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

NCT04309474 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: M19-1482019-003753-29
• Study Type: interventional
• Target: 121
• Locations: 6 countries
• Sites: 42

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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; ABT-555; Elezanumab; EAISE

Outcome Measures

Primary Outcomes (1)

• 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}.

  Day 1 through Week 52

Secondary Outcomes (1)

• Responder Status Based on Modified Rankin Scale (mRS)

  Week 52

Study Arms (2)

Elezanumab

EXPERIMENTAL

Participants will receive elezanumab 1800 mg

Drug: Elezanumab

Placebo

PLACEBO COMPARATOR

Participants will receive placebo for elezanumab

Drug: Placebo

Interventions

Placebo DRUG

Intravenous (IV) infusion

Placebo

Elezanumab DRUG

Intravenous (IV) infusion

Also known as: ABT-555

Elezanumab

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (42)

Mayo Clinic Arizona /ID# 214957

Phoenix, Arizona, 85054, United States

Location

Long Beach Medical Center /ID# 217210

Long Beach, California, 90808-1731, United States

Location

Georgetown University Hospital /ID# 216481

Washington D.C., District of Columbia, 20007, United States

Location

Duplicate_Mayo Clinic /ID# 217567

Jacksonville, Florida, 32224, United States

Location

Northwestern University Feinberg School of Medicine /ID# 215047

Chicago, Illinois, 60611-2927, United States

Location

Duplicate_University of Kentucky Chandler Medical Center /ID# 216394

Lexington, Kentucky, 40536, United States

Location

University of Louisville Hospital /ID# 217569

Louisville, Kentucky, 40202, United States

Location

Tufts Medical Center /ID# 215053

Boston, Massachusetts, 02111-1552, United States

Location

University of Mississippi Medical Center /ID# 217587

Jackson, Mississippi, 39216-4500, United States

Location

St. Luke's Marion Bloch Neuroscience Institute /ID# 215028

Kansas City, Missouri, 64111-3220, United States

Location

Washington University-School of Medicine /ID# 214526

St Louis, Missouri, 63110, United States

Location

Hackensack Univ Med Ctr /ID# 218200

Hackensack, New Jersey, 07601, United States

Location

University of New Mexico School of Medicine /ID# 216827

Albuquerque, New Mexico, 87131-0001, United States

Location

Columbia University Medical Center /ID# 215122

New York, New York, 10032-3729, United States

Location

UH Cleveland Medical Center /ID# 215372

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Main Campus /ID# 214635

Cleveland, Ohio, 44195, United States

Location

The Ohio State University /ID# 215036

Columbus, Ohio, 43210, United States

Location

Lehigh Valley Health Network /ID# 242446

Allentown, Pennsylvania, 18103, United States

Location

Thomas Jefferson University Hospital /ID# 215469

Philadelphia, Pennsylvania, 19107, United States

Location

University of Texas Health Science Center at Houston /ID# 215018

Houston, Texas, 77030-1501, United States

Location

Baylor Scott & White Medical Center- Temple /ID# 225513

Temple, Texas, 76508-0001, United States

Location

University of Virginia /ID# 215757

Charlottesville, Virginia, 22908, United States

Location

Duplicate_Royal North Shore Hospital /ID# 239083

St Leonards, New South Wales, 2065, Australia

Location

The Royal Melbourne Hospital /ID# 240178

Parkville, Victoria, 3050, Australia

Location

University of Alberta Hospital /ID# 218370

Edmonton, Alberta, T6G 2B7, Canada

Location

Hamilton General Hospital /ID# 218970

Hamilton, Ontario, L8L 2X2, Canada

Location

Fukuoka University Chikushi Hospital /ID# 240629

Chikushino-shi, Fukuoka, 818-8502, Japan

Location

Fukuoka Wajiro Hospital /ID# 239810

Fukuoka, Fukuoka, 811-0213, Japan

Location

National Hospital Organization Kagoshima Medical Center /ID# 240021

Kagoshima, Kagoshima-ken, 892-0853, Japan

Location

Nagano Municipal Hospital /ID# 240622

Nagano, Nagano, 3818551, Japan

Location

Yamaguchi Grand Medical Center /ID# 239892

Hohu-shi, Yamaguchi, 747-8511, Japan

Location

Duplicate_Pusan National University Hospital /ID# 233769

Busan, Busan Gwang Yeogsi, 49241, South Korea

Location

Duplicate_CHA University Bundang Medical Center /ID# 233503

Seongnam-si, Gyeonggido, 13496, South Korea

Location

Seoul National University Hospital /ID# 233473

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Samsung Medical Center /ID# 234241

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Complejo Hospitalario Universitario A Coruña /ID# 230080

A Coruña, A Coruna, 15006, Spain

Location

Hospital Donostia /ID# 218034

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

OSI Ezkerraldea-Enkarterri-Cruces /ID# 217529

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Universitario Vall de Hebron /ID# 217087

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz /ID# 216380

Madrid, 28046, Spain

Location

Hospital Universitario Virgen Macarena /ID# 216382

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 216339

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

elezanumab

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: ABBVIE CALL CENTER
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

844-663-3742

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 16, 2020
• Study Start: November 9, 2020
• Primary Completion: April 18, 2024
• Study Completion: December 23, 2024
• Last Updated: December 22, 2025
• Results First Posted: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

KR (4); JP (5); US (22); AU (2); CA (2); ES (7)