A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
NCT ID: NCT03737851
Last Updated: 2023-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
208 participants
INTERVENTIONAL
2018-12-11
2021-09-09
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 double-blind placebo by intravenous infusion.
placebo
solution for infusion
Elezanumab Dose 1
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
elezanumab
solution for infusion
Elezanumab Dose 2
Participants randomized to receive double-blind elezanumab Dose 2 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
* 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
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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University of Alabama at Birmingham - Main /ID# 204618
Birmingham, Alabama, United States
St. Josephs Hospital and Med Center /ID# 204197
Phoenix, Arizona, United States
Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249
Berkeley, California, United States
The Research Center of Southern California /ID# 204269
Carlsbad, California, United States
Vladimir Royter MD /ID# 204392
Hanford, California, United States
UC Irvine Health /ID# 205728
Irvine, California, United States
Stanford MS Center /ID# 204283
Palo Alto, California, United States
UC Davis Health-Neurological Surgery /ID# 204188
Sacramento, California, United States
UCSF School of Medicine - Neurology /ID# 204251
San Francisco, California, United States
University of Colorado School of Medicine /ID# 204250
Aurora, Colorado, United States
Advanced Neurosciences Research, LLC /ID# 204289
Fort Collins, Colorado, United States
The University of Chicago Medical Center /ID# 205319
Chicago, Illinois, United States
Indiana Univ School Medicine /ID# 204891
Indianapolis, Indiana, United States
Rowe Neurology Institute /ID# 204391
Lenexa, Kansas, United States
The NeuroMedical Center /ID# 204253
Baton Rouge, Louisiana, United States
Ochsner Medical Center /ID# 204189
New Orleans, Louisiana, United States
Duplicate_Parexel International /ID# 204273
Baltimore, Maryland, United States
International Neurorehabilitation Institute /ID# 213332
Lutherville, Maryland, United States
Pediatric Endocrine Associates /ID# 204279
Boston, Massachusetts, United States
Michigan Institute for Neurological Disorders (MIND) /ID# 204194
Farmington Hills, Michigan, United States
Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206328
Owosso, Michigan, United States
Ridgeview Specialty Clinic Chaska - Neurology /ID# 204383
Chaska, Minnesota, United States
Washington University-School of Medicine /ID# 204388
St Louis, Missouri, United States
The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205433
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Cent /ID# 204745
Las Vegas, Nevada, United States
Oklahoma Med Res. Foundation /ID# 204389
Oklahoma City, Oklahoma, United States
Providence Neurological Specialties - West /ID# 204248
Portland, Oregon, United States
Thomas Jefferson University /ID# 204281
Philadelphia, Pennsylvania, United States
Advanced Neurosciences Institute /ID# 204557
Franklin, Tennessee, United States
KCA Neurology - Franklin /ID# 204208
Franklin, Tennessee, United States
Tri-State Mountain Neurology /ID# 204252
Johnson City, Tennessee, United States
Neurology Consultants of Dallas - LBJ Fwy /ID# 204398
Dallas, Texas, United States
UT HSC Multiple Sclerosis Research Group - Houston /ID# 206418
Houston, Texas, United States
Dr. Bhupesh Dihenia, MD, PA /ID# 207839
Lubbock, Texas, United States
Central Texas Neurology Consul /ID# 204268
Round Rock, Texas, United States
Integrated Neurology Services, PLLC /ID# 204261
Alexandria, Virginia, United States
Evergreen Neuroscience Institute /ID# 204203
Kirkland, Washington, United States
Virginia Mason Medical Center /ID# 205440
Seattle, Washington, United States
Swedish MS Center /ID# 204198
Seattle, Washington, United States
University of Washington Medicine MS Center /ID# 205852
Seattle, Washington, United States
West Virginia Univ School Med /ID# 204292
Morgantown, West Virginia, United States
Froedtert Memorial Lutheran Hospital /ID# 204202
Milwaukee, Wisconsin, United States
University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 204841
Vancouver, British Columbia, Canada
Duplicate_London Health Sciences Centre - University Hospital /ID# 204848
London, Ontario, Canada
Ottawa Hospital Research Institute /ID# 204842
Ottawa, Ontario, Canada
Unity Health Toronto - St. Michael's Hospital /ID# 206214
Toronto, Ontario, Canada
Recherche Sepmus Inc. /ID# 212851
Greenfield Park, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 204844
Montreal, Quebec, Canada
Montreal Neurological Institut /ID# 204843
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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M18-918
Identifier Type: -
Identifier Source: org_study_id