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)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Spinal Cord Injury (SCI)

Intervention / Treatment
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* Drug: Elezanumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elezanumab<br>Participants will receive elezanumab dose A | Drug: Elezanumab<br>* Solution for infusion; Intravenous (IV)<br>* Other names: ABT-555;|
| Placebo Comparator: Placebo<br>Participants will receive placebo for elezanumab | Drug: Placebo<br>* Solution for infusion; Intravenous (IV)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Extremity Motor Score (UEMS) | The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that grades function of 5 key muscles in the upper limbs on a scale of 0 to 5 on each side from total paralysis to active full range of movement, respectively. | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Spinal Cord Independence Measures (SCIM III) Self-Care Score | The SCIM III self-care score addresses four areas of self-care management: feeding, grooming, bathing, and dressing. It has a total of 4 questions. Scores range from 0-20 where a score of 0 defines total dependence and 20 is indicative of complete independence. | Week 0 through Week 52 | 
| Change in Upper Extremity Motor Score (UEMS) From Baseline | The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that grades function of 5 key muscles in the upper limbs on a scale of 0 to 5 on each side from total paralysis to active full range of movement, respectively. | Week 0 through Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury (SCI), Cervical Spinal Cord Injury, Cervical SCI, Elezanumab, ABT-555, Upper Extremity Motor Score (UEMS), Acute Traumatic Cervical Spinal Cord Injury