A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
NCT ID: NCT03737812
Last Updated: 2023-12-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
123 participants
INTERVENTIONAL
2019-02-27
2021-08-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants randomized to receive placebo by intravenous infusion.
placebo
solution for infusion
Elezanumab 400mg Dose
Participants randomized to receive 400mg of elezanumab by intravenous infusion.
elezanumab
solution for infusion
Elezanumab 1800 mg Dose
Participants randomized to receive 1800mg of elezanumab by intravenous infusion.
elezanumab
solution for infusion
Interventions
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elezanumab
solution for infusion
placebo
solution for infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 the following within 1 year prior to Screening: cyclophosphamide or alemtuzumab.
18 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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St. Josephs Hospital and Med Center /ID# 202809
Phoenix, Arizona, United States
Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 202448
Berkeley, California, United States
The Research Center of Southern California /ID# 202802
Carlsbad, California, United States
Vladimir Royter MD /ID# 202483
Hanford, California, United States
Stanford MS Center /ID# 202445
Palo Alto, California, United States
UC Davis Health-Neurological Surgery /ID# 202485
Sacramento, California, United States
UCSF School of Medicine - Neurology /ID# 203194
San Francisco, California, United States
University of Colorado School of Medicine, Dept of Neurology /ID# 202807
Aurora, Colorado, United States
Advanced Neurosciences Research, LLC /ID# 203072
Fort Collins, Colorado, United States
Rowe Neurology Institute /ID# 202744
Lenexa, Kansas, United States
Duplicate_Parexel International /ID# 202747
Baltimore, Maryland, United States
International Neurorehabilitation Institute /ID# 213333
Lutherville, Maryland, United States
Michigan Institute for Neurological Disorders (MIND) /ID# 202470
Farmington Hills, Michigan, United States
Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206327
Owosso, Michigan, United States
Ridgeview Specialty Clinic Chaska - Neurology /ID# 204384
Chaska, Minnesota, United States
Washington University-School of Medicine /ID# 202899
St Louis, Missouri, United States
The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205432
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Cent /ID# 204744
Las Vegas, Nevada, United States
Oklahoma Med Res. Foundation /ID# 203442
Oklahoma City, Oklahoma, United States
Providence Neurological Specialties - West /ID# 203193
Portland, Oregon, United States
Advanced Neurosciences Institute /ID# 204555
Franklin, Tennessee, United States
KCA Neurology - Franklin /ID# 202912
Franklin, Tennessee, United States
Neurology Consultants of Dallas - LBJ Fwy /ID# 203102
Dallas, Texas, United States
Central Texas Neurology Consul /ID# 203108
Round Rock, Texas, United States
Integrated Neurology Services /ID# 202743
Alexandria, Virginia, United States
Evergreen Neuroscience Institute /ID# 204205
Kirkland, Washington, United States
Virginia Mason Medical Center /ID# 205439
Seattle, Washington, United States
Swedish MS Center /ID# 202904
Seattle, Washington, United States
West Virginia Univ School Med /ID# 202849
Morgantown, West Virginia, United States
Froedtert Memorial Lutheran Hospital /ID# 202618
Milwaukee, Wisconsin, United States
University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 203536
Vancouver, British Columbia, Canada
Duplicate_London Health Sciences Centre - University Hospital /ID# 203538
London, Ontario, Canada
Ottawa Hospital Research Institute /ID# 203058
Ottawa, Ontario, Canada
Unity Health Toronto - St. Michael's Hospital /ID# 206213
Toronto, Ontario, Canada
Recherche Sepmus Inc. /ID# 212852
Greenfield Park, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 203869
Montreal, Quebec, Canada
Montreal Neurological Institut /ID# 203868
Montreal, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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M14-397
Identifier Type: -
Identifier Source: org_study_id