A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke
NCT ID: NCT05953480
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
849 participants
INTERVENTIONAL
2023-07-14
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Redasemtide Dose A
Redasemtide will be administered as an intravenous (IV) infusion once daily for 5 consecutive days during hospitalization.
Redasemtide
Lyophilized white powder reconstituted in 0.9% saline for injection
Redasemtide Dose B
Redasemtide will be administered as an IV infusion once daily for 5 consecutive days during hospitalization.
Redasemtide
Lyophilized white powder reconstituted in 0.9% saline for injection
Placebo
Placebo will be administered in an amount equivalent to redasemtide, as an IV infusion, once daily for 5 consecutive days during hospitalization.
Placebo
Lyophilized white powder reconstituted in 0.9% saline for injection
Interventions
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Redasemtide
Lyophilized white powder reconstituted in 0.9% saline for injection
Placebo
Lyophilized white powder reconstituted in 0.9% saline for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Shionogi
INDUSTRY
Responsible Party
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Locations
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Banner University of Arizona Medical Center
Tucson, Arizona, United States
Intercoastal Medical Group
Sarasota, Florida, United States
Augusta University
Augusta, Georgia, United States
Mercyhealth Javon Bea Hospital- Riverside
Rockford, Illinois, United States
Community Hospital
Munster, Indiana, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Munson Healthcare
Traverse City, Michigan, United States
Mayo Clinic Hospital-Rochester, St. Mary's Campus - PPDS
Rochester, Minnesota, United States
North Shore University Hospital-300 Community Dr
Manhasset, New York, United States
Nuvance Health Medical Practice, PC- Neurosurgery
Poughkeepsie, New York, United States
Summa Health System - Akron Campus
Akron, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Ascension St. John Clinical Research Institute
Tulsa, Oklahoma, United States
Baylor University Medical Center - 3500 Gaston Ave
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Baylor Scott & White - Plano Brain & Spine Center
Plano, Texas, United States
University Health-University Hospital
San Antonio, Texas, United States
Liverpool Hospital - PPDS
Sydney, New South Wales, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
UZ Brussel - PIN
Jette, Brussels Capital, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
AZ Sint-Jan Brugge AV
Bruges, West-Vlaanderen, Belgium
AZ Oostende - Damiaan
Ostend, West-Vlaanderen, Belgium
UZ Leuven
Leuven, , Belgium
Clinique CHC MontLégia
Liège, , Belgium
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2
Prague, Nové Město, Czechia
Fakultni Nemocnice Olomouc
Olomouc, Olomoucký kraj, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha, Hlavní Mesto, Czechia
Nemocnice AGEL Ostrava-Vitkovice a.s.
Ostrava - Vitkovice, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Regionshospitalet Gødstrup
Herning, Central Jutland, Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, Zeeland, Denmark
Helsingin yliopistollinen sairaala
Helsinki, Uusimaa, Finland
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Varisano - Klinikum Frankfurt Höchst GmbH
Frankfurt am Main, Hesse, Germany
UKGM - Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen
Giessen, Hesse, Germany
Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, Germany
Städtisches Klinikum Dresden -Friedrichstadt
Dresden, Saxony, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, Germany
Klinikum Altenburger Land GmbH
Altenburg, Thuringia, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, , Germany
University General Hospital of Patras
Pátrai, Achaïa, Greece
Naval Hospital of Athens
Athens, Attica, Greece
Alexandra Hospital
Athens, Attica, Greece
University General Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece
University General Hospital of Heraklion
Heraklion, Irakleio, Greece
University General Hospital ''ATTIKON''
Athens, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
University General Hospital of Larissa
Larissa, , Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, , Greece
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, , Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, , Greece
General Hospital of Thessaloniki ''G. Papanikolaou''
Thessaloniki, , Greece
Queen Mary Hospital - PPDS
Hong Kong, , Hong Kong
Princess Margaret Hospital - Hong Kong
Kwai Chung, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
Pécsi Tudomanyegyetem - Vasvari Pal u.
Pécs, Baranya, Hungary
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz és Egyetemi Oktatokorhaz
Miskolc, Borsod-Abauj Zemplen county, Hungary
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen, Hajdú-Bihar, Hungary
Kistarcsai Flór Ferenc Kórház
Kistarcsa, Pest County, Hungary
Váci Jávorszky Ödön Kórház
Vác, Pest County, Hungary
Szent Damjan Gorogkatolikus Korhaz
Kisvárda, Szabolcs-Szatmár-Bereg, Hungary
Semmelweis Egyetem
Budapest, , Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, , Hungary
Eszak-Pesti Centrumkorhaz -Honvedkorhaz
Budapest, , Hungary
Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika
Budapest, , Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladár Egyetemi Oktató Kórház
Győr, , Hungary
Veszprém Vármegyei Csolnoky Ferenc Kórház
Veszprém, , Hungary
Meir Medical Center
Kfar Saba, Central District, Israel
Hillel Yaffe Medical Center
Hadera, Haifa District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Hadassah Medical Center - PPDS
Jerusalem, Jerusalem, Israel
Galilee Medical Center
Nahariya, Northern District, Israel
Assuta Ashdod Medical Center
Ashdod, Southern District, Israel
Tel Aviv Sourasky Medical Center - PPDS
Tel Aviv, Tel Aviv, Israel
Barzilai Medical Center
Ashkelon, , Israel
Rambam Medical Center - PPDS
Haifa, , Israel
Sheba Medical Center - PPDS
Ramat Gan, , Israel
ZIV Medical Center
Safed, , Israel
National Hospital Organization Toyohashi Medical Center
Toyohashi, Aichi-ken, Japan
Kimitsu Chuo Hospital
Kisarazu, Chiba, Japan
Social Medical Corporation The Chiyukai Foundation Fukuoka Wajiro Hospital
Fukuoka, Fukuoka, Japan
Shin Komonji Hospital
Kitakyushu-Shi, Fukuoka, Japan
Omuta City Hospital
Omuta-Shi, Fukuoka, Japan
Japanese Red Cross Takayama Hospital
Takayama-Shi, Gifu, Japan
Mazda Hospital of Mazda Motor Corporation
Aki-gun, Hiroshima, Japan
National Hospital Organization Higashihiroshima Medical Center
Higashihiroshima-Shi, Hiroshima, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Kure-Shi, Hiroshima, Japan
Social Medical Corporation Hakuyoukai Kashiwaba Neurosurgical Hospital
Sapporo, Hokkaido, Japan
Fukui Prefectural Hospital
Fukui-shi, Hukui, Japan
Our Lady of the Snow Social Medical Corporation St. Mary's Hospital
Kurume-Shi, Hukuoka, Japan
Shinsuma General Hospital
Kobe, Hyôgo, Japan
Hyogo Medical University Hospital
Nishinomiya-Shi, Hyôgo, Japan
JA Toride Medical Center
Toride-Shi, Ibaraki, Japan
Tsukuba Medical Center Hospital
Tsukuba, Ibaraki, Japan
Seisho Hospital
Odawara-Shi, Kanagawa, Japan
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, Japan
National Hospital Organization Beppu Medical Center
Beppu-Shi, Oita Prefecture, Japan
Rinku General Medical Center
Izumisano, Osaka, Japan
National Hospital Organization Osaka National Hospital
Osaka, Osaka, Japan
Tominaga Hospital
Osaka, Osaka, Japan
National Cerebral and Cardiovascular Center
Suita-Shi, Osaka, Japan
Osaka University Hospital
Suita-Shi, Osaka, Japan
Shin-Kuki General Hospital
Kuki-shi, Saitama, Japan
National Hospital Organization Hamada Medical Center
Hamada-Shi, Shimane, Japan
Shizuoka City Shizuoka Hospital
Aoi-Ku, Shizuoka, Japan
Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital
Hamamatsu, Shizuoka, Japan
Chutoen General Medical Center
Kakegawa-Shi, Shizuoka, Japan
Misyuku Hospital
Meguro-Ku, Tokyo, Japan
Ome Medical Center
Ome-Shi, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku, Tokyo, Japan
Sanyudo Hospital
Yonezawa-Shi, Yamagata, Japan
Sainokuni Higashiomiya Medical Center
Saitama, , Japan
Hospital for Cerebrovascular Diseases Sveti Sava
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
University Clinical Center of Serbia - Pasterova 2 - PPDS
Belgrade, , Serbia
General Hospital Bor
Bor, , Serbia
General Hospital Cuprija
Ćuprija, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
General Hospital Leskovac
Leskovac, , Serbia
University Clinical Center Nis
Niš, , Serbia
Clinical Centre of Vojvodina
Novi Sad, , Serbia
Health Center Uzice
Užice, , Serbia
Health Center Valjevo
Valjevo, , Serbia
General Hospital Dr. Djordje Joanovic - Zrenjanin
Zrenjanin, , Serbia
National University Hospital- Singapore
Singapore, , Singapore
Singapore General Hospital (SGH)
Singapore, , Singapore
Keimyung University Dongsan Hospital
Daegu, Daegu Gwang'yeogsi, South Korea
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggido, South Korea
Pusan National University Hospital
Busan, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Hanyang University Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitario A Coruña
A Coruña, , Spain
Hospital Universitario Torrecardenas
Almería, , Spain
Hospital Universitario de Badajoz
Badajoz, , Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar, , Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona, , Spain
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz - PPDS
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitari de Tarragona Joan XXIII
Tarragona, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Aberdeen Royal Infirmary - PPDS
Aberdeen, Aberdeenshire, United Kingdom
Luton and Dunstable Hospital
Luton, Bedfordshire, United Kingdom
Royal Berkshire Hospital NHS Foundation Trust
Reading, Berkshire, United Kingdom
Charing Cross Hospital
London, London, City of, United Kingdom
Northwick Park Hospital
Harrow, Middlesex, United Kingdom
The Royal London Hospital
London, Middlesex, United Kingdom
National Hospital for Neurology & Neurosurgery
London, Middlesex, United Kingdom
King's College Hospital
London, Surrey, United Kingdom
Fairfield General Hospital - PPDS
Bury, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Royal Victoria Infirmary
Newcastle, , United Kingdom
Countries
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Central Contacts
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Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: CONTACT
Other Identifiers
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2022-501890-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2138P2231
Identifier Type: -
Identifier Source: org_study_id
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