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)
Public ClinicalTrials.gov record NCT04295538. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04295538
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 5, 2020
- Primary completion
- Jan 25, 2026
- Completion
- Jan 25, 2026
- Last update posted
- Feb 10, 2026
2020 – 2026
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Davis Health /ID# 224892 | Sacramento | California | 95817 | — |
| Shepherd Center, Inc /ID# 230370 | Atlanta | Georgia | 30309-1426 | — |
| Northwestern University Feinberg School of Medicine /ID# 218009 | Chicago | Illinois | 60611-2927 | — |
| University of Louisville Hospital /ID# 215948 | Louisville | Kentucky | 40202 | — |
| Duplicate_Tufts Medical Center /ID# 225410 | Boston | Massachusetts | 02111 | — |
| Brigham & Women's Hospital /ID# 216342 | Boston | Massachusetts | 02115 | — |
| Duplicate_Boston University School of Medicine /ID# 218371 | Boston | Massachusetts | 02118-2515 | — |
| Beth Israel Deaconess Medical Center /ID# 218149 | Boston | Massachusetts | 02215-5400 | — |
| Regents of the University of Michigan /ID# 215890 | Ann Arbor | Michigan | 48109-1276 | — |
| Washington University-School of Medicine /ID# 215325 | St Louis | Missouri | 63110 | — |
| Hackensack Univ Med Ctr /ID# 215754 | Hackensack | New Jersey | 07601 | — |
| Jersey Shore University Medical Center /ID# 218162 | Neptune City | New Jersey | 07753-4859 | — |
| Rutgers New Jersey School of Medicine /ID# 216212 | Newark | New Jersey | 07103 | — |
| Duplicate_Duke Cancer Center /ID# 216888 | Durham | North Carolina | 27710-3000 | — |
| Oregon Medical Research Center /ID# 227371 | Portland | Oregon | 97239 | — |
| University of Pennsylvania /ID# 218662 | Philadelphia | Pennsylvania | 19104-5502 | — |
| Thomas Jefferson University Hospital /ID# 215460 | Philadelphia | Pennsylvania | 19107 | — |
| University of Virginia Health /ID# 218117 | Charlottesville | Virginia | 22908 | — |
| Sentara Norfolk General Hospital /ID# 218302 | Norfolk | Virginia | 23507 | — |
| Virginia Commonwealth University Medical Center Main Hospital /ID# 217481 | Richmond | Virginia | 23219 | — |
| West Virginia University Hospitals /ID# 217344 | Morgantown | West Virginia | 26506 | — |
| Wisconsin Medical Center /ID# 215610 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04295538, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 10, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04295538 live on ClinicalTrials.gov.