A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
- Registration Number
- NCT03737812
- Lead Sponsor
- AbbVie
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo Participants randomized to receive placebo by intravenous infusion. Elezanumab 400mg Dose elezanumab Participants randomized to receive 400mg of elezanumab by intravenous infusion. Elezanumab 1800 mg Dose elezanumab Participants randomized to receive 1800mg of elezanumab by intravenous infusion.
- Primary Outcome Measures
Name Time Method Mean Overall Response Score (ORS) 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 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 Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW) and 9-Hole Peg Tests (9HPT).
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.
Trial Locations
- Locations (37)
Central Texas Neurology Consul /ID# 203108
🇺🇸Round Rock, Texas, United States
Montreal Neurological Institut /ID# 203868
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 203869
🇨🇦Montreal, Quebec, Canada
West Virginia Univ School Med /ID# 202849
🇺🇸Morgantown, West Virginia, United States
KCA Neurology - Franklin /ID# 202912
🇺🇸Franklin, Tennessee, United States
Michigan Institute for Neurological Disorders (MIND) /ID# 202470
🇺🇸Farmington Hills, Michigan, United States
UCSF School of Medicine - Neurology /ID# 203194
🇺🇸San Francisco, California, United States
Advanced Neurosciences Institute /ID# 204555
🇺🇸Franklin, Tennessee, United States
Washington University-School of Medicine /ID# 202899
🇺🇸Saint Louis, Missouri, United States
International Neurorehabilitation Institute /ID# 213333
🇺🇸Lutherville, Maryland, United States
Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206327
🇺🇸Owosso, Michigan, United States
The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205432
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Cent /ID# 204744
🇺🇸Las Vegas, Nevada, United States
Ridgeview Specialty Clinic Chaska - Neurology /ID# 204384
🇺🇸Chaska, Minnesota, United States
Ottawa Hospital Research Institute /ID# 203058
🇨🇦Ottawa, Ontario, Canada
Vladimir Royter MD /ID# 202483
🇺🇸Hanford, California, United States
Duplicate_Parexel International /ID# 202747
🇺🇸Baltimore, Maryland, United States
Advanced Neurosciences Research, LLC /ID# 203072
🇺🇸Fort Collins, Colorado, United States
Rowe Neurology Institute /ID# 202744
🇺🇸Lenexa, Kansas, United States
Integrated Neurology Services /ID# 202743
🇺🇸Alexandria, Virginia, United States
Recherche Sepmus Inc. /ID# 212852
🇨🇦Greenfield Park, Quebec, Canada
Duplicate_London Health Sciences Centre - University Hospital /ID# 203538
🇨🇦London, Ontario, Canada
Stanford MS Center /ID# 202445
🇺🇸Palo Alto, California, 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
Neurology Consultants of Dallas - LBJ Fwy /ID# 203102
🇺🇸Dallas, Texas, United States
Virginia Mason Medical Center /ID# 205439
🇺🇸Seattle, Washington, United States
Swedish MS Center /ID# 202904
🇺🇸Seattle, Washington, United States
University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 203536
🇨🇦Vancouver, British Columbia, Canada
Unity Health Toronto - St. Michael's Hospital /ID# 206213
🇨🇦Toronto, Ontario, Canada
St. Josephs Hospital and Med Center /ID# 202809
🇺🇸Phoenix, Arizona, United States
UC Davis Health-Neurological Surgery /ID# 202485
🇺🇸Sacramento, California, United States
Providence Neurological Specialties - West /ID# 203193
🇺🇸Portland, Oregon, United States
Froedtert Memorial Lutheran Hospital /ID# 202618
🇺🇸Milwaukee, Wisconsin, United States
University of Colorado School of Medicine, Dept of Neurology /ID# 202807
🇺🇸Aurora, Colorado, United States
Oklahoma Med Res. Foundation /ID# 203442
🇺🇸Oklahoma City, Oklahoma, United States
Evergreen Neuroscience Institute /ID# 204205
🇺🇸Kirkland, Washington, United States