Elezanumab for Stroke

(EAISE Trial)

Recruiting at 56 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

121 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called elezanumab to help people recover from a stroke. The study includes people who have had a stroke caused by a blocked blood vessel. Elezanumab is given through an IV and aims to help the brain heal better. The trial will check if the drug is safe and effective.

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.

How does the drug Elezanumab differ from other treatments for stroke?

Elezanumab is unique because it targets repulsive guidance molecule A (RGMa), which is involved in inhibiting nerve growth and survival after a stroke. Unlike current treatments that have a narrow time window, Elezanumab has a longer time window for administration, potentially allowing more patients to benefit from its neuroprotective effects. ^{1 2 3 4 5}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

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

My symptoms are expected to improve within a few hours.

Timeline

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

Treatment Details

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.

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

Findings from Research

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]

References

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

Immune Responses and Anti-inflammatory Strategies in a Clinically Relevant Model of Thromboembolic Ischemic Stroke with Reperfusion. [2021]

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

Current status of antiplatelet agents to prevent stroke. [2021]

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

Neutralizing RGMa with Elezanumab Promotes Cerebroprotection and Recovery in Rabbit Middle Cerebral Artery Occlusion. [2023]

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

Phase 1 Evaluation of Elezanumab (Anti-Repulsive Guidance Molecule A Monoclonal Antibody) in Healthy and Multiple Sclerosis Participants. [2023]

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

Safety and efficacy of natalizumab in patients with acute ischaemic stroke (ACTION): a randomised, placebo-controlled, double-blind phase 2 trial. [2022]