Elezanumab for Stroke

(EAISE Trial)

No longer recruiting at 68 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Severe stroke, Acute seizure, Myocardial infarction, Complex migraine, others

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

Compensation: Varies

Number of Visits: 13

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests elezanumab, an experimental drug, to determine if it can aid recovery after an acute ischemic stroke, which occurs when a blood vessel in the brain becomes blocked. Participants will receive either elezanumab or a placebo (a non-active substance) without knowing which one, to ensure a fair assessment of the drug's effects. The study will monitor changes in neurologic function and any side effects over a year. Individuals who have experienced an acute ischemic stroke and can begin the trial within 24 hours of their last normal state may be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the study team to get a clear answer.

Is there any evidence suggesting that elezanumab is likely to be safe for humans?

Research has shown that elezanumab, an experimental drug for stroke recovery, was safe in earlier studies. Specifically, studies with healthy volunteers found that elezanumab was generally safe and well-tolerated, with most people not experiencing serious side effects. While some mild side effects can occur, they are usually not severe.

Since this is a Phase 2 trial, elezanumab has already passed initial safety tests. This phase focuses more on understanding its effectiveness and continues to monitor for any side effects. However, as the drug is still under investigation, unknown risks may exist.

Overall, current evidence suggests that elezanumab is safe to try in a controlled setting like a clinical trial. Participants will receive close monitoring throughout the trial to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard stroke treatments that focus on restoring blood flow or preventing further clots, Elezanumab works differently by targeting a specific protein in the nervous system called RGMa. This protein can inhibit nerve regeneration after a stroke, and by blocking it, Elezanumab may encourage the repair of nerve connections. Researchers are excited because this approach has the potential to promote actual recovery of brain function, rather than just managing symptoms.

What evidence suggests that elezanumab might be an effective treatment for stroke?

Research has shown that elezanumab, which participants in this trial may receive, might aid recovery after a stroke. In earlier studies, patients who received elezanumab demonstrated better movement and muscle control compared to those who did not. This treatment blocks a molecule called RGMa, which can hinder nerve healing after a stroke. Early results suggest that this could lead to quicker and more complete recovery from stroke-related disabilities. ^{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 who've had a recent acute ischemic stroke, can start treatment within 24 hours of their last normal health status, and have a moderate level of stroke severity. It's not for those with severe strokes on imaging, heart attack symptoms, significant other medical conditions, or women who are pregnant/breastfeeding.

Inclusion Criteria

I have been diagnosed with a stroke, confirmed by a brain scan.

Participants or their legally authorized representative confirms that prior to index stroke, no significant impairment in participant's ability to perform activities of daily living without assistance

Able to randomize within 24 hours of last known normal

Exclusion Criteria

Known history prior to randomization of clinically significant medical conditions (other than current acute ischemic stroke) or any other reason, including any physical, psychological, or psychiatric condition that in the investigator's opinion would compromise the safety or interfere with the participant's participation in this study

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

My symptoms are expected to improve within a few hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive elezanumab or placebo by intravenous infusion every 4 weeks for 48 weeks

48 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Elezanumab

Trial Overview The study tests Elezanumab against a placebo in patients following an acute ischemic stroke. Participants won't know which they're receiving. They'll get the drug/placebo via IV within 24 hours after symptoms start and every four weeks for nearly a year.

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

Published Research Related to This Trial

Elezanumab, a monoclonal antibody targeting RGMa, was found to be safe and well-tolerated in a study involving 47 healthy participants and 20 individuals with multiple sclerosis, with no significant adverse events reported.

The drug demonstrated effective central nervous system penetration and reduced levels of free RGMa in cerebrospinal fluid, indicating its potential to modulate inflammatory pathways in multiple sclerosis, particularly at higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 Evaluation of Elezanumab (Anti-Repulsive Guidance Molecule A Monoclonal Antibody) in Healthy and Multiple Sclerosis Participants. Kalluri, HV., Rosebraugh, MR., Misko, TP., et al.[2023]

Citations

1. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M19-148

M19-148 A safety and efficacy study of intravenous (IV) elezanumab assessing change in neurologic function in adult participants with acute ischemic stroke.

2. ahajournals.org ahajournals.org/doi/10.1161/str.53.suppl_1.TP7

Abstract TP7: Phase 2a Study Of Elezanumab In Patients ... This phase 2 study will evaluate safety and efficacy of elezanumab, a novel therapeutic intervention to improve neurological recovery after acute ischemic ...

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

Randomized, Double‐Blind, Placebo‐Controlled, Multiple ... Inclusion of these outcomes enabled investigation of elezanumab's potential neurorestorative effects from multiple angles to assess consistency of a possible ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11226526/

Neutralizing RGMa with Elezanumab Promotes ... In this preclinical study, we evaluated whether elezanumab, a human anti-RGMa monoclonal antibody, could improve neuromotor function and modulate ...

5. neurologylive.com neurologylive.com/view/increased-levels-neurofilament-light-gfap-confirmed-during-acute-stroke

Increased Levels of Neurofilament Light and GFAP ... Results showed that all doses of elezanumab demonstrated statistically significantly improved neuromotor function and recovery rate versus ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20505706

Clinical Trials The purpose of this study is to assess the effectiveness, safety, tolerability, and pharmacokinetics (PK) of elezanumab in subjects with acute ischemic stroke ...

7. sigma.larvol.com sigma.larvol.com/product.php?e1=580108&tab=newstrac

elezanumab (ABT-555) News Elezanumab was safe and well tolerated, but did not meet the primary endpoint in either study. ANN NEUROL 2025;98:590-602. |||||||||| elezanumab ( ...