Elezanumab for Spinal Cord Injury

(ELASCI Trial)

Not currently recruiting at 58 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests elezanumab, a new drug that might aid nerve recovery after a spinal cord injury. The goal is to determine its safety and effectiveness in improving arm and hand movement in individuals with a sudden neck injury affecting the spinal cord. Those who have experienced an acute neck spinal cord injury within the last 24 hours and can begin treatment quickly may be suitable candidates. Participants will receive either elezanumab or a placebo (a harmless substance with no effect) and will undergo regular check-ups to monitor progress. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that elezanumab, a treatment in development for spinal cord injuries, has generally been well-tolerated in past studies. Elezanumab blocks a protein that inhibits nerve growth, potentially aiding nerve healing after injury.

Earlier research found that elezanumab helped recovery after spinal cord injuries. These studies reported no major safety issues. Some participants, particularly in certain groups, had higher drug levels, but this did not lead to serious side effects.

This treatment remains under study. While early results are promising, further research is necessary to fully understand its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for spinal cord injury?

Researchers are excited about elezanumab because it offers a novel approach to treating spinal cord injuries. Unlike current treatments that focus on managing symptoms or reducing inflammation, elezanumab is an antibody that targets a protein called repulsive guidance molecule A (RGMa). By inhibiting RGMa, elezanumab aims to promote nerve regeneration and functional recovery, which could significantly improve outcomes for patients. This mechanism of action represents a promising shift from traditional therapies, potentially opening new avenues for healing and mobility restoration.

What evidence suggests that elezanumab might be an effective treatment for spinal cord injury?

Research has shown that elezanumab, a type of protein, might aid people with spinal cord injuries by supporting nerve healing. In studies with rats, elezanumab improved movement and fine motor skills when administered soon after injury. It also helped them regain bladder control more quickly. These findings suggest that elezanumab, which participants in this trial may receive, could enhance human recovery after spinal cord injuries by blocking inhibitors of nerve growth. Although these results are preliminary, the data is promising for treating spinal cord injuries. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12392050/

Randomized, Double‐Blind, Placebo‐Controlled, Multiple ... Delayed administration of the human anti‐RGMa monoclonal antibody elezanumab promotes functional recovery including spontaneous voiding after spinal cord injury ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04295538

NCT04295538 | Safety And Efficacy Study Of Intravenous ... Acute Spinal Cord Injury (SCI) is a rare injury that leads to permanent neuromotor impairment and sudden disability. Approximately 25,000 people experience ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32590037/

Delayed administration of the human anti-RGMa ... Rats treated with elezanumab acutely and at 3 h post-injury showed improvements in overground locomotion and fine motor function and gait.

4. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M16-077

M16-077 Elezanumab to assess change in upper extremity motor score (UEMS) in adult participants with acute traumatic cervical spinal cord injury (SCI).

5. sciencedirect.com sciencedirect.com/science/article/pii/S0969996122002042

Delayed administration of elezanumab, a human anti- ... Delayed treatment with elezanumab promotes earlier recovery of spontaneous voiding after cervical spinal cord injury. A) As shown in the ...

6. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/cpdd.1341

Comparability of Elezanumab Safety, Tolerability, and ... Elezanumab exposures were approximately 20% higher in Japanese and Han Chinese participants compared to White participants without controlling for body weight.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0969996121001340

Elezanumab, a human anti-RGMa monoclonal antibody, ... Elezanumab, a human anti-RGMa monoclonal antibody, promotes neuroprotection, neuroplasticity, and neurorecovery following a thoracic hemicompression spinal cord ...