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Monoclonal Antibodies

Elezanumab for Spinal Cord Injury (ELASCI Trial)

Phase 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
American Spinal Injury Association Impairment Scale (AIS) grade A or B at Screening.
Be older than 18 years old
Must not have
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
Significant concomitant head injury with a clinically significant abnormality on a head computed tomography (CT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks

Summary

This trial is being done to find out if elezanumab is safe and to see if it improves motor function in people with acute cervical SCI.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects aren't listed but as a monoclonal antibody therapy targeting nerve regeneration inhibitors, potential side effects could include allergic reactions, immune system changes leading to increased infection risk, inflammation around injection sites among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My spinal injury is classified as complete or sensory incomplete.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, nor planning to become pregnant soon.
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I have a serious head injury with notable changes on a CT scan.
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My spinal cord injury was caused by a gunshot, stabbing, seizure, or an attempted suicide.
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I cannot use one or more of my arm muscles during a specific nerve test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Upper Extremity Motor Score (UEMS)
Secondary study objectives
Change from Baseline in Spinal Cord Independence Measures (SCIM III) Self-Care Score
Change in Upper Extremity Motor Score (UEMS) From Baseline

Trial Design

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

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,023 Previous Clinical Trials
520,254 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
444 Previous Clinical Trials
160,740 Total Patients Enrolled

Media Library

Elezanumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04295538 — Phase 2
Spinal Cord Injury Research Study Groups: Placebo, Elezanumab
Spinal Cord Injury Clinical Trial 2023: Elezanumab Highlights & Side Effects. Trial Name: NCT04295538 — Phase 2
Elezanumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04295538 — Phase 2
~5 spots leftby May 2025
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