Trial Outcomes & Findings for A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke (NCT NCT04309474)

Last Updated: 2025-12-22

Results Overview

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}.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

121 participants

Primary outcome timeframe

Day 1 through Week 52

Results posted on

2025-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants will receive placebo for elezanumab via Intravenous (IV) infusion.	Elezanumab Participants will receive elezanumab 1800 mg via Intravenous (IV) infusion.
Overall Study STARTED	60	61
Overall Study Treated	60	59
Overall Study COMPLETED	39	41
Overall Study NOT COMPLETED	21	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants will receive placebo for elezanumab via Intravenous (IV) infusion.	Elezanumab Participants will receive elezanumab 1800 mg via Intravenous (IV) infusion.
Overall Study Randomized but not treated	0	2
Overall Study Adverse Event	4	1
Overall Study Withdrawal by Subject	6	9
Overall Study Lost to Follow-up	1	2
Overall Study Not disclosed	10	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=60 Participants Participants will receive placebo for elezanumab via Intravenous (IV) infusion.	Elezanumab n=59 Participants Participants will receive elezanumab 1800 mg via Intravenous (IV) infusion.	Total n=119 Participants Total of all reporting groups
Age, Customized < 70 years	27 Participants n=18 Participants	25 Participants n=102 Participants	52 Participants n=30 Participants
Age, Customized 70 to < 80 years	18 Participants n=18 Participants	19 Participants n=102 Participants	37 Participants n=30 Participants
Age, Customized ≥ 80 years	15 Participants n=18 Participants	15 Participants n=102 Participants	30 Participants n=30 Participants
Sex: Female, Male Female	32 Participants n=18 Participants	24 Participants n=102 Participants	56 Participants n=30 Participants
Sex: Female, Male Male	28 Participants n=18 Participants	35 Participants n=102 Participants	63 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=18 Participants	5 Participants n=102 Participants	12 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=18 Participants	54 Participants n=102 Participants	107 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Asian	9 Participants n=18 Participants	10 Participants n=102 Participants	19 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	4 Participants n=18 Participants	4 Participants n=102 Participants	8 Participants n=30 Participants
Race (NIH/OMB) White	46 Participants n=18 Participants	45 Participants n=102 Participants	91 Participants n=30 Participants
Race (NIH/OMB) More than one race	1 Participants n=18 Participants	0 Participants n=102 Participants	1 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants

PRIMARY outcome

Timeframe: Day 1 through Week 52

Population: Full Analysis Set Note: The AUC for each treatment group, as well as the difference in AUCs (placebo minus elezanumab) and their respective standard errors and confidence intervals are presented.

Outcome measures

Outcome measures
Measure	Placebo n=60 Participants Participants will receive placebo for elezanumab via Intravenous (IV) infusion.	Elezanumab n=59 Participants Participants will receive elezanumab 1800 mg via Intravenous (IV) infusion.
Analysis of the National Institutes of Health Stroke Scale (NIHSS) Total Score Area Under the Curve During the Treatment Period	3.83 units on a scale Interval 2.642 to 5.024	3.13 units on a scale Interval 1.938 to 4.317

SECONDARY outcome

Timeframe: Week 52

Population: Full Analysis Set N indicates the number of subjects with non-missing values at each time point.

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.

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants Participants will receive placebo for elezanumab via Intravenous (IV) infusion.	Elezanumab n=38 Participants Participants will receive elezanumab 1800 mg via Intravenous (IV) infusion.
Responder Status Based on Modified Rankin Scale (mRS)	28 Participants	29 Participants

Adverse Events

Placebo

Serious events: 23 serious events

Other events: 52 other events

Deaths: 7 deaths

Elezanumab

Serious events: 18 serious events

Other events: 49 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

ABBVIE CALL CENTER

AbbVie

Phone: 844-663-3742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=60 participants at risk Participants will receive placebo for elezanumab via Intravenous (IV) infusion.	Elezanumab n=61 participants at risk Participants will receive elezanumab 1800 mg via Intravenous (IV) infusion.
Cardiac disorders ATRIAL FIBRILLATION	13.3% 8/60 • Number of events 10 • 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.	9.8% 6/61 • Number of events 6 • 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.
Cardiac disorders BRADYCARDIA	6.7% 4/60 • Number of events 5 • 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.	1.6% 1/61 • Number of events 1 • 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.
Eye disorders DRY EYE	5.0% 3/60 • Number of events 3 • 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.	1.6% 1/61 • Number of events 1 • 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.
Gastrointestinal disorders CONSTIPATION	21.7% 13/60 • Number of events 14 • 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.	18.0% 11/61 • Number of events 13 • 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.
Gastrointestinal disorders DIARRHOEA	6.7% 4/60 • Number of events 4 • 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.	6.6% 4/61 • Number of events 4 • 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.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	5.0% 3/60 • Number of events 3 • 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.	0.00% 0/61 • 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.
Gastrointestinal disorders NAUSEA	6.7% 4/60 • Number of events 4 • 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.	11.5% 7/61 • Number of events 7 • 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.
General disorders FATIGUE	5.0% 3/60 • Number of events 3 • 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.	1.6% 1/61 • Number of events 1 • 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.
General disorders OEDEMA PERIPHERAL	10.0% 6/60 • Number of events 6 • 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.	1.6% 1/61 • Number of events 1 • 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.
General disorders PERIPHERAL SWELLING	6.7% 4/60 • Number of events 4 • 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.	0.00% 0/61 • 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.
General disorders PYREXIA	5.0% 3/60 • Number of events 3 • 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.	1.6% 1/61 • Number of events 1 • 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.
Infections and infestations COVID-19	16.7% 10/60 • Number of events 10 • 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.	8.2% 5/61 • Number of events 5 • 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.
Infections and infestations URINARY TRACT INFECTION	18.3% 11/60 • Number of events 16 • 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.	21.3% 13/61 • Number of events 16 • 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.
Injury, poisoning and procedural complications FALL	18.3% 11/60 • Number of events 15 • 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.	8.2% 5/61 • Number of events 7 • 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.
Injury, poisoning and procedural complications SKIN LACERATION	5.0% 3/60 • Number of events 3 • 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.	6.6% 4/61 • Number of events 6 • 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.
Metabolism and nutrition disorders DIABETES MELLITUS	8.3% 5/60 • Number of events 5 • 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.	1.6% 1/61 • Number of events 1 • 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.
Metabolism and nutrition disorders HYPOKALAEMIA	8.3% 5/60 • Number of events 5 • 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.	8.2% 5/61 • Number of events 5 • 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.
Musculoskeletal and connective tissue disorders ARTHRALGIA	13.3% 8/60 • Number of events 9 • 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.	9.8% 6/61 • Number of events 6 • 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.
Musculoskeletal and connective tissue disorders BACK PAIN	6.7% 4/60 • Number of events 4 • 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.	4.9% 3/61 • Number of events 3 • 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.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	6.7% 4/60 • Number of events 4 • 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.	3.3% 2/61 • Number of events 2 • 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.
Nervous system disorders DIZZINESS	5.0% 3/60 • Number of events 4 • 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.	9.8% 6/61 • Number of events 6 • 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.
Nervous system disorders HAEMORRHAGIC TRANSFORMATION STROKE	8.3% 5/60 • Number of events 5 • 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.	11.5% 7/61 • Number of events 7 • 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.
Nervous system disorders HEADACHE	16.7% 10/60 • Number of events 11 • 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.	11.5% 7/61 • Number of events 8 • 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.
Nervous system disorders SYNCOPE	8.3% 5/60 • Number of events 6 • 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.	1.6% 1/61 • Number of events 1 • 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.
Psychiatric disorders ANXIETY	8.3% 5/60 • Number of events 6 • 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.	9.8% 6/61 • Number of events 6 • 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.
Psychiatric disorders DEPRESSED MOOD	5.0% 3/60 • Number of events 4 • 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.	6.6% 4/61 • Number of events 6 • 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.
Psychiatric disorders DEPRESSION	5.0% 3/60 • Number of events 3 • 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.	8.2% 5/61 • Number of events 5 • 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.
Psychiatric disorders INSOMNIA	10.0% 6/60 • Number of events 6 • 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.	16.4% 10/61 • Number of events 10 • 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.
Renal and urinary disorders ACUTE KIDNEY INJURY	5.0% 3/60 • Number of events 3 • 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.	0.00% 0/61 • 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.
Renal and urinary disorders HAEMATURIA	1.7% 1/60 • Number of events 1 • 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.	8.2% 5/61 • Number of events 6 • 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.
Renal and urinary disorders URINARY RETENTION	1.7% 1/60 • Number of events 1 • 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.	6.6% 4/61 • Number of events 4 • 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.
Skin and subcutaneous tissue disorders RASH	6.7% 4/60 • Number of events 5 • 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.	6.6% 4/61 • Number of events 4 • 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.
Vascular disorders HYPERTENSION	16.7% 10/60 • Number of events 13 • 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.	6.6% 4/61 • Number of events 4 • 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.
Vascular disorders HYPOTENSION	3.3% 2/60 • Number of events 2 • 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.	6.6% 4/61 • Number of events 4 • 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.