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A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury
Acute Spinal Cord Injury (SCI) is a rare injury that leads to permanent neuromotor impairment and sudden disability. Approximately 25,000 people experience cervical SCI in the United States, Europe, and Japan every year. The purpose of this study is to see if elezanumab is safe and assess change in Upper Extremity Motor Score (UEMS) in participants with acute traumatic cervical SCI. Elezanumab is an investigational drug being developed for the treatment of SCI. Elezanumab is a monoclonal antibody, that binds to an inhibitor of neuronal regeneration and neutralizes the inhibitor, thus potentially promoting neuroregeneration. This study is "double-blinded", which means that neither trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Participants 18-75 years of age with a SCI will be enrolled. Approximately 54 participants will be enrolled in the study in approximately 49 sites worldwide. Participants will receive intravenous (IV) doses of elezanumab or placebo within 24 hours of injury and every 4 weeks thereafter through Week 48 for a total of 13 doses. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
University of California Davis Health /ID# 224892
Sacramento, California, United States
Shepherd Center, Inc /ID# 230370
Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine /ID# 218009
Chicago, Illinois, United States
University of Louisville Hospital /ID# 215948
Louisville, Kentucky, United States
Duplicate_Tufts Medical Center /ID# 225410
Boston, Massachusetts, United States
Brigham & Women's Hospital /ID# 216342
Boston, Massachusetts, United States
Duplicate_Boston University School of Medicine /ID# 218371
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 218149
Boston, Massachusetts, United States
Regents of the University of Michigan /ID# 215890
Ann Arbor, Michigan, United States
Washington University-School of Medicine /ID# 215325
St Louis, Missouri, United States
Start Date
September 6, 2020
Primary Completion Date
January 26, 2026
Completion Date
January 26, 2026
Last Updated
February 11, 2026
60
ACTUAL participants
Elezanumab
DRUG
Placebo
DRUG
Lead Sponsor
AbbVie
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02052024