A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
NCT ID: NCT04309474
Last Updated: 2025-12-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2020-11-09
2024-12-23
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Elezanumab
Participants will receive elezanumab 1800 mg
Elezanumab
Intravenous (IV) infusion
Placebo
Participants will receive placebo for elezanumab
Placebo
Intravenous (IV) infusion
Interventions
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Elezanumab
Intravenous (IV) infusion
Placebo
Intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
30 Years
90 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Mayo Clinic Arizona /ID# 214957
Phoenix, Arizona, United States
Long Beach Medical Center /ID# 217210
Long Beach, California, United States
Georgetown University Hospital /ID# 216481
Washington D.C., District of Columbia, United States
Duplicate_Mayo Clinic /ID# 217567
Jacksonville, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 215047
Chicago, Illinois, United States
Duplicate_University of Kentucky Chandler Medical Center /ID# 216394
Lexington, Kentucky, United States
University of Louisville Hospital /ID# 217569
Louisville, Kentucky, United States
Tufts Medical Center /ID# 215053
Boston, Massachusetts, United States
University of Mississippi Medical Center /ID# 217587
Jackson, Mississippi, United States
St. Luke's Marion Bloch Neuroscience Institute /ID# 215028
Kansas City, Missouri, United States
Washington University-School of Medicine /ID# 214526
St Louis, Missouri, United States
Hackensack Univ Med Ctr /ID# 218200
Hackensack, New Jersey, United States
University of New Mexico School of Medicine /ID# 216827
Albuquerque, New Mexico, United States
Columbia University Medical Center /ID# 215122
New York, New York, United States
UH Cleveland Medical Center /ID# 215372
Cleveland, Ohio, United States
Cleveland Clinic Main Campus /ID# 214635
Cleveland, Ohio, United States
The Ohio State University /ID# 215036
Columbus, Ohio, United States
Lehigh Valley Health Network /ID# 242446
Allentown, Pennsylvania, United States
Thomas Jefferson University Hospital /ID# 215469
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at Houston /ID# 215018
Houston, Texas, United States
Baylor Scott & White Medical Center- Temple /ID# 225513
Temple, Texas, United States
University of Virginia /ID# 215757
Charlottesville, Virginia, United States
Duplicate_Royal North Shore Hospital /ID# 239083
St Leonards, New South Wales, Australia
The Royal Melbourne Hospital /ID# 240178
Parkville, Victoria, Australia
University of Alberta Hospital /ID# 218370
Edmonton, Alberta, Canada
Hamilton General Hospital /ID# 218970
Hamilton, Ontario, Canada
Fukuoka University Chikushi Hospital /ID# 240629
Chikushino-shi, Fukuoka, Japan
Fukuoka Wajiro Hospital /ID# 239810
Fukuoka, Fukuoka, Japan
National Hospital Organization Kagoshima Medical Center /ID# 240021
Kagoshima, Kagoshima-ken, Japan
Nagano Municipal Hospital /ID# 240622
Nagano, Nagano, Japan
Yamaguchi Grand Medical Center /ID# 239892
Hohu-shi, Yamaguchi, Japan
Duplicate_Pusan National University Hospital /ID# 233769
Busan, Busan Gwang Yeogsi, South Korea
Duplicate_CHA University Bundang Medical Center /ID# 233503
Seongnam-si, Gyeonggido, South Korea
Seoul National University Hospital /ID# 233473
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 234241
Seoul, Seoul Teugbyeolsi, South Korea
Complejo Hospitalario Universitario A Coruña /ID# 230080
A Coruña, A Coruna, Spain
Hospital Donostia /ID# 218034
Donostia / San Sebastian, Guipuzcoa, Spain
OSI Ezkerraldea-Enkarterri-Cruces /ID# 217529
Barakaldo, Vizcaya, Spain
Hospital Universitario Vall de Hebron /ID# 217087
Barcelona, , Spain
Hospital Universitario La Paz /ID# 216380
Madrid, , Spain
Hospital Universitario Virgen Macarena /ID# 216382
Seville, , Spain
Hospital Universitario Virgen del Rocio /ID# 216339
Seville, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-003753-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M19-148
Identifier Type: -
Identifier Source: org_study_id