Phase 2 Stroke Trial, Recruiting NCT07392450 Sponsor: Takeda Condition: Stroke
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Phase 2 Stroke Trial, Recruiting

NCT07392450
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The person joining (or their legal representative) has agreed to take part by signing a consent form before any trial procedures begin.
  • Adults aged 18 to 80 years old at the time of signing the consent form.
  • People who have been clinically diagnosed with an acute ischaemic stroke (a stroke caused by a blockage).
  • People whose stroke symptoms began within 24 hours before enrolment — including "wake-up strokes," where the last time the person was known to be well was within 24 hours of enrolment.
  • People whose stroke is rated as moderate to severe, based on a standard stroke severity scoring tool (a score of 6 to 25 on the NIH Stroke Scale).
  • People who had little to no disability before this stroke, based on a standard disability scale (a Modified Rankin Scale score below 2 before the stroke).
  • People whose stroke symptoms suggest the blockage is in the front part of the brain's blood supply (called the anterior circulation).
  • People whose brain scan shows a blockage in one of several specific blood vessels in the brain (confirm with trial site for exact vessel details).
  • People whose brain scan shows there is still brain tissue that could potentially be saved.

Who may not be able to join:

  • People who weigh more than 130 kilograms or less than 40 kilograms.
  • People who have had a severe traumatic brain injury in the past 90 days.
  • People with a history of bleeding inside the brain (intracranial haemorrhage).
  • People with a history of a brain tumour, except for a small, slow-growing type called a meningioma.
  • People who have had a stroke in the past 90 days.
  • People who have had brain or spinal surgery in the past 90 days.
  • People who have had major surgery or a serious physical injury in the past 14 days.
  • People with a history of a condition called cerebral amyloid angiopathy, which affects blood vessels in the brain.
  • People with a history of cancer anywhere in the body, except for certain skin cancers (basal cell or squamous cell) that were fully removed with clear margins.
  • People with a serious or terminal illness where life expectancy is estimated to be less than one year.
  • People who have taken part in another interventional clinical trial within the past 90 days.
  • People with a known severe allergic reaction to the study drug (TAK-755) or any of its ingredients.
  • People who have previously received the study drug TAK-755 at any time.
  • People who have received a drug called caplacizumab in the past 30 days.
  • People who have received products containing von Willebrand factor in the past 14 days.
  • People who, in the view of the trial doctor, are unable to understand what taking part in the trial involves (based on conditions present before this stroke).
  • People who have already received certain clot-dissolving medications (such as alteplase, tenecteplase, prourokinase, or reteplase) for this stroke.
  • People who, according to the trial site's standard guidelines, would be eligible to receive standard clot-dissolving medication for this stroke and where that treatment is directly available.
  • People for whom the treating medical team plans to carry out a procedure to physically remove the clot (called endovascular thrombectomy), where that procedure is available.
  • People who had a seizure at the time this stroke began.
  • People whose blood pressure remains very high (systolic 185 mmHg or above, or diastolic 110 mmHg or above) before being assigned to a treatment group.
  • People with blood sugar levels that are very low (below 50 mg/dL) or very high (above 400 mg/dL).
  • People with active, uncontrolled bleeding.
  • People with a condition that causes difficulty with blood clotting or that would raise the risk of serious bleeding.
  • People who are unable to have a brain scan (MRI or CT).
  • People whose stroke symptoms are improving rapidly on their own.
  • People whose brain artery blockage is long-standing rather than caused by a new event.
  • People with a complete blockage of the main artery in the neck (extracranial internal carotid artery) that is causing this stroke.
  • People whose scan shows signs of infection-related clots or a heart valve infection (septic emboli or bacterial endocarditis).
  • People with another significant medical condition that, in the trial doctor's opinion, would put them at additional risk.
  • People who are pregnant, breastfeeding, or who are unable to use the birth control methods required by the trial protocol (in the opinion of the trial doctor).
  • People whose brain scan images are too poor in quality to be assessed according to the trial's requirements.
  • People whose brain scan shows significant swelling or shifting of brain structures.
  • People whose scan shows a blockage affecting more than one area of the brain's blood supply.
  • People whose scan shows any bleeding in the brain, whether new or old.
  • People whose scan shows that a large area of the brain (more than one-third of a major territory called the middle cerebral artery territory) has already been affected.
  • People whose scan shows a brain tumour (other than a small meningioma), a brain aneurysm, or an abnormal tangle of blood vessels (arteriovenous malformation).
  • People with a very low platelet count (below 50,000 per cubic millimetre), as platelets help blood to clot.
  • People who the trial doctor believes may be unable or unwilling to follow the trial procedures.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Study Director, Takeda

Phone: +1-877-825-3327

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
7 April 2026
Est. completion
6 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Part A and B: Percentage of Participants who Develop Symptomatic Intracranial Hemorrhage (sICH) as Defined by the Heidelberg Bleeding Classification System

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov