Clinical trial NCT05953480: A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke
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 Who Are Not Eligible for Tissue Pasminogen Activator or Thrombectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Keywords: Redasemtide
S-005151
Plasminogen activator
Thrombectomy
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS).


Eligibility criteria: Inclusion Criteria:

* Able to initiate study intervention within 25 hours of stroke onset
* Determined by the investigator to not be eligible for recanalization thrombolysis or endovascular recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy) for the current stroke.
* Baseline NIHSS score of 8 to 22 (inclusive) and stable, defined as absence of an increase or decrease of ≥ 4 points within ≥ 1 hour to ≤ 3 hours between screening and baseline assessment of NIHSS score.
* 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:

* 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 CT or MRI
* 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.

Primary outcomes:
measure: Modified Rankin Scale (mRS) Score at Day 90
timeFrame: Day 90
Secondary outcomes:
measure: Number of Participants With mRS Score of 0 to 2
timeFrame: Day 90
measure: Number of Participants With Barthel Index (BI) Score ≥ 95
timeFrame: Day 90
measure: mRS Score at Day 30
timeFrame: Day 30
measure: mRS Score at Day 180
timeFrame: Day 180
measure: Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score of 0 or 1
timeFrame: Days 1, 5, 30, 90, and 180
measure: Change From Baseline in NIHSS Score
timeFrame: Baseline, Days 1, 5, 30, 90, and 180
measure: Number of Participants With BI Score ≥ 95
timeFrame: Days 5, 30, 90, and 180
measure: Change From Day 5 in Short Form 36-item Health Survey (SF-36) Score
timeFrame: Day 5, Days 90 and 180
measure: Change From Day 5 in Stroke and Aphasia Quality of Life Scale - 39 Item Generic Version (SAQoL-39g) Score
timeFrame: Day 5, Days 90 and 180
measure: Patient Global Impression of Change Scale (PGI-C) Score
timeFrame: Days 5, 90, and 180
measure: Change From Day 5 in Patient Global Impression of Severity Scale (PGI-S) Score
timeFrame: Day 5, Days 90 and 180
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University of Arizona Medical Center
state: Arizona
city: Sarasota
country: United States
facility: Intercoastal Medical Group
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Rockford
country: United States
facility: Mercyhealth Javon Bea Hospital- Riverside
state: Illinois
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Traverse City
country: United States
facility: Munson Healthcare
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Hospital-Rochester, St. Marys Campus - PPDS
state: Minnesota
city: Great Neck
country: United States
facility: Nuvance Health Medical Practice, PC- Neurosurgery
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital-300 Community Dr
state: New York
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Ascension St. John Clinical Research Institute
state: Oklahoma
city: Dallas
country: United States
facility: Baylor University Medical Center - 3500 Gaston Ave
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White - Plano Brain & Spine Center
state: Texas
city: San Antonio
country: United States
facility: University Health-University Hospital
state: Texas
city: Sydney
country: Australia
facility: Liverpool Hospital - PPDS
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Health, Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Jette
country: Belgium
facility: UZ Brussel - PIN
state: Brussels
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge AV
state: West-Vlaanderen
city: Oostende
country: Belgium
facility: AZ Oostende - Damiaan
state: West-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: Clinique CHC MontLégia
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc
state: Olomoucký Kraj
city: Praha
country: Czechia
facility: Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2
state: Praha, Hlavní Mesto
city: Ostrava - Vitkovice
country: Czechia
facility: Nemocnice AGEL Ostrava-Vitkovice a.s.
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole
city: Herning
country: Denmark
facility: Regionshospitalet Gødstrup
state: Central Jutland
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital, Roskilde
state: Zeeland
city: Helsinki
country: Finland
facility: Helsingin yliopistollinen sairaala
state: Uusimaa
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Varisano - Klinikum Frankfurt Höchst GmbH
state: Hessen
city: Gießen
country: Germany
facility: UKGM - Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen
state: Hessen
city: Minden
country: Germany
facility: Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden -Friedrichstadt
state: Sachsen
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
state: Sachsen
city: Altenburg
country: Germany
facility: Klinikum Altenburger Land GmbH
state: Thüringen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck
city: Patra
country: Greece
facility: University General Hospital of Patras
state: Achaïa
city: Athens
country: Greece
facility: Alexandra Hospital
state: Attiki
city: Athina
country: Greece
facility: Naval Hospital of Athens
state: Attiki
city: Alexandroupoli
country: Greece
facility: University General Hospital of Alexandroupolis
state: Evros
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Irakleio
city: Athens
country: Greece
facility: University General Hospital ''ATTIKON''
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Larisa
country: Greece
facility: University General Hospital of Larissa
city: Thessaloniki
country: Greece
facility: AHEPA University General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki ''Hippokratio''
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital - PPDS
city: New Territories
country: Hong Kong
facility: Prince of Wales Hospital
city: New Territories
country: Hong Kong
facility: Princess Margaret Hospital - Hong Kong
city: Pécs
country: Hungary
facility: Pécsi Tudomanyegyetem - Vasvari Pal u.
state: Baranya
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz és Egyetemi Oktatokorhaz
state: Borsod-Abaúj-Zemplén
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
state: Hajdú-Bihar
city: Kistarcsa
country: Hungary
facility: Kistarcsai Flór Ferenc Kórház
state: Pest
city: Vác
country: Hungary
facility: Váci Jávorszky Ödön Kórház
state: Pest
city: Kisvárda
country: Hungary
facility: Szent Damjan Gorogkatolikus Korhaz
state: Szabolcs-Szatmár-Bereg
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
city: Budapest
country: Hungary
facility: Eszak-Pesti Centrumkorhaz -Honvedkorhaz
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika
city: Győr
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladár Egyetemi Oktató Kórház
city: Veszprém
country: Hungary
facility: Veszprém Vármegyei Csolnoky Ferenc Kórház
city: Ashdod
country: Israel
facility: Assuta Ashdod Medical Center
state: HaDarom
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
state: Haifa
city: Kfar Sava
country: Israel
facility: Meir Medical Center
state: HaMerkaz
city: Nahariya
country: Israel
facility: Galilee Medical Center
state: HaZafon
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center - PPDS
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah Medical Center - PPDS
state: Yerushalayim
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center - PPDS
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center - PPDS
city: Safed
country: Israel
facility: ZIV Medical Center
city: Toyohashi-Shi
country: Japan
facility: National Hospital Organization Toyohashi Medical Center
state: Aichi
city: Kisaratsu
country: Japan
facility: Kimitsu Chuo Hospital
state: Chiba
city: Takayama-Shi
country: Japan
facility: Takayama Red Cross Hospital
state: Gifu
city: Aki-gun
country: Japan
facility: Mazda Hospital of Mazda Motor Corporation
state: Hiroshima
city: Higashihiroshima-Shi
country: Japan
facility: National Hospital Organization Higashihiroshima Medical Center
state: Hiroshima
city: Kure-Shi
country: Japan
facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Social Medical Corporation hakuyoukai Kashiwaba Neurosurgical Hospital
state: Hokkaido
city: Kitakyushu-Shi
country: Japan
facility: Shin Komonji Hospital
state: Hukuoka
city: Kurume-Shi
country: Japan
facility: Our Lady of the Snow Social Medical Corporation St. Mary's Hospital
state: Hukuoka
city: Kobe-Shi Suma-Ku
country: Japan
facility: Shinsuma General Hospital
state: Hyôgo
city: Nishinomiya-Shi
country: Japan
facility: Hyogo Medical University Hospital
state: Hyôgo
city: Toride-Shi
country: Japan
facility: JA Toride Medical Center
state: Ibaraki
city: Tsukuba-Shi
country: Japan
facility: Tsukuba Medical Center Hospital
state: Ibaraki
city: Odawara-Shi
country: Japan
facility: Seisho Hospital
state: Kanagawa
city: Yokohama-Shi
country: Japan
facility: National Hospital Organization Yokohama Medical Center
state: Kanagawa
city: Beppu-Shi
country: Japan
facility: National Hospital Organization Beppu Medical Center
state: Oita
city: Izumisano-Shi
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Suita-Shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Hamada-Shi
country: Japan
facility: National Hospital Organization Hamada Medical Center
state: Shimane
city: Kakegawa-Shi
country: Japan
facility: Chutoen General Medical Center
state: Sizuoka
city: Shizuoka-Shi Aoi-Ku
country: Japan
facility: Shizuoka City Shizuoka Hospital
state: Sizuoka
city: Meguro-Ku
country: Japan
facility: Federation of National Public Service Personnel Mutual Aid Associations Mishuku Hospital
state: Tokyo
city: Ome-Shi
country: Japan
facility: Ome Medical Center
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Sumida-ku
country: Japan
facility: Tokyo Metropolitan Bokutoh Hospital
state: Tokyo
city: Yonezawa-Shi
country: Japan
facility: Sanyudo Hospital
state: Yamagata
city: Fukui
country: Japan
facility: Fukui Prefectural Hospital
city: Fukuoka
country: Japan
facility: Social Medical Corporation Foundation Chiyuukai Fukuoka Wajiro Hospital
city: Osaka
country: Japan
facility: Kotobuki Social Medical Corporation Tominaga Hospital
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Saitama
country: Japan
facility: Sainokuni Higashiomiya Medical Center
city: Suita-Shi
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Ôsaka
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Daegu Gwang'yeogsi
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggido
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Belgrade
country: Serbia
facility: Hospital for Cerebrovascular Diseases Sveti Sava
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia - Pasterova 2 - PPDS
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Nis
country: Serbia
facility: University Clinical Center Nis
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina
city: Zrenjanin
country: Serbia
facility: General Hospital Dr. Djordje Joanovic - Zrenjanin
city: Singapore
country: Singapore
facility: National University Hospital- Singapore
city: Singapore
country: Singapore
facility: Singapore General Hospital (SGH)
city: L'hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Barcelona
city: Vigo
country: Spain
facility: CHUVI - H.U. Alvaro Cunqueiro
state: Pontevedra
city: a Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Almeria
country: Spain
facility: Hospital Universitario Torrecardenas
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr Josep Trueta
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary - PPDS
state: Aberdeenshire
city: Luton
country: United Kingdom
facility: Luton and Dunstable Hospital
state: Bedfordshire
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital NHS Foundation Trust
state: Berkshire
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: London, City Of
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: Middlesex
city: London
country: United Kingdom
facility: The Royal London Hospital
state: Middlesex
city: London
country: United Kingdom
facility: National Hospital for Neurology & Neurosurgery
state: Middlesex
city: London
country: United Kingdom
facility: King's College Hospital
state: Surrey
city: Bury
country: United Kingdom
facility: Fairfield General Hospital - PPDS
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
References: