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

Study Identifier
M18-918
CT.gov Identifier
NCT03737851
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
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Study Details

Medical Condition
  • Multiple Sclerosis (MS)
    • Study Drug
  • elezanumab
  • placebo
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    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.

    Protocol Summary

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

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham - Main /ID# 204618
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    St. Josephs Hospital and Med Center /ID# 204197
    Phoenix, Arizona, United States, 85013
    Status
    Not applicable
    Location
    Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249
    Berkeley, California, United States, 94705-2017
    Status
    Not applicable
    Location
    The Research Center of Southern California /ID# 204269
    Carlsbad, California, United States, 92011-4213
    Status
    Not applicable
    Location
    Vladimir Royter MD /ID# 204392
    Hanford, California, United States, 93230-5787
    Status
    Not applicable
    Location
    UC Irvine Health /ID# 205728
    Irvine, California, United States, 92697
    Status
    Not applicable
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