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ACTIVE NOT RECRUITING
NCT05953480
PHASE2

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

Sponsor: Shionogi

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

680

Start Date

2023-07-14

Completion Date

2026-03-31

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

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 (150)

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

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 Oostende - Damiaan

Ostend, West-Vlaanderen, 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 Kralovske Vinohrady

Prague, Praha, Hlavní Mesto, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

Helsingin yliopistollinen sairaala

Helsinki, Uusimaa, Finland

Universitatsklinikum Leipzig

Leipzig, Saxony, Germany

Klinikum Altenburger Land GmbH

Altenburg, Thuringia, 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

Kistarcsai Flór Ferenc Kórház

Kistarcsa, Pest County, Hungary

Szent Damjan Gorogkatolikus Korhaz

Kisvárda, Szabolcs-Szatmár-Bereg, Hungary

Semmelweis Egyetem

Budapest, Hungary

Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, Hungary

Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika

Budapest, Hungary

Gyor-Moson-Sopron Varmegyei Petz Aladár Egyetemi Oktató Kórház

Győr, Hungary

Meir Medical Center

Kfar Saba, Central District, Israel

Hillel Yaffe Medical Center

Hadera, Haifa District, Israel

Hadassah Medical Center - PPDS

Jerusalem, Jerusalem, Israel

Galilee Medical Center

Nahariya, Northern 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

National Hospital Organization Higashihiroshima Medical Center

Higashihiroshima-Shi, Hiroshima, Japan

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Kure-Shi, Hiroshima, 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

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

Sanyudo Hospital

Yonezawa-Shi, Yamagata, 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

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