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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) (ELASCI)
EU CTIS ID: 2023-505125-14-00
What this study is testing
To assess the safety and efficacy of elezanumab in subjects with acute traumatic cervical SCI.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects or their legally authorized representative must voluntarily provide informed consent before the initiation of any study-specific procedure in a form approved by an independent ethics committee (IEC)/institutional review board (IRB). In the absence of subject's ability to provide informed consent, informed consent must be given by a person who has the legal right to act on behalf of the subject in accordance with local laws.
- Adult male or female, between 18 and 75 years of age, inclusive.
- Acute traumatic cervical SCI, neurological level of injury of C4, C5, C6, or C7 (cervical lesion as defined by first ISNCSCI) 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.
- AIS grade A or B at Screening.
- Able to initiate study drug administration within 24 hours of injury.
You likely can't join if
- Significant concomitant head injury with a clinically significant abnormality on a head computed tomography (CT). CT required only for subjects suspected to have a brain injury at the discretion of the investigator.
- Must not have 1 or more upper extremity muscle groups untestable (e.g., immobilized or restricted by a cast) during the screening ISNCSCI examination.
- No 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.
See the full eligibility criteria
- Subjects or their legally authorized representative must voluntarily provide informed consent before the initiation of any study-specific procedure in a form approved by an independent ethics committee (IEC)/institutional review board (IRB). In the absence of subject's ability to provide informed consent, informed consent must be given by a person who has the legal right to act on behalf of the subject in accordance with local laws.
- Adult male or female, between 18 and 75 years of age, inclusive.
- Acute traumatic cervical SCI, neurological level of injury of C4, C5, C6, or C7 (cervical lesion as defined by first ISNCSCI) 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.
- AIS grade A or B at Screening.
- Able to initiate study drug administration within 24 hours of injury.
- Subjects 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.
- Significant concomitant head injury with a clinically significant abnormality on a head computed tomography (CT). CT required only for subjects suspected to have a brain injury at the discretion of the investigator.
- Must not have 1 or more upper extremity muscle groups untestable (e.g., immobilized or restricted by a cast) during the screening ISNCSCI examination.
- No 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 study team makes the final eligibility decision.
Where it's taking place
- Israel
- Korea, Republic of
- Japan
- Australia
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Korea, Republic of; Japan; Australia; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.