Clinical trial NCT03737812: A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis (MS)
Keywords: Progressive multiple sclerosis
Elezanumab
ABT-555
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-11-13
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Mean Overall Response Score (ORS)
timeFrame: Week 52
Secondary outcomes:
measure: Disability Improvement Response Rate
timeFrame: Week 52
measure: Overall Response Score (ORS)
timeFrame: Week 12
measure: Overall Response Score (ORS)
timeFrame: Week 24
measure: Overall Response Score (ORS)
timeFrame: Week 36
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Josephs Hospital and Med Center /ID# 202809
state: Arizona
city: Berkeley
country: United States
facility: Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 202448
state: California
city: Carlsbad
country: United States
facility: The Research Center of Southern California /ID# 202802
state: California
city: Hanford
country: United States
facility: Vladimir Royter MD /ID# 202483
state: California
city: Palo Alto
country: United States
facility: Stanford MS Center /ID# 202445
state: California
city: Sacramento
country: United States
facility: UC Davis Health-Neurological Surgery /ID# 202485
state: California
city: San Francisco
country: United States
facility: UCSF School of Medicine - Neurology /ID# 203194
state: California
city: Aurora
country: United States
facility: University of Colorado School of Medicine, Dept of Neurology /ID# 202807
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, LLC /ID# 203072
state: Colorado
city: Lenexa
country: United States
facility: Rowe Neurology Institute /ID# 202744
state: Kansas
city: Baltimore
country: United States
facility: Duplicate_Parexel International /ID# 202747
state: Maryland
city: Lutherville
country: United States
facility: International Neurorehabilitation Institute /ID# 213333
state: Maryland
city: Farmington Hills
country: United States
facility: Michigan Institute for Neurological Disorders (MIND) /ID# 202470
state: Michigan
city: Owosso
country: United States
facility: Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206327
state: Michigan
city: Chaska
country: United States
facility: Ridgeview Specialty Clinic Chaska - Neurology /ID# 204384
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 202899
state: Missouri
city: Saint Louis
country: United States
facility: The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205432
state: Missouri
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Cent /ID# 204744
state: Nevada
city: Oklahoma City
country: United States
facility: Oklahoma Med Res. Foundation /ID# 203442
state: Oklahoma
city: Portland
country: United States
facility: Providence Neurological Specialties - West /ID# 203193
state: Oregon
city: Franklin
country: United States
facility: Advanced Neurosciences Institute /ID# 204555
state: Tennessee
city: Franklin
country: United States
facility: KCA Neurology - Franklin /ID# 202912
state: Tennessee
city: Dallas
country: United States
facility: Neurology Consultants of Dallas - LBJ Fwy /ID# 203102
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology Consul /ID# 203108
state: Texas
city: Alexandria
country: United States
facility: Integrated Neurology Services /ID# 202743
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Neuroscience Institute /ID# 204205
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center /ID# 205439
state: Washington
city: Seattle
country: United States
facility: Swedish MS Center /ID# 202904
state: Washington
city: Morgantown
country: United States
facility: West Virginia Univ School Med /ID# 202849
state: West Virginia
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital /ID# 202618
state: Wisconsin
city: Vancouver
country: Canada
facility: University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 203536
state: British Columbia
city: London
country: Canada
facility: Duplicate_London Health Sciences Centre - University Hospital /ID# 203538
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 203058
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto - St. Michael's Hospital /ID# 206213
state: Ontario
city: Greenfield Park
country: Canada
facility: Recherche Sepmus Inc. /ID# 212852
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 203869
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Institut /ID# 203868
state: Quebec
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: