Safety And Efficacy Study Of Intravenous (IV) Administration Of Elezanumab To Assess Change In Upper Extremity Motor Score (UEMS) In Adult Participants With Acute Traumatic Cervical Spinal Cord Injury (SCI)
NCT ID: NCT04295538
Last Updated: 2025-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2020-09-06
2026-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Elezanumab
Participants will receive elezanumab dose A
Elezanumab
Solution for infusion; Intravenous (IV)
Placebo
Participants will receive placebo for elezanumab
Placebo
Solution for infusion; Intravenous (IV)
Interventions
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Elezanumab
Solution for infusion; Intravenous (IV)
Placebo
Solution for infusion; Intravenous (IV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Maximum screening UEMS of 32.
* American Spinal Injury Association Impairment Scale (AIS) grade A or B at Screening.
* Able to initiate study drug administration within 24 hours of injury.
* Participants with comorbid conditions that, in the investigator's opinion, are clinically stable and not expected to meaningfully progress in the following 12 months, may be considered eligible to participate.
Exclusion Criteria
* Significant concomitant head injury with a clinically significant abnormality on a head computed tomography (CT).
* One or more upper extremity muscle groups untestable (e.g., immobilized or restricted by a cast) during the screening International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination.
* Known receipt of any other investigational product within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study.
* Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or for within 39 weeks (5 half-lives) after the last dose of study drug.
* The cause of the acute SCI is one of the following: from gunshot or penetrating/stab wound; non-traumatic SCI, results of seizure, or known attempted suicide.
18 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
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
Hackensack Univ Med Ctr /ID# 215754
Hackensack, New Jersey, United States
Jersey Shore University Medical Center /ID# 218162
Neptune City, New Jersey, United States
Rutgers New Jersey School of Medicine /ID# 216212
Newark, New Jersey, United States
Duke Cancer Center /ID# 216888
Durham, North Carolina, United States
Oregon Medical Research Center /ID# 227371
Portland, Oregon, United States
University of Pennsylvania /ID# 218662
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital /ID# 215460
Philadelphia, Pennsylvania, United States
University of Virginia Health /ID# 218117
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital /ID# 218302
Norfolk, Virginia, United States
Virginia Commonwealth University Medical Center Main Hospital /ID# 217481
Richmond, Virginia, United States
West Virginia University Hospitals /ID# 217344
Morgantown, West Virginia, United States
Wisconsin Medical Center /ID# 215610
Milwaukee, Wisconsin, United States
Royal Adelaide Hospital /ID# 216953
Adelaide, South Australia, Australia
Foothills Medical Centre /ID# 214790
Calgary, Alberta, Canada
Duplicate_QEII - Health Sciences Centre /ID# 215249
Halifax, Nova Scotia, Canada
The Ottawa Hospital Civic Campus /ID# 215270
Ottawa, Ontario, Canada
Toronto Western Hospital /ID# 215214
Toronto, Ontario, Canada
CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 215210
Montreal, Quebec, Canada
The Chaim Sheba Medical Center /ID# 240917
Ramat Gan, Tel Aviv, Israel
NHO Nagoya Medical Center /ID# 239617
Nagoya, Aichi-ken, Japan
Funabashi Municipal Medical Center /ID# 225599
Funabashi-shi, Chiba, Japan
Japan Organization of Occupational Health and Safety Spinal Injuries Centre /ID# 224141
Iizuka-shi, Fukuoka, Japan
National Hospital Organization Murayama Medical Center /ID# 223492
Musashimurayama-shi, Tokyo, Japan
Ajou University Hospital /ID# 241119
Suwon, Gyeonggido, South Korea
Duplicate_Inha University Hospital /ID# 238890
Junggu, Incheon Gwang Yeogsi, South Korea
Complejo Hospitalario Universitario A Coruña /ID# 216384
A Coruña, A Coruna, Spain
Hospital Universitario Vall d'Hebron /ID# 217794
Barcelona, , Spain
Hospital Universitario 12 de Octubre /ID# 225354
Madrid, , Spain
Hospital Universitario Virgen del Rocio /ID# 225692
Seville, , Spain
Hospital Nacional de Paraplejicos /ID# 225508
Toledo, , Spain
Hospital Universitario y Politecnico La Fe /ID# 217797
Valencia, , Spain
Countries
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Other Identifiers
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2019-003752-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-077
Identifier Type: -
Identifier Source: org_study_id
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