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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Spinal Cord Injury (SCI)

In brief

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.

Key facts

Study ID: NCT04295538
Run by: AbbVie
People needed: 60
Starts: 2020-09-06
Expected to finish: 2026-01-26
Last updated by the study team: 2026-02-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Acute traumatic cervical spinal cord injury (SCI), neurological level of injury of C4, C5, C6, or C7 with no damage to cord in thoracic (T2 and beyond) and lumbar regions that, in the investigator's opinion, would significantly limit recovery.
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.

You may not qualify if…

Evidence of complete spinal cord transection.
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.

Where it is running

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
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
Duplicate_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
QEII - Health Sciences Centre /ID# 215249 — Halifax, Nova Scotia, Canada

Full record on ClinicalTrials.gov

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