Elezanumab for Spinal Cord Injury (ELASCI Trial)

Recruiting in Palo Alto (17 mi)

+50 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AbbVie

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-75 with recent traumatic cervical spinal cord injuries at specific levels (C4-C7) without further damage to the thoracic or lumbar regions. Participants must have a certain severity of injury (AIS grade A or B) and be able to start treatment within 24 hours of injury. Pregnant women, those with complete spinal transection, significant head injuries, or who've recently been in other studies are excluded.

Inclusion Criteria

My spinal injury is classified as complete or sensory incomplete.

Exclusion Criteria

I am not pregnant, breastfeeding, nor planning to become pregnant soon.

I have a serious head injury with notable changes on a CT scan.

My spinal cord injury was caused by a gunshot, stabbing, seizure, or an attempted suicide.

I cannot use one or more of my arm muscles during a specific nerve test.

Participant Groups

The study tests if elezanumab, an investigational drug that may promote nerve regeneration, is safe and improves arm function in acute cervical SCI patients compared to placebo. It's double-blinded and participants are randomly assigned to receive either elezanumab or placebo via IV within 24 hours post-injury and every four weeks up to Week 48.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ElezanumabExperimental Treatment1 Intervention

Participants will receive elezanumab dose A

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo for elezanumab