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)

Phase 1

Conditions: Acute Traumatic Cervical Spinal Cord Injury
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: CTIS2023-505125-14-00

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion 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.

Exclusion Criteria

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.