Back to resultsA Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
Primary Purpose
Acute Ischemic Stroke
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Elezanumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute Ischemic Stroke, ABT-555, Elezanumab, EAISE
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic Arizona /ID# 214957
- Long Beach Medical Center /ID# 217210
- Georgetown University Hospital /ID# 216481
- Mayo Clinic /ID# 217567
- Northwestern University Feinberg School of Medicine /ID# 215047
- University of Kentucky Chandler Medical Center /ID# 216394
- University of Louisville /ID# 217569
- Tufts Medical Center /ID# 215053
- University of Mississippi Medical Center /ID# 217587
- St. Luke's Marion Bloch Neuroscience Institute /ID# 215028
- Washington University-School of Medicine /ID# 214526
- Hackensack Univ Med Ctr /ID# 218200
- University of New Mexico School of Medicine /ID# 216827
- Columbia University Medical Center /ID# 215122
- UH Cleveland Medical Center /ID# 215372
- Cleveland Clinic Main Campus /ID# 214635
- The Ohio State University /ID# 215036
- Lehigh Valley Health Network /ID# 242446
- Thomas Jefferson University /ID# 215469
- University of Texas Health Science Center at Houston /ID# 215018
- Baylor Scott & White Medical Center- Temple /ID# 225513
- University of Virginia /ID# 215757
- Royal North Shore Hospital /ID# 239083
- The Royal Melbourne Hospital /ID# 240178
- University of Alberta Hospital - Division of Hematology /ID# 218370
- HHSC Hamilton General Hospital - David Braley Cardiac, Vascular and Stroke Resea /ID# 218970
- Fukuoka University Chikushi Hospital /ID# 240629
- Fukuoka Wajiro Hospital /ID# 239810
- National Hospital Organization Kagoshima Medical Center /ID# 240021
- Nagano Municipal Hospital /ID# 240622
- Yamaguchi Grand Medical Center /ID# 239892
- CHA University Bundang Medical Center /ID# 233503
- Pusan National University Hospital /ID# 233769
- Seoul National University Hospital /ID# 233473
- Samsung Medical Center /ID# 234241
- Hospital Donostia /ID# 218034
- OSI Ezkerraldea-Enkarterri-Cruces /ID# 217529
- Hospital Universitario A Coruna - CHUAC /ID# 230080
- Hospital Universitario Vall d'Hebron /ID# 217087
- Hospital Universitario La Paz /ID# 216380
- Hospital Universitario Virgen Macarena /ID# 216382
- Hospital Universitario Virgen del Rocio /ID# 216339
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Elezanumab
Placebo
Arm Description
Participants will receive elezanumab dose A
Participants will receive placebo for elezanumab
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04309474
Brief Title
A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
Official Title
A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
January 29, 2025 (Anticipated)
Study Completion Date
February 23, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Acute Ischemic Stroke, ABT-555, Elezanumab, EAISE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elezanumab
Arm Type
Experimental
Arm Description
Participants will receive elezanumab dose A
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo for elezanumab
Intervention Type
Drug
Intervention Name(s)
Elezanumab
Other Intervention Name(s)
ABT-555
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous (IV) infusion
Primary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale (NIHSS) Total Score During the Treatment Period
Description
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.
Time Frame
Week 0 through Week 52
Secondary Outcome Measure Information:
Title
Responder Status based on Modified Rankin Scale (mRS)
Description
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.
Time Frame
Week 0 through Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona /ID# 214957
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Long Beach Medical Center /ID# 217210
City
Long Beach
State/Province
California
ZIP/Postal Code
90808-1731
Country
United States
Facility Name
Georgetown University Hospital /ID# 216481
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Mayo Clinic /ID# 217567
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine /ID# 215047
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
University of Kentucky Chandler Medical Center /ID# 216394
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville /ID# 217569
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tufts Medical Center /ID# 215053
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Facility Name
University of Mississippi Medical Center /ID# 217587
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4500
Country
United States
Facility Name
St. Luke's Marion Bloch Neuroscience Institute /ID# 215028
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111-3220
Country
United States
Facility Name
Washington University-School of Medicine /ID# 214526
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack Univ Med Ctr /ID# 218200
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of New Mexico School of Medicine /ID# 216827
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
Columbia University Medical Center /ID# 215122
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Facility Name
UH Cleveland Medical Center /ID# 215372
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 214635
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University /ID# 215036
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Lehigh Valley Health Network /ID# 242446
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Thomas Jefferson University /ID# 215469
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4414
Country
United States
Facility Name
University of Texas Health Science Center at Houston /ID# 215018
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-1501
Country
United States
Facility Name
Baylor Scott & White Medical Center- Temple /ID# 225513
City
Temple
State/Province
Texas
ZIP/Postal Code
76508-0001
Country
United States
Facility Name
University of Virginia /ID# 215757
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Royal North Shore Hospital /ID# 239083
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
The Royal Melbourne Hospital /ID# 240178
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
University of Alberta Hospital - Division of Hematology /ID# 218370
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
HHSC Hamilton General Hospital - David Braley Cardiac, Vascular and Stroke Resea /ID# 218970
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Fukuoka University Chikushi Hospital /ID# 240629
City
Chikushino-shi
State/Province
Fukuoka
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Fukuoka Wajiro Hospital /ID# 239810
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-0213
Country
Japan
Facility Name
National Hospital Organization Kagoshima Medical Center /ID# 240021
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0853
Country
Japan
Facility Name
Nagano Municipal Hospital /ID# 240622
City
Nagano-shi
State/Province
Nagano
ZIP/Postal Code
3818551
Country
Japan
Facility Name
Yamaguchi Grand Medical Center /ID# 239892
City
Hohu-shi
State/Province
Yamaguchi
ZIP/Postal Code
747-8511
Country
Japan
Facility Name
CHA University Bundang Medical Center /ID# 233503
City
Seongnam si
State/Province
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Pusan National University Hospital /ID# 233769
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 233473
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 234241
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Hospital Donostia /ID# 218034
City
Donostia
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
OSI Ezkerraldea-Enkarterri-Cruces /ID# 217529
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario A Coruna - CHUAC /ID# 230080
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 217087
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 216380
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena /ID# 216382
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio /ID# 216339
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
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