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

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT03737851
Collaborator
(none)
208
Enrollment
49
Locations
3
Arms
33
Actual Duration (Months)
4.2
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 relapsing Multiple Sclerosis (RMS).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
208 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 Relapsing Forms of Multiple Sclerosis
Actual Study Start Date :
Dec 11, 2018
Actual Primary Completion Date :
Jan 7, 2021
Actual Study Completion Date :
Sep 9, 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) at Week 52 [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:

    • Participant has diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24 months.

    • Participant has cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with multiple sclerosis (MS).

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

    Exclusion Criteria:
    • Participants must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham - Main /ID# 204618 Birmingham Alabama United States 35233
    2 St. Josephs Hospital and Med Center /ID# 204197 Phoenix Arizona United States 85013
    3 Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249 Berkeley California United States 94705-2017
    4 The Research Center of Southern California /ID# 204269 Carlsbad California United States 92011-4213
    5 Vladimir Royter MD /ID# 204392 Hanford California United States 93230-5787
    6 UC Irvine Health /ID# 205728 Irvine California United States 92697
    7 Stanford MS Center /ID# 204283 Palo Alto California United States 94304-1416
    8 UC Davis Health-Neurological Surgery /ID# 204188 Sacramento California United States 95817-2307
    9 UCSF School of Medicine - Neurology /ID# 204251 San Francisco California United States 94143-0003
    10 University of Colorado School of Medicine, Dept of Neurology /ID# 204250 Aurora Colorado United States 80045-2527
    11 Advanced Neurosciences Research, LLC /ID# 204289 Fort Collins Colorado United States 80528
    12 The University of Chicago Medical Center /ID# 205319 Chicago Illinois United States 60637-1443
    13 Indiana Univ School Medicine /ID# 204891 Indianapolis Indiana United States 46202
    14 Rowe Neurology Institute /ID# 204391 Lenexa Kansas United States 66214
    15 The NeuroMedical Center /ID# 204253 Baton Rouge Louisiana United States 70810
    16 Ochsner Medical Center /ID# 204189 New Orleans Louisiana United States 70121-2429
    17 Duplicate_Parexel International /ID# 204273 Baltimore Maryland United States 21225
    18 International Neurorehabilitation Institute /ID# 213332 Lutherville Maryland United States 21093-6016
    19 Mass General Hospital /ID# 204279 Boston Massachusetts United States 02114-4724
    20 Michigan Institute for Neurological Disorders (MIND) /ID# 204194 Farmington Hills Michigan United States 48334
    21 Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206328 Owosso Michigan United States 48867-2116
    22 Ridgeview Specialty Clinic Chaska - Neurology /ID# 204383 Chaska Minnesota United States 55318-4551
    23 Washington University School of Medicine /ID# 204388 Saint Louis Missouri United States 63110-1010
    24 The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205433 Saint Louis Missouri United States 63131-2322
    25 Cleveland Clinic Lou Ruvo Cent /ID# 204745 Las Vegas Nevada United States 89106-0100
    26 Oklahoma Med Res. Foundation /ID# 204389 Oklahoma City Oklahoma United States 73104
    27 Providence Neurological Specialties - West /ID# 204248 Portland Oregon United States 97225-6646
    28 Thomas Jefferson University /ID# 204281 Philadelphia Pennsylvania United States 19107
    29 Advanced Neurosciences Institute /ID# 204557 Franklin Tennessee United States 37064
    30 KCA Neurology - Franklin /ID# 204208 Franklin Tennessee United States 37067-5914
    31 Tri-State Mountain Neurology /ID# 204252 Johnson City Tennessee United States 37604
    32 Neurology Consultants of Dallas - LBJ Fwy /ID# 204398 Dallas Texas United States 75243-1188
    33 UT HSC Multiple Sclerosis Research Group - Houston /ID# 206418 Houston Texas United States 77030-1501
    34 Dr. Bhupesh Dihenia, MD, PA /ID# 207839 Lubbock Texas United States 79410
    35 Central Texas Neurology Consul /ID# 204268 Round Rock Texas United States 78681
    36 Integrated Neurology Services /ID# 204261 Alexandria Virginia United States 22310
    37 Evergreen Neuroscience Institute /ID# 204203 Kirkland Washington United States 98034-3029
    38 Virginia Mason - Seattle Orthapedics /ID# 205440 Seattle Washington United States 98101
    39 Swedish MS Center /ID# 204198 Seattle Washington United States 98122-5698
    40 University of Washington Medicine MS Center /ID# 205852 Seattle Washington United States 98133-8400
    41 West Virginia Univ School Med /ID# 204292 Morgantown West Virginia United States 26506
    42 Froedtert Memorial Lutheran Hospital /ID# 204202 Milwaukee Wisconsin United States 53226-3522
    43 University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 204841 Vancouver British Columbia Canada V6T 1Z3
    44 Duplicate_London Health Sciences Centre - University Hospital /ID# 204848 London Ontario Canada N6A 5A5
    45 The Ottawa Hospital /ID# 204842 Ottawa Ontario Canada K1H 8L6
    46 Unity Health Toronto - St. Michael's Hospital /ID# 206214 Toronto Ontario Canada M5B 1W8
    47 Recherche Sepmus Inc. /ID# 212851 Greenfield Park Quebec Canada J4V 2J2
    48 Crchum /Id# 204844 Montreal Quebec Canada H2X 0A9
    49 Montreal Neurological Institut /ID# 204843 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:
    NCT03737851
    Other Study ID Numbers:
    • M18-918
    First Posted:
    Nov 13, 2018
    Last Update Posted:
    Dec 7, 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
    Relapsing multiple sclerosis
    Multiple sclerosis
    Elezanumab
    ABT-555
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Dec 7, 2021