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

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

The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS). This study consists of 2 cohorts, Cohort A and Cohort B. Cohort A (redasemtide or placebo) will enroll participants who are ineligible for systemic thrombolysis and/or mechanical recanalization therapy. Cohort B (redasemtide or placebo) will enroll participants who are eligible to receive or who have received systemic thrombolysis and/or mechanical recanalization therapy as standard of care.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Biological: Redasemtide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 680
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2170
      • Liverpool Hospital - PPDS
  • Queensland
    • Southport, Queensland, Australia, 4215
      • Gold Coast University Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Parkville, Victoria, Australia, 3052
      • Royal Melbourne Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Belgium
  • Brussels Capital
    • Jette, Brussels Capital, Belgium, 1090
      • UZ Brussel - PIN
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent
  • West-Vlaanderen
    • Ostend, West-Vlaanderen, Belgium, 8400
      • AZ Oostende - Damiaan
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Beijing Tiantan Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 102218
      • Beijing Tsinghua Changgung Hospital
    • Beijing, Beijing Municipality, China, 100053
      • Xuanwu Hospital Capital Medical University
    • Beijing, Beijing Municipality, China, 101199
      • Beijing Luhe Hospital, Capital Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210001
      • Nanjing First Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
• Czechia
  • Prague, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Nové Město
    • Prague, Nové Město, Czechia, 101 00
      • Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2
  • Praha, Hlavní Mesto
    • Prague, Praha, Hlavní Mesto, Czechia, 100 00
      • Fakultni nemocnice Kralovske Vinohrady
• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 290
      • Helsingin yliopistollinen sairaala
• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 4103
      • Universitätsklinikum Leipzig
  • Thuringia
    • Altenburg, Thuringia, Germany, 4600
      • Klinikum Altenburger Land GmbH
• Greece
  • Athens, Greece, 12462
    • University General Hospital ''ATTIKON''
  • Ioannina, Greece, 455 00
    • University General Hospital of Ioannina
  • Larissa, Greece, 411 10
    • University General Hospital of Larissa
  • Thessaloniki, Greece, 56429
    • Papageorgiou General Hospital Of Thessaloniki
  • Thessaloniki, Greece, 546 36
    • AHEPA University General Hospital of Thessaloniki
  • Thessaloniki, Greece, 546 42
    • General Hospital of Thessaloniki ''Hippokratio''
  • Thessaloniki, Greece, 570 10
    • General Hospital of Thessaloniki ''G. Papanikolaou''
  • Achaïa
    • Pátrai, Achaïa, Greece, 265 04
      • University General Hospital of Patras
  • Attica
    • Athens, Attica, Greece, 115 21
      • Naval Hospital of Athens
    • Athens, Attica, Greece, 11528
      • Alexandra Hospital
  • Evros
    • Alexandroupoli, Evros, Greece, 681 00
      • University General Hospital of Alexandroupolis
  • Irakleio
    • Heraklion, Irakleio, Greece, 710 03
      • University General Hospital of Heraklion
• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Queen Mary Hospital - PPDS
  • Kwai Chung, Hong Kong, 999077
    • Princess Margaret Hospital - Hong Kong
  • Shatin, Hong Kong, 999077
    • Prince of Wales Hospital
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Budapest, Hungary, 1106
    • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
  • Budapest, Hungary, 1145
    • Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika
  • Győr, Hungary, 9024
    • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
  • Baranya
    • Pécs, Baranya, Hungary, 7624
      • Pécsi Tudomanyegyetem - Vasvari Pal u.
  • Borsod-Abauj Zemplen county
    • Miskolc, Borsod-Abauj Zemplen county, Hungary, 3526
      • Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
  • Pest County
    • Kistarcsa, Pest County, Hungary, 2143
      • Kistarcsai Flor Ferenc Korhaz
  • Szabolcs-Szatmár-Bereg
    • Kisvárda, Szabolcs-Szatmár-Bereg, Hungary, 4600
      • Szent Damjan Gorogkatolikus Korhaz
• Israel
  • Ashkelon, Israel, 7830604
    • Barzilai Medical Center
  • Haifa, Israel, 31096
    • Rambam Medical Center - PPDS
  • Ramat Gan, Israel, 5262000
    • Sheba Medical Center - PPDS
  • Safed, Israel, 13100
    • Ziv Medical Center
  • Central District
    • Kfar Saba, Central District, Israel, 44281
      • Meir Medical Center
  • Haifa District
    • Hadera, Haifa District, Israel, 38100
      • Hillel Yaffe Medical Center
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 91120
      • Hadassah Medical Center - PPDS
  • Northern District
    • Nahariya, Northern District, Israel, 2210000
      • Galilee Medical Center
  • Tel Aviv
    • Tel Aviv, Tel Aviv, Israel, 64239
      • Tel Aviv Sourasky Medical Center - PPDS
• Japan
  • Aichi-ken
    • Toyohashi, Aichi-ken, Japan, 440-8510
      • National Hospital Organization Toyohashi Medical Center
  • Chiba
    • Kisarazu, Chiba, Japan, 292-8535
      • Kimitsu Chuo Hospital
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 811-0213
      • Social Medical Corporation The Chiyukai Foundation Fukuoka Wajiro Hospital
    • Kitakyushu-Shi, Fukuoka, Japan, 800-0057
      • Shin Komonji Hospital
    • Omuta-Shi, Fukuoka, Japan, 836-8567
      • Omuta City Hospital
  • Gifu
    • Takayama-Shi, Gifu, Japan, 506-8550
      • Japanese Red Cross Takayama Hospital
  • Hiroshima
    • Higashihiroshima-Shi, Hiroshima, Japan, 739-0041
      • National Hospital Organization Higashihiroshima Medical Center
    • Kure-Shi, Hiroshima, Japan, 737-0023
      • National Hospital Organization Kure Medical Center and Chugoku Cancer Center
  • Hukui
    • Fukui-shi, Hukui, Japan, 910-8526
      • Fukui Prefectural Hospital
  • Hukuoka
    • Kurume-Shi, Hukuoka, Japan, 830-8543
      • Our Lady of the Snow Social Medical Corporation St. Mary's Hospital
  • Hyôgo
    • Kobe, Hyôgo, Japan, 654-0048
      • Shinsuma General Hospital
    • Nishinomiya-Shi, Hyôgo, Japan, 663-8501
      • Hyogo Medical University Hospital
  • Kanagawa
    • Odawara-Shi, Kanagawa, Japan, 250-0001
      • Seisho Hospital
    • Yokohama, Kanagawa, Japan, 245-8575
      • National Hospital Organization Yokohama Medical Center
  • Oita Prefecture
    • Beppu-Shi, Oita Prefecture, Japan, 874-0011
      • National Hospital Organization Beppu Medical Center
  • Osaka
    • Izumisano, Osaka, Japan, 598-8577
      • Rinku General Medical Center
    • Osaka, Osaka, Japan, 540-0006
      • National Hospital Organization Osaka National Hospital
    • Osaka, Osaka, Japan, 556-0017
      • Tominaga Hospital
    • Suita-Shi, Osaka, Japan, 565-0871
      • Osaka University Hospital
    • Suita-Shi, Osaka, Japan, 564-8565
      • National Cerebral and Cardiovascular Center
  • Saitama
    • Kuki-shi, Saitama, Japan, 346-8530
      • Shin-Kuki General Hospital
  • Shimane
    • Hamada-Shi, Shimane, Japan, 697-8511
      • National Hospital Organization Hamada Medical Center
  • Shizuoka
    • Aoi-Ku, Shizuoka, Japan, 420-8630
      • Shizuoka City Shizuoka Hospital
    • Hamamatsu, Shizuoka, Japan, 430-8525
      • Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital
    • Kakegawa-Shi, Shizuoka, Japan, 436-8555
      • Chutoen General Medical Center
  • Tokyo
    • Meguro-Ku, Tokyo, Japan, 153-0051
      • Misyuku Hospital
  • Yamagata
    • Yonezawa-Shi, Yamagata, Japan, 992-0033
      • Sanyudo Hospital
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • University Clinical Center of Serbia - Pasterova 2 - PPDS
  • Belgrade, Serbia, 11000
    • Hospital for Cerebrovascular Diseases Sveti Sava
  • Bor, Serbia, 19210
    • General Hospital Bor
  • Leskovac, Serbia, 16000
    • General Hospital Leskovac
  • Niš, Serbia, 18 000
    • University Clinical Center Nis
  • Novi Sad, Serbia, 21000
    • Clinical Centre of Vojvodina
  • Užice, Serbia, 31000
    • Health Center Uzice
  • Valjevo, Serbia, 250804
    • Health Center Valjevo
  • Zrenjanin, Serbia, 23000
    • General Hospital Dr. Djordje Joanovic - Zrenjanin
  • Ćuprija, Serbia, 35230
    • General Hospital Cuprija
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital (SGH)
  • Singapore, Singapore, 119074
    • National University Hospital- Singapore
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Seoul, South Korea, 6351
    • Samsung Medical Center
  • Seoul, South Korea, 3722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 2447
    • Kyung Hee University Hospital
  • Seoul, South Korea, 4763
    • Hanyang University Medical Center
  • Daegu Gwang'yeogsi
    • Daegu, Daegu Gwang'yeogsi, South Korea, 42601
      • Keimyung University Dongsan Hospital
  • Gyeonggido
    • Goyang-si, Gyeonggido, South Korea, 10380
      • Inje University Ilsan Paik Hospital
• Spain
  • A Coruña, Spain, 15006
    • Hospital Universitario A Coruna
  • Almería, Spain, 4009
    • Hospital Universitario Torrecárdenas
  • Badajoz, Spain, 6006
    • Hospital Universitario de Badajoz
  • Barcelona, Spain, 8035
    • Hospital Universitario Vall d'Hebron - PPDS
  • Barcelona, Spain, 8025
    • Hospital de la Santa Creu i Sant Pau
  • El Palmar, Spain, 30120
    • Hospital Universitario Virgen de La Arrixaca
  • Girona, Spain, 17007
    • Hospital Universitari de Girona Dr Josep Trueta
  • Lleida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz - PPDS
  • Madrid, Spain, 28049
    • Hospital Clinico San Carlos
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Tarragona, Spain, 43005
    • Hospital Universitari de Tarragona Joan XXIII
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 8907
      • Hospital Universitario de Bellvitge
    • Sabadell, Barcelona, Spain, 8208
      • Corporacio Sanitaria Parc Tauli
    • Terrassa, Barcelona, Spain, 8221
      • Hospital Mútua de Terrassa
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • CHUVI - H.U. Alvaro Cunqueiro
• United Kingdom
  • Bury, United Kingdom, B19 7TD
    • Fairfield General Hospital - PPDS
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary
  • Newcastle, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Aberdeenshire
    • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
      • Aberdeen Royal Infirmary - PPDS
  • Bedfordshire
    • Luton, Bedfordshire, United Kingdom, LU4 0DT
      • Luton and Dunstable Hospital
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG1 5AN
      • Royal Berkshire Hospital NHS Foundation Trust
  • London, City of
    • London, London, City of, United Kingdom, W6 8RF
      • Charing Cross Hospital
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • Northwick Park Hospital
    • London, Middlesex, United Kingdom, E1 1FR
      • The Royal London Hospital
    • London, Middlesex, United Kingdom, WC1N 3BG
      • National Hospital for Neurology & Neurosurgery
  • Surrey
    • London, Surrey, United Kingdom, SE5 9RS
      • King's College Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Banner University of Arizona Medical Center
  • Florida
    • Sarasota, Florida, United States, 34239-3228
      • Intercoastal Medical Group
  • Georgia
    • Augusta, Georgia, United States, 30912-0004
      • Augusta University
  • Illinois
    • Rockford, Illinois, United States, 61114-2300
      • Mercyhealth Javon Bea Hospital- Riverside
  • Indiana
    • Munster, Indiana, United States, 46321-2901
      • Community Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21215-5216
      • Sinai Hospital of Baltimore
  • Michigan
    • Traverse City, Michigan, United States, 49684
      • Munson Healthcare
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic Hospital-Rochester, St. Mary's Campus - PPDS
  • New York
    • Manhasset, New York, United States, 11030-3816
      • North Shore University Hospital-300 Community Dr
    • Poughkeepsie, New York, United States, 12601-3986
      • Nuvance Health Medical Practice, PC- Neurosurgery
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health System - Akron Campus
    • Columbus, Ohio, United States, 43210-1240
      • Ohio State University Wexner Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104-5437
      • Ascension St. John Clinical Research Institute
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center - 3500 Gaston Ave
    • Houston, Texas, United States, 77030-2726
      • Houston Methodist Hospital
    • Plano, Texas, United States, 75093-5338
      • Baylor Scott & White - Plano Brain & Spine Center
    • San Antonio, Texas, United States, 78229-3931
      • University Health-University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Able to initiate study intervention within 25 hours of stroke onset
• Cohort A: Determined by the investigator to not be eligible for systemic thrombolysis and/or mechanical recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy as per local standard of care) for the current stroke.
• Cohort B: Determined by the investigator to be eligible for systemic thrombolysis and/or mechanical recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy as per local standard of care) for the current stroke.
• Cohort A: If a participant is not eligible for systemic thrombolysis and/or mechanical recanalization therapy, screening and baseline NIHSS score of 6 to 22 is required (inclusive) and must be stable, defined as absence of an increase or decrease of ≥4 points within ≥1 hour to ≤3 hours of screening, and NIHSS score should be 6 to 22 at baseline.
• Cohort B: In a participant who is eligible to receive or has received concomitant systemic thrombolysis and/or mechanical recanalization therapy, the NIHSS score must be 6 to 22 at screening prior to systemic thrombolysis and/or mechanical recanalization therapy and the second/baseline NIHSS score must be 6 to 22 and should be done after systemic thrombolysis and/or mechanical recanalization therapy.
• 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.

Key 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 computed tomography or magnetic resonance imaging
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Redasemtide Dose A; Redasemtide will be administered as an intravenous (IV) infusion once daily for 5 consecutive days during hospitalization.	Biological: Redasemtide; Lyophilized white powder reconstituted in 0.9% saline for injection; Other Names: Redasemtide trifluoroacetate; S-005151
Experimental: Redasemtide Dose B; Redasemtide will be administered as an IV infusion once daily for 5 consecutive days during hospitalization.	Biological: Redasemtide; Lyophilized white powder reconstituted in 0.9% saline for injection; Other Names: Redasemtide trifluoroacetate; S-005151
Placebo Comparator: Placebo; Placebo will be administered in an amount equivalent to redasemtide, as an IV infusion, once daily for 5 consecutive days during hospitalization.	Drug: Placebo; Lyophilized white powder reconstituted in 0.9% saline for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Modified Rankin Scale (mRS) Score at Day 90	Day 90

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With mRS Score of 0 to 2	Day 90
Number of Participants With Barthel Index (BI) Score ≥ 95	Day 90
mRS Score at Day 30	Day 30
mRS Score at Day 180	Day 180
Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score of 0 or 1	Days 1, 5, 30, 90, and 180
Change From Baseline in NIHSS Score	Baseline, Days 1, 5, 30, 90, and 180
Change From Day 5 in Short Form 36-item Health Survey (SF-36) Score	Day 5, Days 90 and 180
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
Patient Global Impression of Change Scale (PGI-C) Score	Days 5, 90, and 180
Change From Day 5 in Patient Global Impression of Severity Scale (PGI-S) Score	Day 5, Days 90 and 180
Number of Participants With BI Score ≥ 95	Days 5, 30, and 180

Collaborators and Investigators

• Sponsor: Shionogi

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Thrombectomy; Redasemtide; S-005151; Plasminogen activator
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 2138P2231; 2022-501890-38-00 (Registry Identifier: Clinical Trials Information System (CTIS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No