A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
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
1 other identifier
interventional
208
2 countries
49
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with relapsing Multiple Sclerosis (RMS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2018
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2018
CompletedFirst Posted
Study publicly available on registry
November 13, 2018
CompletedStudy Start
First participant enrolled
December 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2021
CompletedResults Posted
Study results publicly available
December 22, 2023
CompletedDecember 22, 2023
December 1, 2023
2.7 years
November 6, 2018
November 14, 2023
December 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Overall Response Score (ORS) at 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.
Week 52
Secondary Outcomes (4)
Disability Improvement Response Rate
Week 52
Overall Response Score (ORS)
Week 12
Overall Response Score (ORS)
Week 24
Overall Response Score (ORS)
Week 36
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants randomized to receive double-blind placebo by intravenous infusion.
Elezanumab Dose 1
EXPERIMENTALParticipants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
Elezanumab Dose 2
EXPERIMENTALParticipants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- Participants must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (49)
University of Alabama at Birmingham - Main /ID# 204618
Birmingham, Alabama, 35233, United States
St. Josephs Hospital and Med Center /ID# 204197
Phoenix, Arizona, 85013, United States
Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249
Berkeley, California, 94705-2017, United States
The Research Center of Southern California /ID# 204269
Carlsbad, California, 92011-4213, United States
Vladimir Royter MD /ID# 204392
Hanford, California, 93230-5787, United States
UC Irvine Health /ID# 205728
Irvine, California, 92697, United States
Stanford MS Center /ID# 204283
Palo Alto, California, 94304-1416, United States
UC Davis Health-Neurological Surgery /ID# 204188
Sacramento, California, 95817-2307, United States
UCSF School of Medicine - Neurology /ID# 204251
San Francisco, California, 94143-0003, United States
University of Colorado School of Medicine /ID# 204250
Aurora, Colorado, 80045-2527, United States
Advanced Neurosciences Research, LLC /ID# 204289
Fort Collins, Colorado, 80528, United States
The University of Chicago Medical Center /ID# 205319
Chicago, Illinois, 60637-1443, United States
Indiana Univ School Medicine /ID# 204891
Indianapolis, Indiana, 46202, United States
Rowe Neurology Institute /ID# 204391
Lenexa, Kansas, 66214, United States
The NeuroMedical Center /ID# 204253
Baton Rouge, Louisiana, 70810, United States
Ochsner Medical Center /ID# 204189
New Orleans, Louisiana, 70121-2429, United States
Duplicate_Parexel International /ID# 204273
Baltimore, Maryland, 21225, United States
International Neurorehabilitation Institute /ID# 213332
Lutherville, Maryland, 21093-6016, United States
Pediatric Endocrine Associates /ID# 204279
Boston, Massachusetts, 02114, United States
Michigan Institute for Neurological Disorders (MIND) /ID# 204194
Farmington Hills, Michigan, 48334, United States
Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206328
Owosso, Michigan, 48867-2116, United States
Ridgeview Specialty Clinic Chaska - Neurology /ID# 204383
Chaska, Minnesota, 55318-4551, United States
Washington University-School of Medicine /ID# 204388
St Louis, Missouri, 63110, United States
The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205433
St Louis, Missouri, 63131-2322, United States
Cleveland Clinic Lou Ruvo Cent /ID# 204745
Las Vegas, Nevada, 89106-0100, United States
Oklahoma Med Res. Foundation /ID# 204389
Oklahoma City, Oklahoma, 73104, United States
Providence Neurological Specialties - West /ID# 204248
Portland, Oregon, 97225-6646, United States
Thomas Jefferson University /ID# 204281
Philadelphia, Pennsylvania, 19107, United States
Advanced Neurosciences Institute /ID# 204557
Franklin, Tennessee, 37064, United States
KCA Neurology - Franklin /ID# 204208
Franklin, Tennessee, 37067-5914, United States
Tri-State Mountain Neurology /ID# 204252
Johnson City, Tennessee, 37604, United States
Neurology Consultants of Dallas - LBJ Fwy /ID# 204398
Dallas, Texas, 75243-1188, United States
UT HSC Multiple Sclerosis Research Group - Houston /ID# 206418
Houston, Texas, 77030-1501, United States
Dr. Bhupesh Dihenia, MD, PA /ID# 207839
Lubbock, Texas, 79410, United States
Central Texas Neurology Consul /ID# 204268
Round Rock, Texas, 78681, United States
Integrated Neurology Services, PLLC /ID# 204261
Alexandria, Virginia, 22310, United States
Evergreen Neuroscience Institute /ID# 204203
Kirkland, Washington, 98034-3029, United States
Virginia Mason Medical Center /ID# 205440
Seattle, Washington, 98101, United States
Swedish MS Center /ID# 204198
Seattle, Washington, 98122-5698, United States
University of Washington Medicine MS Center /ID# 205852
Seattle, Washington, 98133-8400, United States
West Virginia Univ School Med /ID# 204292
Morgantown, West Virginia, 26506, United States
Froedtert Memorial Lutheran Hospital /ID# 204202
Milwaukee, Wisconsin, 53226-3522, United States
University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 204841
Vancouver, British Columbia, V6T 1Z3, Canada
Duplicate_London Health Sciences Centre - University Hospital /ID# 204848
London, Ontario, N6A 5A5, Canada
Ottawa Hospital Research Institute /ID# 204842
Ottawa, Ontario, K1H 8L6, Canada
Unity Health Toronto - St. Michael's Hospital /ID# 206214
Toronto, Ontario, M5B 1W8, Canada
Recherche Sepmus Inc. /ID# 212851
Greenfield Park, Quebec, J4V 2J2, Canada
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 204844
Montreal, Quebec, H2X 0A9, Canada
Montreal Neurological Institut /ID# 204843
Montreal, Quebec, H3A 2B4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2018
First Posted
November 13, 2018
Study Start
December 11, 2018
Primary Completion
August 9, 2021
Study Completion
September 9, 2021
Last Updated
December 22, 2023
Results First Posted
December 22, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.