Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury

Phase 1

• Conditions: Spinal cord injury (SCI); MedDRA version: 20.1Level: PTClassification code 10041552Term: Spinal cord injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-003752-36-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-15
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

- Subjects or their legally authorized representative must voluntarily provide informed consent prior to 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 70 years of age, inclusive.
- Acute traumatic cervical SCI, motor 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 (2019 criteria) at Screening.
- Able to initiate study drug administration within 24 hours of injury.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- No absence of complete spinal cord transection, as demonstrated by MRI evidence of cord continuity at site of lesion confirmed by neuroradiologist.
- 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 have 1 or more upper extremity muscle groups untestable (e.g., immobilized or restricted by a cast) during the screening ISNCSCI examination.
- Known history prior to randomization of clinically significant medical or surgical conditions (other than current acute SCI) or any other reason, including any physical, psychological, or psychiatric condition that in the opinion of the Investigator would compromise the safety or interfere with the subject's participation in this study, or would make the subject an unsuitable candidate to receive study drug, or would put the subject at risk by participating in the study, including history of or abnormal screening lab or imaging results that, in the opinion of the investigator, are indicative of any irreparable cardiac, endocrinologic, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic, and/or other major disease that would preclude administration of elezanumab.
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: UEMS scores between treatment and placebo.;Main Objective: To assess the safety and efficacy of elezanumab in subjects with acute traumatic cervical SCI.;Secondary Objective: NA;Primary end point(s): The primary endpoint is the Upper Extremity Motor Score (UEMS), a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI, 2019 criteria) during the Treatment Period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints are: <br>- Spinal Cord Independence Measures (SCIM III) self-care score, <br>- UEMS change from Baseline;Timepoint(s) of evaluation of this end point: - SCIM-III is over the duration of the study<br>- UEMS change from baseline at week 52