New stroke drug TAK-755 enters human trials – could improve recovery

NCT ID NCT07392450

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This phase 2 trial is testing whether TAK-755, a lab-made protein that helps break up blood clots, is safe and effective for people who have had an acute ischemic stroke. About 222 adults aged 18 to 80 will receive either TAK-755 or a placebo, along with standard stroke care, and be monitored for 90 days. The main goal is to check for bleeding in the brain, while also seeing if the drug helps reduce stroke severity and improve daily functioning.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TAK-755 (a lab-made version of a natural protein that helps break up blood clots)
What this could lead to: If it works, this could lead to a new treatment that helps people recover better after a stroke and reduces long-term disability.
What could go wrong: This is an early phase 2 trial with only 222 people, so results may not apply to everyone. There is also a risk of bleeding in the brain, which the study is carefully monitoring.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 222 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

60 sites in 10 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

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

Belagavi, Karnataka, 590010, India
AHEPA University General Hospital of Thessaloniki
NOT_YET_RECRUITING

Thessaloniki, 54636, Greece
AZ Groeninge
NOT_YET_RECRUITING

Kortrijk, WVL, 8500, Belgium
Aberdeen Royal Infirmary
NOT_YET_RECRUITING

Cornhill, Aberdeen, AB25 2ZD, United Kingdom
All India Institute of Medical Sciences, New Delhi, Department of Neurology
NOT_YET_RECRUITING

New Delhi, 110029, India
Amrita Institute Of Medical Sciences and Research Centre
NOT_YET_RECRUITING

Kochi, Kerala, 682041, India
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Raymond-Poincare
NOT_YET_RECRUITING

Garches, IDF, 92380, France
Athens Navy Hospital
NOT_YET_RECRUITING

Athens, 11521, Greece
Bangur Institute of Neurosciences
NOT_YET_RECRUITING

Kolkata, West Bengal, 700020, India
Bedfordshire Hospitals NHS Foundation Trust
NOT_YET_RECRUITING

Luton, Bedfordshire, LU4 0DZ, United Kingdom
Beijing Tiantan Hospital, Capital Medical University
RECRUITING

Beijing, Beijing Municipality, 100070, China
Bicetre Hospital
NOT_YET_RECRUITING

Le Kremlin-Bicêtre, IDF, 94270, France
CHU Bordeaux, CHU Pellegrin
NOT_YET_RECRUITING

Bordeaux, Aquitaine, 33076, France
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
NOT_YET_RECRUITING

Liège, 4000, Belgium
Charite Universitatsmedizin Berlin
NOT_YET_RECRUITING

Berlin, 12203, Germany
Christian Medical College, Ludhianana
NOT_YET_RECRUITING

Ludhiana, Punjab, 141008, India
Fukuoka Wajiro Hospital
RECRUITING

Fukuoka, Fukuoka, 811-0213, Japan
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
NOT_YET_RECRUITING

São José do Rio Preto, São Paulo, 15090-000, Brazil
Goethe-Universitaet-Universitaetsmedizin Frankfurt-Zentrum der Neurologie und Neurochirurgie (ZNN)
NOT_YET_RECRUITING

Frankfurt am Main, Hesse, 60590, Germany
Groupe Hospitalier Bichat Claude Bernard
NOT_YET_RECRUITING

Paris, IDF, 75018, France
Groupe sante CHC - Clinique du MontLegia
NOT_YET_RECRUITING

Liège, 4000, Belgium
HCA Houston Healthcare - North Cypress
NOT_YET_RECRUITING

Cypress, Texas, 77429, United States
HonorHealth Neurology
RECRUITING

Scottsdale, Arizona, 85251, United States
Hopital Lariboisiere
NOT_YET_RECRUITING

Paris, IDF, 78600, France
Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - Universidade de Sao Paulo
NOT_YET_RECRUITING

Ribeirão Preto, São Paulo, 14048-900, Brazil
Hospital Moinhos de Vento
RECRUITING

Porto Alegre, Rio Grande do Sul, 90560-032, Brazil
Hospital Sao Paulo / Escola Paulista de Medicina da Universidade Federal de Sao Paulo (EPM/UNIFESP)
NOT_YET_RECRUITING

São Paulo, São Paulo, 04022-001, Brazil
Imperial College Healthcare NHS Trust, St. Mary's Hospital
NOT_YET_RECRUITING

London, W2 1NY, United Kingdom
Klinikum Ernst von Bergmann
NOT_YET_RECRUITING

Potsdam, Brandenburg, 14467, Germany
Kotobukikai Tominaga Hospital
NOT_YET_RECRUITING

Osaka, Osaka, 556-0017, Japan
Liaocheng People's Hospital
RECRUITING

Liaocheng, Shandong, 252000, China
Linfen Central Hospital
RECRUITING

Linfen, Shanxi, 041099, China
Linyi People's Hospital
RECRUITING

Linyi, Shandong, 276000, China
Massachusetts General Hospital
NOT_YET_RECRUITING

Boston, Massachusetts, 02114, United States
NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital
NOT_YET_RECRUITING

Glasgow, Lanarkshire, G51 4TF, United Kingdom
Nagano Municipal Hospital
RECRUITING

Nagano, Nagano, 381-8551, Japan
Nanshi Hospital of Nanyang
RECRUITING

Nanyang, Henan, 473003, China
Neurology Consultants of Dallas, PA
NOT_YET_RECRUITING

Dallas, Texas, 75243, United States
Porto Alegre Clinical Hospital (HCPA)
NOT_YET_RECRUITING

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Qilu Hospital of Shandong University
RECRUITING

Jinan, Shandong, 250012, China
Rinku General Medical Center
NOT_YET_RECRUITING

Izumisano, Osaka, 598-8577, Japan
Saiseikai Fukuoka General Hospital
RECRUITING

Fukuoka, Fukuoka, 810-0001, Japan
Second Department of Neurology, National and Kapodistrian University of Athens, "Attikon" University Hospital
NOT_YET_RECRUITING

Chaïdári, Attica, 12462, Greece
Sinopharm Tongmei General Hospital
RECRUITING

Datong, Shanxi, 037000, China
Technische Universitaet Dresden-Universitaetsklinikum Carl Gustav Carus
NOT_YET_RECRUITING

Dresden, Saxony, 01307, Germany
The Affiliated Hospital of Xuzhou Medical University
RECRUITING

Xuzhou, Jiangsu, 221000, China
Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu
NOT_YET_RECRUITING

Botucatu, São Paulo, 18618-687, Brazil
Universidade Estadual de Campinas (UNICAMP)
NOT_YET_RECRUITING

Campinas, São Paulo, 13083-888, Brazil
Universitaetsklinikum Heidelberg (UKHD)
NOT_YET_RECRUITING

Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitaetsklinikum Tuebingen
NOT_YET_RECRUITING

Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsmedizin Goettingen
NOT_YET_RECRUITING

Göttingen, Lower Saxony, 37075, Germany
Universitair Ziekenhuis Gent (Belgium,Ghent)
NOT_YET_RECRUITING

Ghent, Oost-Vlaanderen, 9000, Belgium
University Hospital of Alexandroupolis
NOT_YET_RECRUITING

Alexandroupoli, Evros, 68100, Greece
University at Buffalo
NOT_YET_RECRUITING

Buffalo, New York, 14202, United States
University of Arizona
NOT_YET_RECRUITING

Tucson, Arizona, 85724, United States
University of California San Francisco
NOT_YET_RECRUITING

San Francisco, California, 94143, United States
University of Glasgow - PPDS
NOT_YET_RECRUITING

Glasgow, Lanarkshire, G4 0SF, United Kingdom
University of Pittsburgh Medical Center
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
NOT_YET_RECRUITING

Nashville, Tennessee, 37232, United States
Ziekenhuis Oost-Limburg
NOT_YET_RECRUITING

Genk, Limburg, 3600, Belgium

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