A9
    37 Montreal Neurological Institut /ID# 203868 Montreal Quebec Canada H3A 2B4

    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:
    NCT03737812
    Other Study ID Numbers:
    • M14-397
    First Posted:
    Nov 13, 2018
    Last Update Posted:
    Dec 20, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Progressive multiple sclerosis
    Elezanumab
    ABT-555
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Dec 20, 2021