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Monoclonal Antibodies

Elezanumab for Spinal Cord Injury (ELASCI Trial)

Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute traumatic cervical spinal cord injury (SCI) with 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
American Spinal Injury Association Impairment Scale (AIS) grade A or B at Screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

ELASCI Trial 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.Check my eligibility
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.See study design
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.

ELASCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a spinal cord injury at the neck level without damage to my mid or lower back.
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My spinal injury is classified as complete or sensory incomplete.
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I can start the study medication within a day of my injury.

ELASCI Trial 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

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

ELASCI 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
950 Previous Clinical Trials
496,874 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
390 Previous Clinical Trials
141,665 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the precedence for this kind of drug testing?

"AbbVie first sponsored a clinical trial for Elezanumab in 2020. This initial study, which involved 54 participants, was immediately followed by Phase 2 drug approval. Now, there are 58 cities and 7 countries with active studies underway."

Answered by AI

Are there any historical data points we can refer to with Elezanumab?

"The antibody drug elezanumab was first studied in 2020 at CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 215210. So far, there have been 18294 completed clinical trials. Right now, there are 2 ongoing studies with several of these trials based in Boston, Massachusetts."

Answered by AI

Could I be a test subject for this research?

"This study is looking for 54 participants that have recently sustained a spinal cord injury, are between 18-75 years old, meet the American Spinal Injury Association Impairment Scale criteria, and have damage limited to the cervical region of their spinal cord."

Answered by AI

What is the Elezanumab FDA approval process?

"While Phase 2 trials don't have data supporting efficacy, there is some information indicating that Elezanumab may be safe. Our analysts gave it a score of 2."

Answered by AI

Is this clinical trial taking place in more than one hospital within the state?

"This study is currently enrolling patients at 29 locations. Some notable enrolment sites include Hopital du Sacre Coeur Montreal /ID# 215210 in Boston, Brigham and Women's Hospital /ID# 216342 in Sacramento, and UC Davis Health-Neurological Surgery /ID# 224892 in Portland."

Answered by AI

How many people are signing up for this clinical trial?

"In order to move forward with this study, we need 54 individuals that meet the pre-specified eligibility requirements. Those interested can participate at Hopital du Sacre Coeur Montreal /ID# 215210 in Boston, Massachusetts or Brigham and Women's Hospital /ID# 216342 in Sacramento, California."

Answered by AI

Is this clinical trial intended for a specific age demographic?

"Enrolment for this study is only possible for those aged 18-75. There are a total of 144 trials involving minors and 770 studies with elderly patients."

Answered by AI

Can new participants join this research project at this time?

"Indeed, the latest information available on clinicaltrials.gov reveals that this trial is still searching for participants. The original posting date was September 6th 2020 and the page was updated as recently as August 2nd 2022."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Shepherd Center, Inc /ID# 230370
Duke Cancer Center /ID# 216888
What portion of applicants met pre-screening criteria?
Did not meet criteria
~14 spots leftby Jul 2025