TAK-755 to treat acute ischemic stroke in adults

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke

This will test a single dose of TAK-755 versus placebo to see if it is safe and helps adults who had an acute ischemic stroke within 24 hours.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Takeda (Industry-sponsored)
• Drugs / interventions: caplacizumab
• Locations: 1 site (Scottsdale, Arizona)
• Trial ID: NCT07392450 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, randomized interventional study comparing a single dose of TAK-755 to placebo in adults with acute ischemic stroke. Eligible participants are 18–80 years old with moderate-to-severe stroke (NIHSS 6–25), anterior circulation occlusion on imaging, and symptom onset or last-known-well within 24 hours. The main goals are to characterize safety and tolerability and to collect preliminary data on effects on stroke severity and functional ability compared with placebo. Participants receive either TAK-755 or placebo once and are followed for clinical outcomes.

Who should consider this trial

Good fit: Adults aged 18–80 with a clinical diagnosis of acute ischemic stroke, NIHSS 6–25, anterior circulation occlusion on imaging, and symptom onset or last-known-well within 24 hours are the intended participants.

Not a fit: Patients with pre-existing significant disability (modified Rankin Scale ≥2), strokes outside the anterior circulation, or those presenting more than 24 hours after last-known-well are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, TAK-755 could offer an additional acute treatment that reduces stroke severity and improves everyday function after ischemic stroke.

How similar studies have performed: Previous neuroprotective and acute stroke drug trials have often been unsuccessful, so this approach remains novel and largely unproven in large-scale clinical practice.

Eligibility criteria

Inclusion Criteria:

Informed Consent:

1. The participant or legally authorized representative has provided informed consent before the initiation of any trial procedures.

   Age:
2. 18 to 80 years of age, inclusive, at the time of signing the informed consent form.

   Clinical Characteristics:
3. Clinical diagnosis of AIS.
4. Onset of stroke symptoms within 24 hours of enrollment. Wake-up strokes may be included if Last Known Well is within 24 hours of enrollment; time of onset will be considered the time of Last Known Well.
5. National Institutes of Health Stroke Scale score of 6 to 25, indicating moderate to severe stroke.
6. Estimated Modified Rankin Scale score less than (\<) 2 prior to AIS presentation, signifying no significant disability.
7. Signs and symptoms consistent with anterior circulation stroke.

   Imaging:
8. Evidence of causative AIS occlusion on imaging (intracranial internal carotid artery \[ICA\], M1, M2, M3, M4, A1, A2, A3).
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. History of systemic malignancy, 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.
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. Rapidly improving AIS symptoms.
27. Chronic causative intracranial occlusion.
28. Causative total occlusion of the extracranial ICA.
29. Evidence of septic emboli or bacterial endocarditis.
30. Another clinically significant concomitant disease that may pose additional risks for the participant in the opinion of the investigator.
31. Pregnancy, lactation, or unable to comply with birth control methods or abstinence as specified in the protocol in the opinion of the investigator.

    Imaging:
32. Poor quality imaging that precludes interpretation according to trial protocol.
33. Evidence of significant intracranial mass effect or midline shift.
34. Evidence of occlusion in \>1 vascular territory.
35. Evidence of acute or chronic intracranial hemorrhage.
36. Evidence of extensive early ischemic change estimated to be greater than one-third of the middle cerebral artery territory.
37. Evidence of intracranial tumor (except incidental, small meningioma), cerebral aneurysm, or arteriovenous malformation.

    Laboratory:
38. Platelet count \<50,000/ cubic millimeters (mm\^3).

    Other:
39. Identification by the investigator as being potentially unable or unwilling to cooperate with trial procedures.

Where this trial is running

Scottsdale, Arizona

• Honor Health — Scottsdale, Arizona, United States (Recruiting)

Study contacts

• Study coordinator: Takeda Contact

Conditions Acute Ischemic Stroke; Drug therapy