Acute Ischemic StrokePhase 2EAISENCT04309474
A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
A Phase 2 study testing Elezanumab in people with Acute Ischemic Stroke, run by AbbVie at 42 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Elezanumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 42 sitesin 6 countries
- Study dates
- 9 Nov 2020to 23 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
42 sites in 6 countries.
42 sites in 6 countries
United States22 sites
University of New Mexico School of Medicine /ID# 216827
Albuquerque, New Mexico, 87131-0001
Lehigh Valley Health Network /ID# 242446
Allentown, Pennsylvania, 18103
Tufts Medical Center /ID# 215053
Boston, Massachusetts, 02111-1552
University of Virginia /ID# 215757
Charlottesville, Virginia, 22908
Northwestern University Feinberg School of Medicine /ID# 215047
Chicago, Illinois, 60611-2927
UH Cleveland Medical Center /ID# 215372
Cleveland, Ohio, 44106
Cleveland Clinic Main Campus /ID# 214635
Cleveland, Ohio, 44195
The Ohio State University /ID# 215036
Columbus, Ohio, 43210
Hackensack Univ Med Ctr /ID# 218200
Hackensack, New Jersey, 07601
University of Texas Health Science Center at Houston /ID# 215018
Houston, Texas, 77030-1501
University of Mississippi Medical Center /ID# 217587
Jackson, Mississippi, 39216-4500
Duplicate_Mayo Clinic /ID# 217567
Jacksonville, Florida, 32224
St. Luke's Marion Bloch Neuroscience Institute /ID# 215028
Kansas City, Missouri, 64111-3220
Duplicate_University of Kentucky Chandler Medical Center /ID# 216394
Lexington, Kentucky, 40536
Long Beach Medical Center /ID# 217210
Long Beach, California, 90808-1731
University of Louisville Hospital /ID# 217569
Louisville, Kentucky, 40202
Columbia University Medical Center /ID# 215122
New York, New York, 10032-3729
Thomas Jefferson University Hospital /ID# 215469
Philadelphia, Pennsylvania, 19107
Mayo Clinic Arizona /ID# 214957
Phoenix, Arizona, 85054
Washington University-School of Medicine /ID# 214526
St Louis, Missouri, 63110
Baylor Scott & White Medical Center- Temple /ID# 225513
Temple, Texas, 76508-0001
Georgetown University Hospital /ID# 216481
Washington D.C., District of Columbia, 20007
Spain7 sites
Complejo Hospitalario Universitario A Coruña /ID# 230080
A Coruña, A Coruna, 15006
OSI Ezkerraldea-Enkarterri-Cruces /ID# 217529
Barakaldo, Vizcaya, 48903
Hospital Universitario Vall de Hebron /ID# 217087
Barcelona, 08035
Hospital Donostia /ID# 218034
Donostia / San Sebastian, Guipuzcoa, 20014
Hospital Universitario La Paz /ID# 216380
Madrid, 28046
Hospital Universitario Virgen Macarena /ID# 216382
Seville, 41009
Hospital Universitario Virgen del Rocio /ID# 216339
Seville, 41013
Japan5 sites
Fukuoka University Chikushi Hospital /ID# 240629
Chikushino-shi, Fukuoka, 818-8502
Fukuoka Wajiro Hospital /ID# 239810
Fukuoka, Fukuoka, 811-0213
Yamaguchi Grand Medical Center /ID# 239892
Hohu-shi, Yamaguchi, 747-8511
National Hospital Organization Kagoshima Medical Center /ID# 240021
Kagoshima, Kagoshima-ken, 892-0853
Nagano Municipal Hospital /ID# 240622
Nagano, Nagano, 3818551
South Korea4 sites
Duplicate_Pusan National University Hospital /ID# 233769
Busan, Busan Gwang Yeogsi, 49241
Duplicate_CHA University Bundang Medical Center /ID# 233503
Seongnam-si, Gyeonggido, 13496
Seoul National University Hospital /ID# 233473
Seoul, Seoul Teugbyeolsi, 03080
Samsung Medical Center /ID# 234241
Seoul, Seoul Teugbyeolsi, 06351
Australia2 sites
The Royal Melbourne Hospital /ID# 240178
Parkville, Victoria, 3050
Duplicate_Royal North Shore Hospital /ID# 239083
St Leonards, New South Wales, 2065
Canada2 sites
University of Alberta Hospital /ID# 218370
Edmonton, Alberta, T6G 2B7
Hamilton General Hospital /ID# 218970
Hamilton, Ontario, L8L 2X2
About this study
Official title: 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.
Read more
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Elezanumab, Placebo
- Keywords
- Acute Ischemic Stroke, ABT-555, Elezanumab, EAISE
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElezanumabDrug
Also called ABT-555
Intravenous (IV) infusion
PlaceboDrug
Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Elezanumab | Experimental | Participants will receive elezanumab 1800 mg Receives: Drug: Elezanumab |
| Placebo | Placebo comparator | Participants will receive placebo for elezanumab Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the National Institutes of Health Stroke Scale (NIHSS) Total Score Area Under the Curve 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 to 42 points with higher scores indicating impairment.
The monthly-adjusted AUC of the NIHSS total score for each treatment group was derived using the trapezoidal method and contrasts from a Mixed Model with Repeated Measures (MMRM). Please refer to the formula for AUCi in the Statistical Analysis Plan (SAP) where i = treatment group (placebo, elezanumab) and j = visit during the Treatment Period {Day 1, Day 2-4, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52}.
Measured: Day 1 through Week 52
Secondary outcomes (1)
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.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start9 Nov 2020
- Primary completion18 Apr 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309474
- Sponsor's protocol ID
- M19-148
- Other IDs
- 2019-003753-29, 2019
- Acronym
- EAISE
- Status last verified
- Dec 2025
- First submitted
- 13 Mar 2020
- Last updated
- 22 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04309474
- Acronym / sponsor ID
- EAISE / M19-148
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, ABT-555, Elezanumab, EAISE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Posted 22 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elezanumab | Experimental | Drug: ElezanumabParticipants will receive elezanumab 1800 mg |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo for elezanumab |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElezanumabAlso: ABT-555Intravenous (IV) infusion | Drug | Elezanumab |
| PlaceboIntravenous (IV) infusion | Drug | Placebo |
Primary outcome
Analysis of the National Institutes of Health Stroke Scale (NIHSS) Total Score Area Under the Curve During the Treatment Period
Time frame: Day 1 through Week 52
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 to 42 points with higher scores indicating impairment. The monthly-adjusted AUC of the NIHSS total score for each treatment group was derived using the trapezoidal method and contrasts from a Mixed Model with Repeated Measures (MMRM). Please refer to the formula for AUCi in the Statistical Analysis Plan (SAP) where i = treatment group (placebo, elezanumab) and j = visit during the Treatment Period {Day 1, Day 2-4, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52}.
1 secondary outcome
Responder Status Based on Modified Rankin Scale (mRS)
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
42 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elezanumab in people with Acute Ischemic Stroke, run by AbbVie at 42 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Spain, Japan, South Korea, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the National Institutes of Health Stroke Scale (NIHSS) Total Score Area Under the Curve During the Treatment Period (time frame: Day 1 through Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.