A Phase 2 interventional study of Elezanumab and Placebo in Acute Ischemic Stroke, sponsored by AbbVie. Completed at 42 sites in 6 countries. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 931 are open to participants now.
This study's enrollment of 121 is close to the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive elezanumab 1800 mg
Drug: Elezanumab
Participants will receive placebo for elezanumab
Drug: Placebo
Intravenous (IV) infusion
Also known as: ABT-555
Intravenous (IV) infusion
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}.
Time frame: Day 1 through Week 52
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.
Time frame: Week 52
| Milestone | Placebo | Elezanumab |
|---|---|---|
| Started | 60 | 61 |
| Treated | 60 | 59 |
| Completed | 39 | 41 |
| Not completed | 21 | 20 |
| Withdrew: Randomized but not treated | 0 | 2 |
| Withdrew: Adverse event | 4 | 1 |
| Withdrew: Withdrawal by subject | 6 | 9 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Not disclosed | 10 | 6 |
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}.
| units on a scale | Placebo | Elezanumab |
|---|---|---|
| Analysis of the National Institutes of Health Stroke Scale (NIHSS) Total Score Area Under the Curve During the Treatment Period | 3.83 (2.642 to 5.024) | 3.13 (1.938 to 4.317) |
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.
| Participants | Placebo | Elezanumab |
|---|---|---|
| Responder Status Based on Modified Rankin Scale (mRS) | 28 | 29 |
Collected over All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 608.5 and 607 days for Placebo and Elezanumab 1800 mg, respectively.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 7/60 (11.7%) | 23/60 (38.3%) | 52/60 (86.7%) |
| Elezanumab | 1/61 (1.6%) | 18/61 (29.5%) | 49/61 (80.3%) |
| Event | Placebo | Elezanumab |
|---|---|---|
| BRAIN OEDEMANervous system disorders | 3/60 | 0/61 |
| ISCHAEMIC STROKENervous system disorders | 3/60 | 0/61 |
| PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders | 3/60 | 1/61 |
| FALLInjury, poisoning and procedural complications | 0/60 | 3/61 |
| COVID-19Infections and infestations | 2/60 | 1/61 |
| PNEUMONIAInfections and infestations | 2/60 | 0/61 |
| PNEUMONIA ASPIRATIONInfections and infestations | 2/60 | 1/61 |
| CEREBRAL INFARCTIONNervous system disorders | 2/60 | 1/61 |
| HAEMORRHAGIC TRANSFORMATION STROKENervous system disorders | 2/60 | 0/61 |
| CEREBROVASCULAR ACCIDENTNervous system disorders | 0/60 | 2/61 |
| Event | Placebo | Elezanumab |
|---|---|---|
| CONSTIPATIONGastrointestinal disorders | 13/60 | 11/61 |
| URINARY TRACT INFECTIONInfections and infestations | 11/60 | 13/61 |
| FALLInjury, poisoning and procedural complications | 11/60 | 5/61 |
| COVID-19Infections and infestations | 10/60 | 5/61 |
| HEADACHENervous system disorders | 10/60 | 7/61 |
| HYPERTENSIONVascular disorders | 10/60 | 4/61 |
| INSOMNIAPsychiatric disorders | 6/60 | 10/61 |
| ATRIAL FIBRILLATIONCardiac disorders | 8/60 | 6/61 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 8/60 | 6/61 |
| NAUSEAGastrointestinal disorders | 4/60 | 7/61 |
| Age, Customized(Participants) | Placebo | Elezanumab | Total |
|---|---|---|---|
| < 70 years | 27 | 25 | 52 |
| 70 to < 80 years | 18 | 19 | 37 |
| ≥ 80 years | 15 | 15 | 30 |
| Sex: Female, Male(Participants) | Placebo | Elezanumab | Total |
|---|---|---|---|
| Female | 32 | 24 | 56 |
| Male | 28 | 35 | 63 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Elezanumab | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 5 | 12 |
| Not Hispanic or Latino | 53 | 54 | 107 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | Elezanumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 9 | 10 | 19 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 8 |
| White | 46 | 45 | 91 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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