Elezanumab for Spinal Cord Injury

(ELASCI Trial)

Recruiting at 50 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must not be taking: Investigational drugs

Disqualifiers: Complete transection, Head injury, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

60 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctors to understand how your current medications might interact with the trial requirements.

How does the drug Elezanumab differ from other treatments for spinal cord injury?

Elezanumab is unique because it is designed to target and inhibit a specific protein that may promote nerve growth and repair after spinal cord injury, unlike other treatments that primarily focus on reducing inflammation or pain. ^{1 2 3 4 5}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

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

You have severe impairment in your spinal cord function, as determined by a specific scale.

My spinal cord injury is in the neck area without damage to my mid or lower back.

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants 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

48 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Elezanumab
• Placebo

Trial Overview 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.

Participant Groups

Group I: Elezanumab Experimental Treatment 1 Intervention

Participants will receive elezanumab dose A

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo for elezanumab

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

References

1. England pubmed.ncbi.nlm.nih.gov

Tamoxifen attenuates inflammatory-mediated damage and improves functional outcome after spinal cord injury in rats. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Neuroprotective effects of raloxifene on experimental spinal cord injury in rats. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Pain in spinal cord injury. [2014]

4. Germany pubmed.ncbi.nlm.nih.gov

Etanercept treatment enhances clinical and neuroelectrophysiological recovery in partial spinal cord injury. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The expression of IL-1β can deteriorate the prognosis of nervous system after spinal cord injury. [2018]