A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive 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 Progressive Forms of Multiple Sclerosis
1 other identifier
interventional
123
2 countries
37
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2019
37 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
February 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2021
CompletedResults Posted
Study results publicly available
December 21, 2023
CompletedDecember 21, 2023
December 1, 2023
1.9 years
November 6, 2018
November 14, 2023
December 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Overall Response Score (ORS)
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 placebo by intravenous infusion.
Elezanumab 400mg Dose
EXPERIMENTALParticipants randomized to receive 400mg of elezanumab by intravenous infusion.
Elezanumab 1800 mg Dose
EXPERIMENTALParticipants randomized to receive 1800mg of elezanumab by intravenous infusion.
Interventions
solution for infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (37)
St. Josephs Hospital and Med Center /ID# 202809
Phoenix, Arizona, 85013, United States
Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 202448
Berkeley, California, 94705-2017, United States
The Research Center of Southern California /ID# 202802
Carlsbad, California, 92011-4213, United States
Vladimir Royter MD /ID# 202483
Hanford, California, 93230-5787, United States
Stanford MS Center /ID# 202445
Palo Alto, California, 94304-1416, United States
UC Davis Health-Neurological Surgery /ID# 202485
Sacramento, California, 95817-2307, United States
UCSF School of Medicine - Neurology /ID# 203194
San Francisco, California, 94143-0003, United States
University of Colorado School of Medicine, Dept of Neurology /ID# 202807
Aurora, Colorado, 80045-2527, United States
Advanced Neurosciences Research, LLC /ID# 203072
Fort Collins, Colorado, 80528, United States
Rowe Neurology Institute /ID# 202744
Lenexa, Kansas, 66214, United States
Duplicate_Parexel International /ID# 202747
Baltimore, Maryland, 21225, United States
International Neurorehabilitation Institute /ID# 213333
Lutherville, Maryland, 21093-6016, United States
Michigan Institute for Neurological Disorders (MIND) /ID# 202470
Farmington Hills, Michigan, 48334, United States
Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206327
Owosso, Michigan, 48867-2116, United States
Ridgeview Specialty Clinic Chaska - Neurology /ID# 204384
Chaska, Minnesota, 55318-4551, United States
Washington University-School of Medicine /ID# 202899
St Louis, Missouri, 63110, United States
The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205432
St Louis, Missouri, 63131-2322, United States
Cleveland Clinic Lou Ruvo Cent /ID# 204744
Las Vegas, Nevada, 89106-0100, United States
Oklahoma Med Res. Foundation /ID# 203442
Oklahoma City, Oklahoma, 73104, United States
Providence Neurological Specialties - West /ID# 203193
Portland, Oregon, 97225-6646, United States
Advanced Neurosciences Institute /ID# 204555
Franklin, Tennessee, 37064, United States
KCA Neurology - Franklin /ID# 202912
Franklin, Tennessee, 37067-5914, United States
Neurology Consultants of Dallas - LBJ Fwy /ID# 203102
Dallas, Texas, 75243-1188, United States
Central Texas Neurology Consul /ID# 203108
Round Rock, Texas, 78681, United States
Integrated Neurology Services /ID# 202743
Alexandria, Virginia, 22310, United States
Evergreen Neuroscience Institute /ID# 204205
Kirkland, Washington, 98034-3029, United States
Virginia Mason Medical Center /ID# 205439
Seattle, Washington, 98101, United States
Swedish MS Center /ID# 202904
Seattle, Washington, 98122-5698, United States
West Virginia Univ School Med /ID# 202849
Morgantown, West Virginia, 26506, United States
Froedtert Memorial Lutheran Hospital /ID# 202618
Milwaukee, Wisconsin, 53226-3522, United States
University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 203536
Vancouver, British Columbia, V6T 1Z3, Canada
Duplicate_London Health Sciences Centre - University Hospital /ID# 203538
London, Ontario, N6A 5A5, Canada
Ottawa Hospital Research Institute /ID# 203058
Ottawa, Ontario, K1H 8L6, Canada
Unity Health Toronto - St. Michael's Hospital /ID# 206213
Toronto, Ontario, M5B 1W8, Canada
Recherche Sepmus Inc. /ID# 212852
Greenfield Park, Quebec, J4V 2J2, Canada
Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 203869
Montreal, Quebec, H2X 0A9, Canada
Montreal Neurological Institut /ID# 203868
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
February 27, 2019
Primary Completion
January 15, 2021
Study Completion
August 30, 2021
Last Updated
December 21, 2023
Results First Posted
December 21, 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.