Clinical trial NCT04309474: A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
Official title: A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
ABT-555
Elezanumab
EAISE
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-03-16
Enrollment: 121
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS) Total Score During the Treatment Period
timeFrame: Week 0 through Week 52
Secondary outcomes:
measure: Responder Status based on Modified Rankin Scale (mRS)
timeFrame: Week 0 through Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona /ID# 214957
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Medical Center /ID# 217210
state: California
city: Washington
country: United States
facility: Georgetown University Hospital /ID# 216481
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic /ID# 217567
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 215047
state: Illinois
city: Lexington
country: United States
facility: Duplicate_University of Kentucky Chandler Medical Center /ID# 216394
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital /ID# 217569
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center /ID# 215053
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi Medical Center /ID# 217587
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Marion Bloch Neuroscience Institute /ID# 215028
state: Missouri
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 214526
state: Missouri
city: Hackensack
country: United States
facility: Hackensack Univ Med Ctr /ID# 218200
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico School of Medicine /ID# 216827
state: New Mexico
city: New York
country: United States
facility: Columbia University Medical Center /ID# 215122
state: New York
city: Cleveland
country: United States
facility: UH Cleveland Medical Center /ID# 215372
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus /ID# 214635
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University /ID# 215036
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Health Network /ID# 242446
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital /ID# 215469
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston /ID# 215018
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center- Temple /ID# 225513
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia /ID# 215757
state: Virginia
city: St Leonards
country: Australia
facility: Royal North Shore Hospital /ID# 239083
state: New South Wales
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 240178
state: Victoria
city: Edmonton
country: Canada
facility: University of Alberta Hospital /ID# 218370
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton General Hospital /ID# 218970
state: Ontario
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital /ID# 240629
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Fukuoka Wajiro Hospital /ID# 239810
state: Fukuoka
city: Kagoshima-shi
country: Japan
facility: National Hospital Organization Kagoshima Medical Center /ID# 240021
state: Kagoshima
city: Nagano-shi
country: Japan
facility: Nagano Municipal Hospital /ID# 240622
state: Nagano
city: Hohu-shi
country: Japan
facility: Yamaguchi Grand Medical Center /ID# 239892
state: Yamaguchi
city: Busan
country: Korea, Republic of
facility: Duplicate_Pusan National University Hospital /ID# 233769
state: Busan Gwang Yeogsi
city: Seongnam si
country: Korea, Republic of
facility: Duplicate_CHA University Bundang Medical Center /ID# 233503
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 233473
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 234241
state: Seoul Teugbyeolsi
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña /ID# 230080
state: A Coruna
city: Donostia
country: Spain
facility: Hospital Donostia /ID# 218034
state: Guipuzcoa
city: Barakaldo
country: Spain
facility: OSI Ezkerraldea-Enkarterri-Cruces /ID# 217529
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 217087
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 216380
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena /ID# 216382
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 216339
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: