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NCT07392450PHASE2Recruiting

A Study of TAK-755 in Adults With Acute Ischemic Stroke

Takeda

Start Date

5/17/2026

Completion Date

12/6/2027

Summary

Acute ischemic stroke (AIS) is a medical emergency that happens because of a sudden stop of blood flow to a part of the brain. This happens when a blood clot forms within the vessel (known as thrombotic occlusion) or a clot originating from somewhere else blocks a blood vessel (known as embolic occlusion). Strokes can cause serious health problems, death, and affect one's quality of life. To reduce long-term damage, it is important to restore blood flow to the brain as soon as possible. The main aim of this study is to check how safe TAK-755 is, and how well adults with AIS tolerate it. Other aims are to check how well TAK-755 helps participants to manage their everyday activities and to understand whether it helps reduce the seriousness of their stroke symptoms when compared to placebo. A placebo looks like TAK-755, but does not have any medicine in it, to make sure participants do not know which treatment they are taking. The participants will receive TAK-755 or placebo once; afterwards, their health will be monitored for about 3 months (90 days). All participants, regardless of their assignment to either TAK-755 or placebo, will receive the usual treatment for AIS as per the hospital's normal practice.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: Informed Consent: 1. The participant or legally authorized representative has provided informed consent or deferred consent eligibility confirmed before the initiation of any trial procedures. Age: 2. greater than and equal to (\>=) 18 years of age, inclusive, at the time of signing the Informed Consent Form (ICF) or confirmation of deferred consent eligibility. Clinical Characteristics: 3. Clinical diagnosis of AIS. 4. Onset of stroke symptoms within 24 hours of randomization. Wake-up strokes may be included if Last Known Well is within 24 hours of randomization; time of onset will be considered the time of Last Known Well. 5. National Institutes of Health Stroke Scale score of 5 to 25, indicating moderate to severe stroke. Participants with an NIHSS score of 5 are eligible only if at least 1 predefined disabling neurological deficit is present, as defined by one or more of the following NIHSS criteria: * Complete hemianopia (NIHSS visual score \>=2). * Aphasia impairing meaningful communication (NIHSS language score \>=2). * Motor deficit with inability to sustain effort against gravity (NIHSS left or right motor arm or leg score \>=2). 6. Estimated Modified Rankin Scale score less than (\<) 2 prior to AIS presentation, signifying no significant disability. 7. Persistent neurological signs and symptoms consistent with unilateral supratentorial circulation stroke. Imaging: 8. Evidence of causative AIS occlusions affecting supratentorial circulation on imaging (intracranial internal carotid artery \[ICA\], middle cerebral artery \[MCA; M1 - M4\], anterior cerebral artery \[ACA; A1 - A3\], posterior cerebral artery \[PCA; P1 - P3\]). 9. Evidence of salvageable brain tissue on CT or MR imaging. Exclusion Criteria: Medical History: 1. Weight \>130 kilograms (kg) or \<40 kg. 2. History of severe traumatic brain injury in the past 90 days. 3. History of intracranial hemorrhage. 4. History of intracranial neoplasm except for small meningioma. 5. History of prior stroke in the past 90 days. 6. History of intracranial or intraspinal surgery within the past 90 days. 7. Major surgery or severe trauma in the past 14 days. 8. History of cerebral amyloid angiopathy. 9. Recent history of active systemic malignancy within the last 5 years, except for locally excised basal cell or squamous cell skin carcinoma with clear margins. 10. Diagnosis of serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year. 11. Participation in other interventional clinical trials within the previous 90 days. 12. Known life-threatening hypersensitivity reaction to TAK-755 or its components. 13. Any prior administration of TAK-755. 14. Administration of caplacizumab in the past 30 days. 15. Administration of von Willebrand factor-containing products in the past 14 days. 16. Baseline conditions (prior to the index AIS event) that prevent an understanding of the nature, scope, and possible consequences of the trial, in the judgment of the investigator. Current Stroke Management: 17. Any prior administration (intravenous or intra-arterial) of alteplase or tenecteplase for the index AIS event, as well as any prior administration of prourokinase or reteplase for the index AIS event in countries where approved. 18. Eligible for administration of intravenous thrombolysis (alteplase or tenecteplase, as well as prourokinase or reteplase in countries where approved) for the index AIS event, based on the site's standard clinical guidelines and direct availability. 19. Intent to proceed with endovascular thrombectomy (EVT) for the index AIS event based on eligibility and direct availability. 20. Seizure at time of index AIS event onset, only if it precludes accurate assessment of baseline NIHSS. 21. Persistent blood pressure elevation (systolic \>=185 millimeters of mercury \[mmHg\] or diastolic \>=110 mm Hg) prior to randomization. 22. Blood glucose \<50 milligrams per deciliter (mg/dL) or \>400 mg/dL. Current Medical Conditions: 23. Active, uncontrolled bleeding. 24. Bleeding diathesis or any other conditions that would pose significant bleeding risk. 25. Inability to undergo MRI or CT. 26. Chronic causative intracranial occlusion. 27. Causative total occlusion of the extracranial ICA. 28. Evidence of septic emboli or bacterial endocarditis. 29. Another clinically significant concomitant disease that may pose additional risks for the participant in the opinion of the investigator. 30. Pregnancy, lactation, or unable to comply with birth control methods or abstinence as specified in the protocol in the opinion of the investigator. Imaging: 31. Poor quality imaging that precludes interpretation according to trial protocol. 32. Evidence of significant intracranial mass effect or midline shift. 33. Evidence of acute occlusion in \>1 vascular territory (right/left MCA, right/left ACA, right/left PCA); multiple occlusions within the same vascular territory are allowed. 34. Evidence of acute or chronic intracranial hemorrhage (presence of chronic cerebral microbleeds on magnetic resonance imaging \[MRI\]) T2\*-weighted type sequence (such as gradient recalled echo \[GRE\] or susceptibility weighted imaging \[SWI\]) is not exclusionary if total \<10 and not consistent with diagnosis of cerebral amyloid angiopathy). 35. Evidence of extensive early ischemic change estimated to be greater than one-third of the middle cerebral artery territory or evidence of well-demarcated hypoattenuation on computed tomography (CT), if performed, consistent with established infarction and judged by the investigator to correspond to the clinical symptoms of the index AIS. 36. Evidence of intracranial tumor (except incidental, small meningioma), cerebral aneurysm, or arteriovenous malformation. Laboratory: 37. Platelet count \<50,000/ cubic millimeters (mm\^3). Other: 38. Identification by the investigator as being potentially unable or unwilling to cooperate with trial procedures.

Interventions

BIOLOGICAL

TAK-755

OTHER

Placebo

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Conditions

Acute Ischemic Stroke

Locations

HonorHealth Neurology

Scottsdale, Arizona 85251

United States

University of Arizona

Tucson, Arizona 85724

United States

University of California San Francisco

San Francisco, California 94143

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

University at Buffalo

Buffalo, New York 14202

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

HCA Houston Healthcare - North Cypress

Cypress, Texas 77429

United States

Neurology Consultants of Dallas, PA

Dallas, Texas 75243

United States

Ziekenhuis Oost-Limburg

Genk, Limburg 3600

Belgium

Universitair Ziekenhuis Gent (Belgium,Ghent)

Ghent, Oost-Vlaanderen 9000

Belgium

AZ Groeninge

Kortrijk, WVL 8500

Belgium

Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman

Liège, 4000

Belgium

Groupe sante CHC - Clinique du MontLegia

Liège, 4000

Belgium

Porto Alegre Clinical Hospital (HCPA)

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul 90560-032

Brazil

Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu

Botucatu, São Paulo 18618-687

Brazil

Universidade Estadual de Campinas (UNICAMP)

Campinas, São Paulo 13083-888

Brazil

Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - Universidade de Sao Paulo

Ribeirão Preto, São Paulo 14048-900

Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo 15090-000

Brazil

Hospital Sao Paulo / Escola Paulista de Medicina da Universidade Federal de Sao Paulo (EPM/UNIFESP)

São Paulo, São Paulo 04022-001

Brazil

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality 100070

China

Nanshi Hospital of Nanyang

Nanyang, Henan 473003

China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu 221000

China

Qilu Hospital of Shandong University

Jinan, Shandong 250012

China

Liaocheng People's Hospital

Liaocheng, Shandong 252000

China

Linyi People's Hospital

Linyi, Shandong 276000

China

Sinopharm Tongmei General Hospital

Datong, Shanxi 037000

China

Linfen Central Hospital

Linfen, Shanxi 041099

China

CHU Bordeaux, CHU Pellegrin

Bordeaux, Aquitaine 33076

France

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Raymond-Poincare

Garches, IDF 92380

France

Bicetre Hospital

Le Kremlin-Bicêtre, IDF 94270

France

Groupe Hospitalier Bichat Claude Bernard

Paris, IDF 75018

France

Hopital Lariboisiere

Paris, IDF 78600

France

Universitaetsklinikum Heidelberg (UKHD)

Heidelberg, Baden-Wurttemberg 69120

Germany

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg 72076

Germany

Klinikum Ernst von Bergmann

Potsdam, Brandenburg 14467

Germany

Goethe-Universitaet-Universitaetsmedizin Frankfurt-Zentrum der Neurologie und Neurochirurgie (ZNN)

Frankfurt am Main, Hesse 60590

Germany

Universitaetsmedizin Goettingen

Göttingen, Lower Saxony 37075

Germany

Technische Universitaet Dresden-Universitaetsklinikum Carl Gustav Carus

Dresden, Saxony 01307

Germany

Charite Universitatsmedizin Berlin

Berlin, 12203

Germany

Second Department of Neurology, National and Kapodistrian University of Athens, "Attikon" University Hospital

Chaïdári, Attica 12462

Greece

University Hospital of Alexandroupolis

Alexandroupoli, Evros 68100

Greece

Athens Navy Hospital

Athens, 11521

Greece

AHEPA University General Hospital of Thessaloniki

Thessaloniki, 54636

Greece

AES - AS - KLES Dr Prabhakar Kore Hospital and Medical Research Centre

Belagavi, Karnataka 590010

India

Amrita Institute Of Medical Sciences and Research Centre

Kochi, Kerala 682041

India

Christian Medical College, Ludhianana

Ludhiana, Punjab 141008

India

Bangur Institute of Neurosciences

Kolkata, West Bengal 700020

India

All India Institute of Medical Sciences, New Delhi, Department of Neurology

New Delhi, 110029

India

Saiseikai Fukuoka General Hospital

Fukuoka, Fukuoka 810-0001

Japan

Fukuoka Wajiro Hospital

Fukuoka, Fukuoka 811-0213

Japan

Nagano Municipal Hospital

Nagano, Nagano 381-8551

Japan

Rinku General Medical Center

Izumisano, Osaka 598-8577

Japan

Kotobukikai Tominaga Hospital

Osaka, Osaka 556-0017

Japan

Aberdeen Royal Infirmary

Cornhill, Aberdeen AB25 2ZD

United Kingdom

Bedfordshire Hospitals NHS Foundation Trust

Luton, Bedfordshire LU4 0DZ

United Kingdom

University of Glasgow - PPDS

Glasgow, Lanarkshire G4 0SF

United Kingdom

NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital

Glasgow, Lanarkshire G51 4TF

United Kingdom

Imperial College Healthcare NHS Trust, St. Mary's Hospital

London, W2 1NY

United Kingdom