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Acute Ischemic StrokePhase 2ReviveNCT05953480

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

A Phase 2 study testing Redasemtide in people with Acute Ischemic Stroke, run by Shionogi at 150 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Redasemtide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
680 participants
Where
150 sitesin 17 countries
Study dates
14 Jul 2023to 15 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

150 sites in 17 countries.

150 sites in 17 countries

Japan27 sites

  • Shizuoka City Shizuoka Hospital

    Aoi-Ku, Shizuoka, 420-8630

  • National Hospital Organization Beppu Medical Center

    Beppu-Shi, Oita Prefecture, 874-0011

  • Fukui Prefectural Hospital

    Fukui-shi, Hukui, 910-8526

  • Social Medical Corporation The Chiyukai Foundation Fukuoka Wajiro Hospital

    Fukuoka, Fukuoka, 811-0213

  • National Hospital Organization Hamada Medical Center

    Hamada-Shi, Shimane, 697-8511

  • Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital

    Hamamatsu, Shizuoka, 430-8525

  • National Hospital Organization Higashihiroshima Medical Center

    Higashihiroshima-Shi, Hiroshima, 739-0041

  • Rinku General Medical Center

    Izumisano, Osaka, 598-8577

  • Chutoen General Medical Center

    Kakegawa-Shi, Shizuoka, 436-8555

  • Kimitsu Chuo Hospital

    Kisarazu, Chiba, 292-8535

  • Shin Komonji Hospital

    Kitakyushu-Shi, Fukuoka, 800-0057

  • Shinsuma General Hospital

    Kobe, Hyôgo, 654-0048

  • Shin-Kuki General Hospital

    Kuki-shi, Saitama, 346-8530

  • National Hospital Organization Kure Medical Center and Chugoku Cancer Center

    Kure-Shi, Hiroshima, 737-0023

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

    Kurume-Shi, Hukuoka, 830-8543

  • Misyuku Hospital

    Meguro-Ku, Tokyo, 153-0051

  • Hyogo Medical University Hospital

    Nishinomiya-Shi, Hyôgo, 663-8501

  • Seisho Hospital

    Odawara-Shi, Kanagawa, 250-0001

  • Omuta City Hospital

    Omuta-Shi, Fukuoka, 836-8567

  • National Hospital Organization Osaka National Hospital

    Osaka, Osaka, 540-0006

  • Tominaga Hospital

    Osaka, Osaka, 556-0017

  • National Cerebral and Cardiovascular Center

    Suita-Shi, Osaka, 564-8565

  • Osaka University Hospital

    Suita-Shi, Osaka, 565-0871

  • Japanese Red Cross Takayama Hospital

    Takayama-Shi, Gifu, 506-8550

  • National Hospital Organization Toyohashi Medical Center

    Toyohashi, Aichi-ken, 440-8510

  • National Hospital Organization Yokohama Medical Center

    Yokohama, Kanagawa, 245-8575

  • Sanyudo Hospital

    Yonezawa-Shi, Yamagata, 992-0033

Other trials in Japan

Spain22 sites

  • Hospital Universitario A Coruña

    A Coruña, 15006

  • Hospital Universitario Torrecardenas

    Almería, 4009

  • Hospital Universitario de Badajoz

    Badajoz, 6006

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 8025

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, 30120

  • Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 8907

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Clinico San Carlos

    Madrid, 28049

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 8208

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitari de Tarragona Joan XXIII

    Tarragona, 43005

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 8221

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

United States17 sites

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Augusta University

    Augusta, Georgia, 30912-0004

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215-5216

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210-1240

  • Baylor University Medical Center - 3500 Gaston Ave

    Dallas, Texas, 75246

  • Houston Methodist Hospital

    Houston, Texas, 77030-2726

  • North Shore University Hospital-300 Community Dr

    Manhasset, New York, 11030-3816

  • Community Hospital

    Munster, Indiana, 46321-2901

  • Baylor Scott & White - Plano Brain & Spine Center

    Plano, Texas, 75093-5338

  • Nuvance Health Medical Practice, PC- Neurosurgery

    Poughkeepsie, New York, 12601-3986

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

    Rochester, Minnesota, 55905-0001

  • Mercyhealth Javon Bea Hospital- Riverside

    Rockford, Illinois, 61114-2300

  • University Health-University Hospital

    San Antonio, Texas, 78229-3931

  • Intercoastal Medical Group

    Sarasota, Florida, 34239-3228

  • Munson Healthcare

    Traverse City, Michigan, 49684

  • Banner University of Arizona Medical Center

    Tucson, Arizona, 85724

  • Ascension St. John Clinical Research Institute

    Tulsa, Oklahoma, 74104-5437

Other trials in United States

Greece12 sites

  • University General Hospital of Alexandroupolis

    Alexandroupoli, Evros, 681 00

  • Naval Hospital of Athens

    Athens, Attica, 115 21

  • Alexandra Hospital

    Athens, Attica, 11528

  • University General Hospital ''ATTIKON''

    Athens, 12462

  • University General Hospital of Heraklion

    Heraklion, Irakleio, 710 03

  • University General Hospital of Ioannina

    Ioannina, 455 00

  • University General Hospital of Larissa

    Larissa, 411 10

  • University General Hospital of Patras

    Pátrai, Achaïa, 265 04

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki, 546 36

  • General Hospital of Thessaloniki ''Hippokratio''

    Thessaloniki, 546 42

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 56429

  • General Hospital of Thessaloniki ''G. Papanikolaou''

    Thessaloniki, 570 10

Other trials in Greece

Serbia11 sites

  • Hospital for Cerebrovascular Diseases Sveti Sava

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • University Clinical Center of Serbia - Pasterova 2 - PPDS

    Belgrade, 11000

  • General Hospital Bor

    Bor, 19210

  • General Hospital Cuprija

    Ćuprija, 35230

  • General Hospital Leskovac

    Leskovac, 16000

  • University Clinical Center Nis

    Niš, 18 000

  • Clinical Centre of Vojvodina

    Novi Sad, 21000

  • Health Center Uzice

    Užice, 31000

  • Health Center Valjevo

    Valjevo, 250804

  • General Hospital Dr. Djordje Joanovic - Zrenjanin

    Zrenjanin, 23000

Other trials in Serbia

United Kingdom11 sites

  • Aberdeen Royal Infirmary - PPDS

    Aberdeen, Aberdeenshire, AB25 2ZD

  • Fairfield General Hospital - PPDS

    Bury, B19 7TD

  • Northwick Park Hospital

    Harrow, Middlesex, HA1 3UJ

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Charing Cross Hospital

    London, London, City of, W6 8RF

  • The Royal London Hospital

    London, Middlesex, E1 1FR

  • National Hospital for Neurology & Neurosurgery

    London, Middlesex, WC1N 3BG

  • King's College Hospital

    London, Surrey, SE5 9RS

  • Luton and Dunstable Hospital

    Luton, Bedfordshire, LU4 0DT

  • Royal Victoria Infirmary

    Newcastle, NE1 4LP

  • Royal Berkshire Hospital NHS Foundation Trust

    Reading, Berkshire, RG1 5AN

Other trials in United Kingdom

Israel9 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Hillel Yaffe Medical Center

    Hadera, Haifa District, 38100

  • Rambam Medical Center - PPDS

    Haifa, 31096

  • Hadassah Medical Center - PPDS

    Jerusalem, Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, Central District, 44281

  • Galilee Medical Center

    Nahariya, Northern District, 2210000

  • Sheba Medical Center - PPDS

    Ramat Gan, 5262000

  • ZIV Medical Center

    Safed, 13100

  • Tel Aviv Sourasky Medical Center - PPDS

    Tel Aviv, Tel Aviv, 64239

Other trials in Israel

Hungary8 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106

  • Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika

    Budapest, 1145

  • Gyor-Moson-Sopron Varmegyei Petz Aladár Egyetemi Oktató Kórház

    Győr, 9024

  • Kistarcsai Flór Ferenc Kórház

    Kistarcsa, Pest County, 2143

  • Szent Damjan Gorogkatolikus Korhaz

    Kisvárda, Szabolcs-Szatmár-Bereg, 4600

  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz és Egyetemi Oktatokorhaz

    Miskolc, Borsod-Abauj Zemplen county, 3526

  • Pécsi Tudomanyegyetem - Vasvari Pal u.

    Pécs, Baranya, 7624

Other trials in Hungary

South Korea7 sites

  • Pusan National University Hospital

    Busan, 49241

  • Keimyung University Dongsan Hospital

    Daegu, Daegu Gwang'yeogsi, 42601

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggido, 10380

  • Kyung Hee University Hospital

    Seoul, 2447

  • Severance Hospital Yonsei University Health System

    Seoul, 3722

  • Hanyang University Medical Center

    Seoul, 4763

  • Samsung Medical Center

    Seoul, 6351

Other trials in South Korea

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Royal Melbourne Hospital

    Parkville, Victoria, 3052

  • Gold Coast University Hospital

    Southport, Queensland, 4215

  • Liverpool Hospital - PPDS

    Sydney, New South Wales, 2170

Other trials in Australia

China6 sites

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101199

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102218

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210001

Other trials in China

Belgium3 sites

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • UZ Brussel - PIN

    Jette, Brussels Capital, 1090

  • AZ Oostende - Damiaan

    Ostend, West-Vlaanderen, 8400

Other trials in Belgium

Czechia3 sites

  • Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2

    Prague, Nové Město, 101 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Praha, Hlavní Mesto, 100 00

  • Fakultni nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

Hong Kong3 sites

  • Queen Mary Hospital - PPDS

    Hong Kong, 999077

  • Princess Margaret Hospital - Hong Kong

    Kwai Chung, 999077

  • Prince of Wales Hospital

    Shatin, 999077

Other trials in Hong Kong

Germany2 sites

  • Klinikum Altenburger Land GmbH

    Altenburg, Thuringia, 4600

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 4103

Other trials in Germany

Singapore2 sites

  • National University Hospital- Singapore

    Singapore, 119074

  • Singapore General Hospital (SGH)

    Singapore, 169608

Other trials in Singapore

Finland1 site

  • Helsingin yliopistollinen sairaala

    Helsinki, Uusimaa, 290

Other trials in Finland

About this study

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

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.

Being tested
Redasemtide, Placebo
Keywords
Redasemtide, S-005151, Plasminogen activator, Thrombectomy
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RedasemtideBiological

    Also called Redasemtide trifluoroacetate, S-005151

    Lyophilized white powder reconstituted in 0.9% saline for injection

  • PlaceboDrug

    Lyophilized white powder reconstituted in 0.9% saline for injection

Study groups in NCT05953480
Study groupRoleWhat they receive
Redasemtide Dose AExperimentalRedasemtide will be administered as an intravenous (IV) infusion once daily for 5 consecutive days during hospitalization.
Receives: Biological: Redasemtide
Redasemtide Dose BExperimentalRedasemtide will be administered as an IV infusion once daily for 5 consecutive days during hospitalization.
Receives: Biological: Redasemtide
PlaceboPlacebo comparatorPlacebo will be administered in an amount equivalent to redasemtide, as an IV infusion, once daily for 5 consecutive days during hospitalization.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Rankin Scale (mRS) Score at Day 90

    Measured: Day 90

Secondary outcomes (11)

  1. Number of Participants With mRS Score of 0 to 2

    Measured: Day 90

  2. Number of Participants With Barthel Index (BI) Score ≥ 95

    Measured: Day 90

  3. mRS Score at Day 30

    Measured: Day 30

  4. mRS Score at Day 180

    Measured: Day 180

  5. Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score of 0 or 1

    Measured: Days 1, 5, 30, 90, and 180

  6. Change From Baseline in NIHSS Score

    Measured: Baseline, Days 1, 5, 30, 90, and 180

  7. Number of Participants With BI Score ≥ 95

    Measured: Days 5, 30, and 180

  8. Change From Day 5 in Short Form 36-item Health Survey (SF-36) Score

    Measured: Day 5, Days 90 and 180

  9. Change From Day 5 in Stroke and Aphasia Quality of Life Scale - 39 Item Generic Version (SAQoL-39g) Score

    Measured: Day 5, Days 90 and 180

  10. Patient Global Impression of Change Scale (PGI-C) Score

    Measured: Days 5, 90, and 180

  11. Change From Day 5 in Patient Global Impression of Severity Scale (PGI-S) Score

    Measured: Day 5, Days 90 and 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2023
  2. Study start14 Jul 2023
  3. Primary completion15 Jun 2026
  4. Study completion15 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
680 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05953480
Sponsor's protocol ID
2138P2231
Other IDs
2022-501890-38-00
Acronym
Revive
Status last verified
Jul 2026
First submitted
12 Jul 2023
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Redasemtide in people with Acute Ischemic Stroke, run by Shionogi at 150 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in Japan, Spain, United States, Greece, Serbia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale (mRS) Score at Day 90 (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05953480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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