A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

— REvive  

Official title:

A Phase 2b, Multinational, Randomized, Double-blind Study to Investigate the Efficacy and Safety of Redasemtide (S-005151) Compared With Placebo in Adult Participants With Acute Ischemic Stroke Who Are Not Eligible for Tissue Pasminogen Activator or Thrombectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953480
• Other study ID #: 2138P2231
• Secondary ID: 2022-501890-38-0
• Status: Recruiting
• Phase: Phase 2
• Start date: July 14, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: Shionogi Inc.
• Contact: Shionogi Clinical Trials Administrator Clinical Support Help Lin
• Phone: 1-800-849-9707
• Email: Shionogiclintrials-admin[@]shionogi.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 627
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to initiate study intervention within 25 hours of stroke onset
• Determined by the investigator to not be eligible for recanalization thrombolysis or endovascular recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy) for the current stroke.
• Baseline NIHSS score of 8 to 22 (inclusive) and stable, defined as absence of an increase or decrease of = 4 points within = 1 hour to = 3 hours between screening and baseline assessment of NIHSS score.
• Medically stable at the time of enrollment except for primary disease and complications associated with it, according to the judgment of the investigator. In addition, hospitalization during the Follow-up Period is not anticipated, and the participant appears likely to be able to complete the study. Medically stable is defined as disease not requiring significant change in therapy for 3 months following enrollment.

Exclusion Criteria:

• Any disease or neurological disorder that, in the opinion of the investigator, would interfere with the conduct of the study
• A severe decrease in consciousness level (defined as NIHSS item 1a score 3: Not alert, responds only with reflex motor or autonomic effects, or totally unresponsive, flaccid, and areflexic)
• Disability corresponding to a mRS score of = 2 before the onset of stroke
• A history of stroke (excluding transient ischemic attack), history of or current intracranial hemorrhage, or head trauma that caused neurological effects within 90 days prior to obtaining informed consent
• Participants with an ischemic stroke in cerebellum and/or brain stem as the main infarction site
• Diagnosis of a current transient ischemic attack
• Unable to undergo either CT or MRI
• Considered by the investigator to be inappropriate to participate due to a history or complication of serious cardiovascular disease within 1 month of screening (for example, history of acute myocardial infarction, current acute myocardial infarction, uncontrollable heart failure, infective endocarditis requiring treatment, or acute aortic dissection, or requiring or likely to require hospitalization for severe arrhythmia during the study)
• Blood glucose level < 50 or > 400 milligrams/deciliter after glycemic control
• Systolic blood pressure = 220 millimeters of mercury (mmHg) or diastolic blood pressure = 120 mmHg after antihypertensive treatment
• Sensitivity to any of the study interventions, or components thereof, or clinically significant drug or other severe allergy that, in the opinion of the investigator, contraindicates participation in the study
• Use of prohibited concomitant medications or therapies listed in the protocol for the treatment of current AIS
• Participants who have previously received redasemtide
• Participants who have received any investigational product within 90 days of screening Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Biological:
• Redasemtide
Lyophilized white powder reconstituted in 0.9% saline for injection

Drug:
• Placebo
Lyophilized white powder reconstituted in 0.9% saline for injection

Locations

Country	Name	City	State
Australia	Liverpool Hospital - PPDS	Sydney	New South Wales
Hong Kong	Prince of Wales Hospital	New Territories
Israel	Assuta Ashdod Medical Center	Ashdod	HaDarom
Israel	Barzilai Medical Center	Ashkelon
Israel	Rambam Medical Center - PPDS	Haifa
Israel	Hadassah Medical Center - PPDS	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Israel	Meir Medical Center	Kfar Sava	HaMerkaz
Israel	Galilee Medical Center	Nahariya	HaZafon
Israel	Sheba Medical Center - PPDS	Ramat-Gan
Israel	ZIV Medical Center	Safed
Israel	Tel Aviv Sourasky Medical Center - PPDS	Tel Aviv-Yafo	Tel-Aviv
Japan	National Hospital Organization Toyohashi Medical Center	Aichi
Japan	Fukui Prefectural Hospital	Fukui
Japan	Our Lady of the Snow Social Medical Corporation St. Mary's Hospital	Fukuoka
Japan	Shin Komonji Hospital	Fukuoka
Japan	Social Medical Corporation Foundation Chiyuukai Fukuoka Wajiro Hospital	Fukuoka
Japan	National Hospital Organization Higashihiroshima Medical Center	Higashihiroshima-Shi	Hiroshima
Japan	Mazda Hospital of Mazda Motor Corporation	Hiroshima
Japan	National Hospital Organization Kure Medical Center and Chugoku Cancer Center	Hiroshima
Japan	Social Medical Corporation Hakuyoukai Kashiwaba Neurosurgical Hospital	Hokkaido
Japan	Hyogo Medical University Hospital	Hyogo
Japan	JA Toride Medical Center	Ibaraki
Japan	Tsukuba Medical Center Hospital	Ibaraki
Japan	Chutoen General Medical Center	Kakegawa-Shi	Sizuoka
Japan	National Hospital Organization Yokohama Medical Center	Kanagawa
Japan	Seisho Hospital	Kanagawa
Japan	Kimitsu Chuo Hospital	Kisaratsu	Chiba
Japan	Hyogo Medical University Hospital	Nishinomiya-Shi	Hyôgo
Japan	National Hospital Organization Beppu Medical Center	Oita
Japan	Ome Municipal General Hospital	Ome-Shi	Tokyo
Japan	Kotobuki Social Medical Corporation Tominaga Hospital	Osaka
Japan	National Cerebral and Cardiovascular Center	Osaka
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Osaka University Hospital	Osaka
Japan	Rinku General Medical Center	Osaka
Japan	Sainokuni Higashiomiya Medical Center	Saitama
Japan	Sainokuni Higashiomiya Medical Center	Saitama
Japan	National Hospital Organization Hamada Medical Center	Shimane
Japan	Chutoen General Medical Center	Shizuoka
Japan	Shizuoka City Shizuoka Hospital	Shizuoka
Japan	Shizuoka City Shizuoka Hospital	Shizuoka-Shi Aoi-Ku	Sizuoka
Japan	National Cerebral and Cardiovascular Center	Suita-Shi	Ôsaka
Japan	National Cerebral and Cardiovascular Center	Suita-Shi	Ôsaka
Japan	Takayama Red Cross Hospital	Takayama-Shi	Gifu
Japan	Federation of National Public Service Personnel Mutual Aid Associations Mishuku Hospital	Tokyo
Japan	Tokyo Metropolitan Bokutoh Hospital	Tokyo
Japan	Tokyo Women's Medical University Hospital	Tokyo
Japan	National Hospital Organization Yokohama Medical Center	Yokohama-Shi	Kanagawa
Japan	Sanyudo Hospital	Yonezawa-Shi	Yamagata
United States	Augusta University	Augusta	Georgia
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Baylor Scott & White - Plano Brain & Spine Center	Dallas	Texas
United States	Baylor Scott & White Research Institue	Dallas	Texas
United States	Nuvance Health Medical Practice, PC- Neurosurgery	Great Neck	New York
United States	Houston Methodist Hospital	Houston	Texas
United States	North Shore University Hospital-300 Community Dr	Manhasset	New York
United States	Community Hospital	Munster	Indiana
United States	Mercyhealth Javon Bea Hospital- Riverside	Rockford	Illinois
United States	Intercoastal Medical Group	Sarasota	Florida
United States	Ascension St. John Clinical Research Institute	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Countries where clinical trial is conducted

United States,  Australia,  Hong Kong,  Israel,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale (mRS) Score at Day 90		Day 90
Secondary	Number of Participants With mRS Score of 0 to 2		Day 90
Secondary	Number of Participants With Barthel Index (BI) Score = 95		Day 90
Secondary	mRS Score at Day 30		Day 30
Secondary	mRS Score at Day 180		Day 180
Secondary	Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score of 0 or 1		Days 1, 5, 30, 90, and 180
Secondary	Change From Baseline in NIHSS Score		Baseline, Days 1, 5, 30, 90, and 180
Secondary	Number of Participants With BI Score = 95		Days 5, 30, 90, and 180
Secondary	Change From Day 5 in Short Form 36-item Health Survey (SF-36) Score		Day 5, Days 90 and 180
Secondary	Change From Day 5 in Stroke and Aphasia Quality of Life Scale - 39 Item Generic Version (SAQoL-39g) Score		Day 5, Days 90 and 180
Secondary	Patient Global Impression of Change Scale (PGI-C) Score		Days 5, 90, and 180
Secondary	Change From Day 5 in Patient Global Impression of Severity Scale (PGI-S) Score		Day 5, Days 90 and 180