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

NCT05953480 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2138P22312022-501890-38-00
• Study Type: interventional
• Target: 680
• Locations: 17 countries
• Sites: 150

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

Redasemtide; S-005151; Plasminogen activator; Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS) Score at Day 90

  Day 90

Secondary Outcomes (11)

• 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

Study Arms (3)

Redasemtide Dose A

EXPERIMENTAL

Redasemtide will be administered as an intravenous (IV) infusion once daily for 5 consecutive days during hospitalization.

Biological: Redasemtide

Redasemtide Dose B

EXPERIMENTAL

Redasemtide will be administered as an IV infusion once daily for 5 consecutive days during hospitalization.

Biological: Redasemtide

Placebo

PLACEBO COMPARATOR

Placebo will be administered in an amount equivalent to redasemtide, as an IV infusion, once daily for 5 consecutive days during hospitalization.

Drug: Placebo

Interventions

Redasemtide BIOLOGICAL

Lyophilized white powder reconstituted in 0.9% saline for injection

Also known as: Redasemtide trifluoroacetate, S-005151

Redasemtide Dose A; Redasemtide Dose B

Placebo DRUG

Lyophilized white powder reconstituted in 0.9% saline for injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shionogi: lead

Study Sites (150)

Banner University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Intercoastal Medical Group

Sarasota, Florida, 34239-3228, United States

Location

Augusta University

Augusta, Georgia, 30912-0004, United States

Location

Mercyhealth Javon Bea Hospital- Riverside

Rockford, Illinois, 61114-2300, United States

Location

Community Hospital

Munster, Indiana, 46321-2901, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215-5216, United States

Location

Munson Healthcare

Traverse City, Michigan, 49684, United States

Location

Mayo Clinic Hospital-Rochester, St. Mary's Campus - PPDS

Rochester, Minnesota, 55905-0001, United States

Location

North Shore University Hospital-300 Community Dr

Manhasset, New York, 11030-3816, United States

Location

Nuvance Health Medical Practice, PC- Neurosurgery

Poughkeepsie, New York, 12601-3986, United States

Location

Summa Health System - Akron Campus

Akron, Ohio, 44304, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210-1240, United States

Location

Ascension St. John Clinical Research Institute

Tulsa, Oklahoma, 74104-5437, United States

Location

Baylor University Medical Center - 3500 Gaston Ave

Dallas, Texas, 75246, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030-2726, United States

Location

Baylor Scott & White - Plano Brain & Spine Center

Plano, Texas, 75093-5338, United States

Location

University Health-University Hospital

San Antonio, Texas, 78229-3931, United States

Location

Liverpool Hospital - PPDS

Sydney, New South Wales, 2170, Australia

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3052, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

UZ Brussel - PIN

Jette, Brussels Capital, 1090, Belgium

Location

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

AZ Oostende - Damiaan

Ostend, West-Vlaanderen, 8400, Belgium

Location

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Beijing Luhe Hospital, Capital Medical University

Beijing, Beijing Municipality, 101199, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210001, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2

Prague, Nové Město, 101 00, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, Praha, Hlavní Mesto, 100 00, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

Helsingin yliopistollinen sairaala

Helsinki, Uusimaa, 290, Finland

Location

Universitatsklinikum Leipzig

Leipzig, Saxony, 4103, Germany

Location

Klinikum Altenburger Land GmbH

Altenburg, Thuringia, 4600, Germany

Location

University General Hospital of Patras

Pátrai, Achaïa, 265 04, Greece

Location

Naval Hospital of Athens

Athens, Attica, 115 21, Greece

Location

Alexandra Hospital

Athens, Attica, 11528, Greece

Location

University General Hospital of Alexandroupolis

Alexandroupoli, Evros, 681 00, Greece

Location

University General Hospital of Heraklion

Heraklion, Irakleio, 710 03, Greece

Location

University General Hospital ''ATTIKON''

Athens, 12462, Greece

Location

University General Hospital of Ioannina

Ioannina, 455 00, Greece

Location

University General Hospital of Larissa

Larissa, 411 10, Greece

Location

AHEPA University General Hospital of Thessaloniki

Thessaloniki, 546 36, Greece

Location

General Hospital of Thessaloniki ''Hippokratio''

Thessaloniki, 546 42, Greece

Location

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, 56429, Greece

Location

General Hospital of Thessaloniki ''G. Papanikolaou''

Thessaloniki, 570 10, Greece

Location

Queen Mary Hospital - PPDS

Hong Kong, 999077, Hong Kong

Location

Princess Margaret Hospital - Hong Kong

Kwai Chung, 999077, Hong Kong

Location

Prince of Wales Hospital

Shatin, 999077, Hong Kong

Location

Pécsi Tudomanyegyetem - Vasvari Pal u.

Pécs, Baranya, 7624, Hungary

Location

Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz és Egyetemi Oktatokorhaz

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

Location

Kistarcsai Flór Ferenc Kórház

Kistarcsa, Pest County, 2143, Hungary

Location

Szent Damjan Gorogkatolikus Korhaz

Kisvárda, Szabolcs-Szatmár-Bereg, 4600, Hungary

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, 1106, Hungary

Location

Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika

Budapest, 1145, Hungary

Location

Gyor-Moson-Sopron Varmegyei Petz Aladár Egyetemi Oktató Kórház

Győr, 9024, Hungary

Location

Meir Medical Center

Kfar Saba, Central District, 44281, Israel

Location

Hillel Yaffe Medical Center

Hadera, Haifa District, 38100, Israel

Location

Hadassah Medical Center - PPDS

Jerusalem, Jerusalem, 91120, Israel

Location

Galilee Medical Center

Nahariya, Northern District, 2210000, Israel

Location

Tel Aviv Sourasky Medical Center - PPDS

Tel Aviv, Tel Aviv, 64239, Israel

Location

Barzilai Medical Center

Ashkelon, 7830604, Israel

Location

Rambam Medical Center - PPDS

Haifa, 31096, Israel

Location

Sheba Medical Center - PPDS

Ramat Gan, 5262000, Israel

Location

ZIV Medical Center

Safed, 13100, Israel

Location

National Hospital Organization Toyohashi Medical Center

Toyohashi, Aichi-ken, 440-8510, Japan

Location

Kimitsu Chuo Hospital

Kisarazu, Chiba, 292-8535, Japan

Location

Social Medical Corporation The Chiyukai Foundation Fukuoka Wajiro Hospital

Fukuoka, Fukuoka, 811-0213, Japan

Location

Shin Komonji Hospital

Kitakyushu-Shi, Fukuoka, 800-0057, Japan

Location

Omuta City Hospital

Omuta-Shi, Fukuoka, 836-8567, Japan

Location

Japanese Red Cross Takayama Hospital

Takayama-Shi, Gifu, 506-8550, Japan

Location

National Hospital Organization Higashihiroshima Medical Center

Higashihiroshima-Shi, Hiroshima, 739-0041, Japan

Location

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Kure-Shi, Hiroshima, 737-0023, Japan

Location

Fukui Prefectural Hospital

Fukui-shi, Hukui, 910-8526, Japan

Location

Our Lady of the Snow Social Medical Corporation St. Mary's Hospital

Kurume-Shi, Hukuoka, 830-8543, Japan

Location

Shinsuma General Hospital

Kobe, Hyôgo, 654-0048, Japan

Location

Hyogo Medical University Hospital

Nishinomiya-Shi, Hyôgo, 663-8501, Japan

Location

Seisho Hospital

Odawara-Shi, Kanagawa, 250-0001, Japan

Location

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, 245-8575, Japan

Location

National Hospital Organization Beppu Medical Center

Beppu-Shi, Oita Prefecture, 874-0011, Japan

Location

Rinku General Medical Center

Izumisano, Osaka, 598-8577, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, Osaka, 540-0006, Japan

Location

Tominaga Hospital

Osaka, Osaka, 556-0017, Japan

Location

National Cerebral and Cardiovascular Center

Suita-Shi, Osaka, 564-8565, Japan

Location

Osaka University Hospital

Suita-Shi, Osaka, 565-0871, Japan

Location

Shin-Kuki General Hospital

Kuki-shi, Saitama, 346-8530, Japan

Location

National Hospital Organization Hamada Medical Center

Hamada-Shi, Shimane, 697-8511, Japan

Location

Shizuoka City Shizuoka Hospital

Aoi-Ku, Shizuoka, 420-8630, Japan

Location

Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital

Hamamatsu, Shizuoka, 430-8525, Japan

Location

Chutoen General Medical Center

Kakegawa-Shi, Shizuoka, 436-8555, Japan

Location

Misyuku Hospital

Meguro-Ku, Tokyo, 153-0051, Japan

Location

Sanyudo Hospital

Yonezawa-Shi, Yamagata, 992-0033, Japan

Location

Hospital for Cerebrovascular Diseases Sveti Sava

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

University Clinical Center of Serbia - Pasterova 2 - PPDS

Belgrade, 11000, Serbia

Location

General Hospital Bor

Bor, 19210, Serbia

Location

General Hospital Cuprija

Ćuprija, 35230, Serbia

Location

General Hospital Leskovac

Leskovac, 16000, Serbia

Location

University Clinical Center Nis

Niš, 18 000, Serbia

Location

Clinical Centre of Vojvodina

Novi Sad, 21000, Serbia

Location

Health Center Uzice

Užice, 31000, Serbia

Location

Health Center Valjevo

Valjevo, 250804, Serbia

Location

General Hospital Dr. Djordje Joanovic - Zrenjanin

Zrenjanin, 23000, Serbia

Location

National University Hospital- Singapore

Singapore, 119074, Singapore

Location

Singapore General Hospital (SGH)

Singapore, 169608, Singapore

Location

Keimyung University Dongsan Hospital

Daegu, Daegu Gwang'yeogsi, 42601, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggido, 10380, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Kyung Hee University Hospital

Seoul, 2447, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 3722, South Korea

Location

Hanyang University Medical Center

Seoul, 4763, South Korea

Location

Samsung Medical Center

Seoul, 6351, South Korea

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 8907, Spain

Location

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, 8208, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Barcelona, 8221, Spain

Location

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

Hospital Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Universitario Torrecardenas

Almería, 4009, Spain

Location

Hospital Universitario de Badajoz

Badajoz, 6006, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 8025, Spain

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 8035, Spain

Location

Hospital Universitario Virgen de La Arrixaca

El Palmar, 30120, Spain

Location

Hospital Universitari de Girona Dr Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz - PPDS

Madrid, 28046, Spain

Location

Hospital Clinico San Carlos

Madrid, 28049, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitari de Tarragona Joan XXIII

Tarragona, 43005, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Aberdeen Royal Infirmary - PPDS

Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom

Location

Luton and Dunstable Hospital

Luton, Bedfordshire, LU4 0DT, United Kingdom

Location

Royal Berkshire Hospital NHS Foundation Trust

Reading, Berkshire, RG1 5AN, United Kingdom

Location

Charing Cross Hospital

London, London, City of, W6 8RF, United Kingdom

Location

Northwick Park Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

The Royal London Hospital

London, Middlesex, E1 1FR, United Kingdom

Location

National Hospital for Neurology & Neurosurgery

London, Middlesex, WC1N 3BG, United Kingdom

Location

King's College Hospital

London, Surrey, SE5 9RS, United Kingdom

Location

Fairfield General Hospital - PPDS

Bury, B19 7TD, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Royal Victoria Infirmary

Newcastle, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: July 14, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); KR (7); HU (8); GB (11); HK (3); IL (9); DE (2); GR (12); ES (22); SE (11); BE (3); AU (6); JP (27); SG (2); US (17); CN (6); CZ (3)