A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke

A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke

Stroke is one of the leading causes death and major functional disability worldwide. Treatment options for acute stroke are limited with many patients having residual neurologic impairment. The purpose of this study is to evaluate the safety and efficacy of elezanumab and assess change in neurologic function in participants following an acute ischemic stroke.

Elezanumab is an investigational drug being developed for the treatment of acute ischemic stroke. This 52-week study is "double-blinded', which means that neither the participants nor the study doctors will know who will be given elezanumab and who will be given placebo (does not contain treatment drug). Participants will be assigned to one of two groups, called treatment arms. Participants in one arm will receive elezanumab and participants in the other arm will receive placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 120 subjects will be enrolled in 45 sites worldwide.

Participants will be randomized to elezanumab or placebo by intravenous (IV) infusion within 24 hours of "last known normal" (time when the participant was last known to be without signs and symptoms of the current stroke) and every 4 weeks thereafter for 48 weeks 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 elezanumab will be checked by medical assessments, blood tests, evaluation of side effects, and completion of questionnaires.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Elezanumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Australia
  • New South Wales
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital /ID# 239083
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital /ID# 240178
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital - Division of Hematology /ID# 218370
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • HHSC Hamilton General Hospital - David Braley Cardiac, Vascular and Stroke Resea /ID# 218970
• Japan
  • Fukuoka
    • Chikushino-shi, Fukuoka, Japan, 818-8502
      • Fukuoka University Chikushi Hospital /ID# 240629
    • Fukuoka-shi, Fukuoka, Japan, 811-0213
      • Fukuoka Wajiro Hospital /ID# 239810
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 892-0853
      • National Hospital Organization Kagoshima Medical Center /ID# 240021
  • Nagano
    • Nagano-shi, Nagano, Japan, 3818551
      • Nagano Municipal Hospital /ID# 240622
  • Yamaguchi
    • Hohu-shi, Yamaguchi, Japan, 747-8511
      • Yamaguchi Grand Medical Center /ID# 239892
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital /ID# 233769
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 233473
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center /ID# 234241
  • Gyeonggido
    • Seongnam si, Gyeonggido, Korea, Republic of, 13496
      • CHA University Bundang Medical Center /ID# 233503
• Spain
  • A Coruna, Spain, 15006
    • Hospital Universitario A Coruna - CHUAC /ID# 230080
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 217087
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 216380
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena /ID# 216382
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 216339
  • Guipuzcoa
    • Donostia, Guipuzcoa, Spain, 20014
      • Hospital Donostia /ID# 218034
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • OSI Ezkerraldea-Enkarterri-Cruces /ID# 217529
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona /ID# 214957
  • California
    • Long Beach, California, United States, 90808-1731
      • Long Beach Medical Center /ID# 217210
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital /ID# 216481
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic /ID# 217567
  • Illinois
    • Chicago, Illinois, United States, 60611-2927
      • Northwestern University Feinberg School of Medicine /ID# 215047
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center /ID# 216394
    • Louisville, Kentucky, United States, 40202
      • University of Louisville /ID# 217569
  • Massachusetts
    • Boston, Massachusetts, United States, 02111-1552
      • Tufts Medical Center /ID# 215053
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4500
      • University of Mississippi Medical Center /ID# 217587
  • Missouri
    • Kansas City, Missouri, United States, 64111-3220
      • St. Luke's Marion Bloch Neuroscience Institute /ID# 215028
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 214526
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Univ Med Ctr /ID# 218200
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131-0001
      • University of New Mexico School of Medicine /ID# 216827
  • New York
    • New York, New York, United States, 10032-3729
      • Columbia University Medical Center /ID# 215122
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • UH Cleveland Medical Center /ID# 215372
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus /ID# 214635
    • Columbus, Ohio, United States, 43210
      • The Ohio State University /ID# 215036
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network /ID# 242446
    • Philadelphia, Pennsylvania, United States, 19107-4414
      • Thomas Jefferson University /ID# 215469
  • Texas
    • Houston, Texas, United States, 77030-1501
      • University of Texas Health Science Center at Houston /ID# 215018
    • Temple, Texas, United States, 76508-0001
      • Baylor Scott & White Medical Center- Temple /ID# 225513
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia /ID# 215757

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of acute ischemic stroke, supported by acute brain computed tomography (CT) or magnetic resonance imaging (MRI) consistent with the clinical diagnosis.
• Able to randomize within 24 hours of last known normal.
• National Institute of Health Stroke Scale (NIHSS) total score of 7 to 21, inclusive.
• 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.

Exclusion Criteria:

• Evidence of severe stroke on imaging based on available acute imaging studies performed under the standard of care.
• Evidence of acute seizure at the onset of index stroke without conclusive imaging of ischemic stroke.
• Evidence of acute myocardial infarction.
• Symptoms are considered likely to resolve within the subsequent few hours (e.g., transient ischemic attack [TIA]).
• 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.
• Known medical history of repeated episodes of complex migraine. Participants with history of complex migraine, but with imaging conclusively demonstrating an acute ischemic stroke are still allowed.
• Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or for within 39 weeks (5 half-lives) after the last dose of study drug.
• Known receipt of any investigational product within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug. No current enrollment in another interventional clinical study, including pharmacologic and behavioral interventional studies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elezanumab; Participants will receive elezanumab dose A	Drug: Elezanumab; Intravenous (IV) infusion; Other Names: ABT-555
Placebo Comparator: Placebo; Participants will receive placebo for elezanumab	Drug: Placebo; Intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Stroke Scale (NIHSS) Total Score During the Treatment Period	The National Institutes of Health Stroke Scale (NIHSS) is a neurological examination used to quantitatively measure the severity of acute stroke by evaluating impact of cerebral infarction on level of consciousness, gaze, visual field, facial palsy, motor ability of arm and leg, limb ataxia, sensation, language, dysarthria, and extinction/inattention. Domains are scored on a scale of 0 to 2, 0 to 3, or 0 to 4, for a total range of 0 -42 points with higher scores indicating impairment.	Week 0 through Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Status based on Modified Rankin Scale (mRS)	The mRS is used to assess participant's disability and functional dependence. It is a 6-point scale ranging from 0 (no symptoms) to 5 (severe disability), with additional rating of 6 if the participant is deceased.	Week 0 through Week 52

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Estimated): January 29, 2025
• Study Completion (Estimated): February 23, 2025

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Elezanumab; ABT-555; Acute Ischemic Stroke; EAISE
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: M19-148; 2019-003753-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No