A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
- Registration Number
- NCT03737851
- Lead Sponsor
- AbbVie
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with relapsing Multiple Sclerosis (RMS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
- 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.
- Participants must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elezanumab Dose 2 elezanumab Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion. Placebo placebo Participants randomized to receive double-blind placebo by intravenous infusion. Elezanumab Dose 1 elezanumab Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
- Primary Outcome Measures
Name Time Method 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).
Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1.
The ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4.
- Secondary Outcome Measures
Name Time Method Overall Response Score (ORS) 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).
Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1.
The ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.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).
Trial Locations
- Locations (49)
Duplicate_Parexel International /ID# 204273
🇺🇸Baltimore, Maryland, United States
Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249
🇺🇸Berkeley, California, United States
UC Irvine Health /ID# 205728
🇺🇸Irvine, California, United States
Central Texas Neurology Consul /ID# 204268
🇺🇸Round Rock, Texas, United States
UT HSC Multiple Sclerosis Research Group - Houston /ID# 206418
🇺🇸Houston, Texas, United States
Swedish MS Center /ID# 204198
🇺🇸Seattle, Washington, United States
University of Washington Medicine MS Center /ID# 205852
🇺🇸Seattle, Washington, United States
Indiana Univ School Medicine /ID# 204891
🇺🇸Indianapolis, Indiana, United States
Dr. Bhupesh Dihenia, MD, PA /ID# 207839
🇺🇸Lubbock, Texas, United States
Virginia Mason Medical Center /ID# 205440
🇺🇸Seattle, Washington, United States
Rowe Neurology Institute /ID# 204391
🇺🇸Lenexa, Kansas, United States
Cleveland Clinic Lou Ruvo Cent /ID# 204745
🇺🇸Las Vegas, Nevada, United States
West Virginia Univ School Med /ID# 204292
🇺🇸Morgantown, West Virginia, United States
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 204844
🇨🇦Montreal, Quebec, Canada
Tri-State Mountain Neurology /ID# 204252
🇺🇸Johnson City, Tennessee, United States
The NeuroMedical Center /ID# 204253
🇺🇸Baton Rouge, Louisiana, United States
Montreal Neurological Institut /ID# 204843
🇨🇦Montreal, Quebec, Canada
University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 204841
🇨🇦Vancouver, British Columbia, Canada
KCA Neurology - Franklin /ID# 204208
🇺🇸Franklin, Tennessee, United States
Advanced Neurosciences Institute /ID# 204557
🇺🇸Franklin, Tennessee, United States
St. Josephs Hospital and Med Center /ID# 204197
🇺🇸Phoenix, Arizona, United States
Oklahoma Med Res. Foundation /ID# 204389
🇺🇸Oklahoma City, Oklahoma, United States
University of Alabama at Birmingham - Main /ID# 204618
🇺🇸Birmingham, Alabama, United States
University of Colorado School of Medicine /ID# 204250
🇺🇸Aurora, Colorado, United States
Providence Neurological Specialties - West /ID# 204248
🇺🇸Portland, Oregon, United States
Froedtert Memorial Lutheran Hospital /ID# 204202
🇺🇸Milwaukee, Wisconsin, United States
The Research Center of Southern California /ID# 204269
🇺🇸Carlsbad, California, United States
Vladimir Royter MD /ID# 204392
🇺🇸Hanford, California, United States
UCSF School of Medicine - Neurology /ID# 204251
🇺🇸San Francisco, California, 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
Pediatric Endocrine Associates /ID# 204279
🇺🇸Boston, Massachusetts, United States
International Neurorehabilitation Institute /ID# 213332
🇺🇸Lutherville, Maryland, United States
Michigan Institute for Neurological Disorders (MIND) /ID# 204194
🇺🇸Farmington Hills, Michigan, United States
Washington University-School of Medicine /ID# 204388
🇺🇸Saint Louis, Missouri, 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
The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205433
🇺🇸Saint Louis, Missouri, United States
Thomas Jefferson University /ID# 204281
🇺🇸Philadelphia, Pennsylvania, United States
Neurology Consultants of Dallas - LBJ Fwy /ID# 204398
🇺🇸Dallas, Texas, United States
Evergreen Neuroscience Institute /ID# 204203
🇺🇸Kirkland, Washington, United States
Integrated Neurology Services, PLLC /ID# 204261
🇺🇸Alexandria, Virginia, United States
Duplicate_London Health Sciences Centre - University Hospital /ID# 204848
🇨🇦London, Ontario, Canada
Unity Health Toronto - St. Michael's Hospital /ID# 206214
🇨🇦Toronto, Ontario, Canada
Ottawa Hospital Research Institute /ID# 204842
🇨🇦Ottawa, Ontario, Canada
Recherche Sepmus Inc. /ID# 212851
🇨🇦Greenfield Park, Quebec, Canada
UC Davis Health-Neurological Surgery /ID# 204188
🇺🇸Sacramento, California, United States
Ochsner Medical Center /ID# 204189
🇺🇸New Orleans, Louisiana, United States
Stanford MS Center /ID# 204283
🇺🇸Palo Alto, California, United States