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

Study Identifier
M14-397
CT.gov Identifier
NCT03737812
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:
    * 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.

    Protocol Summary

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

    Study Locations

    Location
    Status
    Location
    St. Josephs Hospital and Med Center /ID# 202809
    Phoenix, Arizona, United States, 85013
    Status
    Not applicable
    Location
    Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 202448
    Berkeley, California, United States, 94705-2017
    Status
    Not applicable
    Location
    The Research Center of Southern California /ID# 202802
    Carlsbad, California, United States, 92011-4213
    Status
    Not applicable
    Location
    Vladimir Royter MD /ID# 202483
    Hanford, California, United States, 93230-5787
    Status
    Not applicable
    Location
    Stanford MS Center /ID# 202445
    Palo Alto, California, United States, 94304-1416
    Status
    Not applicable
    Location
    UC Davis Health-Neurological Surgery /ID# 202485
    Sacramento, California, United States, 95817-2307
    Status
    Not applicable
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