Clinical trial NCT03737851: A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing 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 Relapsing Forms of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis (MS)
Keywords: Relapsing multiple sclerosis
Multiple sclerosis
Elezanumab
ABT-555
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-11-13
Enrollment: 208
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 relapsing Multiple Sclerosis (RMS).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

- Participants must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening.

Primary outcomes:
measure: Mean Overall Response Score (ORS) at Week 52
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: Birmingham
country: United States
facility: University of Alabama at Birmingham - Main /ID# 204618
state: Alabama
city: Phoenix
country: United States
facility: St. Josephs Hospital and Med Center /ID# 204197
state: Arizona
city: Berkeley
country: United States
facility: Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249
state: California
city: Carlsbad
country: United States
facility: The Research Center of Southern California /ID# 204269
state: California
city: Hanford
country: United States
facility: Vladimir Royter MD /ID# 204392
state: California
city: Irvine
country: United States
facility: UC Irvine Health /ID# 205728
state: California
city: Palo Alto
country: United States
facility: Stanford MS Center /ID# 204283
state: California
city: Sacramento
country: United States
facility: UC Davis Health-Neurological Surgery /ID# 204188
state: California
city: San Francisco
country: United States
facility: UCSF School of Medicine - Neurology /ID# 204251
state: California
city: Aurora
country: United States
facility: University of Colorado School of Medicine /ID# 204250
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, LLC /ID# 204289
state: Colorado
city: Chicago
country: United States
facility: The University of Chicago Medical Center /ID# 205319
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ School Medicine /ID# 204891
state: Indiana
city: Lenexa
country: United States
facility: Rowe Neurology Institute /ID# 204391
state: Kansas
city: Baton Rouge
country: United States
facility: The NeuroMedical Center /ID# 204253
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center /ID# 204189
state: Louisiana
city: Baltimore
country: United States
facility: Duplicate_Parexel International /ID# 204273
state: Maryland
city: Lutherville
country: United States
facility: International Neurorehabilitation Institute /ID# 213332
state: Maryland
city: Boston
country: United States
facility: Pediatric Endocrine Associates /ID# 204279
state: Massachusetts
city: Farmington Hills
country: United States
facility: Michigan Institute for Neurological Disorders (MIND) /ID# 204194
state: Michigan
city: Owosso
country: United States
facility: Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206328
state: Michigan
city: Chaska
country: United States
facility: Ridgeview Specialty Clinic Chaska - Neurology /ID# 204383
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 204388
state: Missouri
city: Saint Louis
country: United States
facility: The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205433
state: Missouri
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Cent /ID# 204745
state: Nevada
city: Oklahoma City
country: United States
facility: Oklahoma Med Res. Foundation /ID# 204389
state: Oklahoma
city: Portland
country: United States
facility: Providence Neurological Specialties - West /ID# 204248
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University /ID# 204281
state: Pennsylvania
city: Franklin
country: United States
facility: Advanced Neurosciences Institute /ID# 204557
state: Tennessee
city: Franklin
country: United States
facility: KCA Neurology - Franklin /ID# 204208
state: Tennessee
city: Johnson City
country: United States
facility: Tri-State Mountain Neurology /ID# 204252
state: Tennessee
city: Dallas
country: United States
facility: Neurology Consultants of Dallas - LBJ Fwy /ID# 204398
state: Texas
city: Houston
country: United States
facility: UT HSC Multiple Sclerosis Research Group - Houston /ID# 206418
state: Texas
city: Lubbock
country: United States
facility: Dr. Bhupesh Dihenia, MD, PA /ID# 207839
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology Consul /ID# 204268
state: Texas
city: Alexandria
country: United States
facility: Integrated Neurology Services, PLLC /ID# 204261
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Neuroscience Institute /ID# 204203
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center /ID# 205440
state: Washington
city: Seattle
country: United States
facility: Swedish MS Center /ID# 204198
state: Washington
city: Seattle
country: United States
facility: University of Washington Medicine MS Center /ID# 205852
state: Washington
city: Morgantown
country: United States
facility: West Virginia Univ School Med /ID# 204292
state: West Virginia
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital /ID# 204202
state: Wisconsin
city: Vancouver
country: Canada
facility: University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 204841
state: British Columbia
city: London
country: Canada
facility: Duplicate_London Health Sciences Centre - University Hospital /ID# 204848
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 204842
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto - St. Michael's Hospital /ID# 206214
state: Ontario
city: Greenfield Park
country: Canada
facility: Recherche Sepmus Inc. /ID# 212851
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 204844
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Institut /ID# 204843
state: Quebec
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: