2025-522734-31-00招募中2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 67
- 试验地点
- 17
- 主要终点
- Parts A and B: Proportion of participants who develop symptomatic intracranial hemorrhage (sICH) within 120 hours after trial intervention, defined by the Heidelberg Bleeding Classification system.
研究概览
简要总结
Part A: To evaluate the safety and tolerability of TAK-755 in participants. Part B: To evaluate the safety and tolerability of TAK-755.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Informed Consent
- •The participant or legally authorized representative has provided informed consent before the initiation of any trial procedures.
- •Participants who are within 0 to 4.5 hours of stroke symptom onset at time of enrollment: Definition of Salvageable Brain Tissue, Part A and B • For sites that use perfusion imaging as part of SoC for this time window (CT perfusion or MR perfusion): – Initial ischemic core volume <70 cc. – Absolute volume of reversible ischemic tissue (penumbra) of ≥10 cc. – ASPECTS >6 (NCCT or DWI MRI). • For sites that do not use perfusion imaging as part of SoC for this time window or do not have perfusion imaging capability: – ASPECTS >6 (NCCT or DWI MRI). o ASPECTS: defined in Section 8.2.2.
- •18 to 80 years of age, inclusive, at the time of signing the informed consent form. See Section 13.4 for country-specific criteria
- •Clinical Characteristics
- •Clinical diagnosis of acute ischemic stroke (AIS).
- •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.
- •National Institutes of Health Stroke Scale score of 6 to 25, indicating moderate to severe stroke.
- •Estimated Modified Rankin Scale score <2 prior to AIS presentation, signifying no significant disability.
- •Signs and symptoms consistent with anterior circulation stroke.
- •Evidence of causative AIS occlusion on imaging (intracranial internal carotid artery [ICA], M1, M2, M3, M4, A1, A2, A3), either based on vascular imaging, corresponding perfusion deficit, or acute DWI MRI lesion in corresponding vascular territory.
- •Participants who are within >4.5 to 24 hours of stroke symptom onset at time of enrollment: Definition of Salvageable Brain Tissue • Part A and B: For sites that have perfusion imaging capability (computed tomography [CT] perfusion or magnetic resonance [MR] perfusion): – Initial ischemic core volume <70 cc. – Absolute volume of reversible ischemic tissue (penumbra) of ≥10 cc. – Alberta Stroke Programme Early CT Score (ASPECTS) >6 (non-contrast CT [NCCT] or diffusion weighted imaging [DWI] magnetic resonance imaging [MRI]). • Parts A and B: For sites that use MRI as part of screening: – Acute ischemic lesion visible on DWI but no marked parenchymal hyperintensity visible on FLAIR (DWI/FLAIR mismatch). – For large vessel occlusion (LVO; intracranial ICA, M1, M2 occlusions): ASPECTS >6 (DWI MRI). – For medium vessel occlusion (MVO; M3, M4 occlusions): ASPECTS >7 (DWI MRI). – For medium vessel occlusion (MVO; A1, A2, A3 occlusions): evidence of early ischemic change in less than one-third of corresponding anterior cerebral artery vascular territory (DWI MRI). • Part A Only: For sites that do not have MRI or perfusion imaging capability: – For large vessel occlusion (LVO; intracranial ICA, M1, M2 occlusions): ASPECTS >6 (NCCT). – For medium vessel occlusion (MVO; M3, M4 occlusions): ASPECTS >7 (NCCT). – For medium vessel occlusion (MVO; A1, A2, A3 occlusions): evidence of early ischemic change in less than one-third of corresponding anterior cerebral artery vascular territory (NCCT). – Presence of leptomeningeal collaterals that are visualized on single phase or multiphase CT angiography (CTA). o ASPECTS: defined in Section 8.2.2.3.
排除标准
- •Medical History
- •Weight >130 kg or <40 kg.
- •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.
- •Seizure at time of index AIS event onset.
- •History of severe traumatic brain injury in the past 90 days.
- •Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mm Hg) prior to randomization.
- •Blood glucose <50 mg/dL or >400 mg/dL.
- •History of intracranial hemorrhage.
- •History of intracranial neoplasm except for small meningioma.
- •History of prior stroke in the past 90 days.
- •History of intracranial or intraspinal surgery within the past 90 days.
- •Major surgery or severe trauma in the past 14 days.
- •Diagnosis of serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
- •History of cerebral amyloid angiopathy.
- •History of systemic malignancy, except for locally excised basal cell or squamous cell skin carcinoma with clear margins.
- •Current Medical Conditions
- •Active, uncontrolled bleeding.
- •Bleeding diathesis or any other conditions that would pose significant bleeding risk.
- •Inability to undergo MRI or CT.
- •Rapidly improving AIS symptoms.
- •Chronic causative intracranial occlusion.
- •Causative total occlusion of the extracranial ICA.
- •Evidence of septic emboli or bacterial endocarditis.
- •Another clinically significant concomitant disease that may pose additional risks for the participant in the opinion of the investigator.
- •Participation in other interventional clinical trials within the previous 90 days.
- •Pregnancy, lactation, or unable to comply with birth control methods or abstinence as specified in the protocol in the opinion of the investigator.
- •Poor quality imaging that precludes interpretation according to trial protocol.
- •Evidence of significant intracranial mass effect or midline shift.
- •Evidence of occlusion in >1 vascular territory.
- •Evidence of acute or chronic intracranial hemorrhage.
- •Evidence of extensive early ischemic change estimated to be greater than one-third of the middle cerebral artery territory.
- •Evidence of intracranial tumor (except incidental, small meningioma), cerebral aneurysm, or arteriovenous malformation.
- •Platelet count <50,000/mm
- •Identification by the investigator as being potentially unable or unwilling to cooperate with trial procedures.
- •Known life-threatening hypersensitivity reaction to TAK-755 or its components.
- •Any prior administration of TAK-
- •Administration of caplacizumab in the past 30 days.
- •Administration of von Willebrand factor-containing products in the past 14 days.
- •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
- •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.
研究组 & 干预措施
ADZYNMA 1 500 IU powder and solvent for solution for injection, ADZYNMA 1 500 IU powder and solvent for solution for injection, ADZYNMA 1 500 IU powder and solvent for solution for injection, ADZYNMA 1 500 IU powder and solvent for solution for injection
Test
干预措施: ADZYNMA 1 500 IU powder and solvent for solution for injection (Drug)
Lyophilized product with the same form and functional characteristics as TAK-755
Placebo
干预措施: Lyophilized product with the same form and functional characteristics as TAK-755 (Drug)
结局指标
主要结局
Parts A and B: Proportion of participants who develop symptomatic intracranial hemorrhage (sICH) within 120 hours after trial intervention, defined by the Heidelberg Bleeding Classification system.
Parts A and B: Proportion of participants who develop symptomatic intracranial hemorrhage (sICH) within 120 hours after trial intervention, defined by the Heidelberg Bleeding Classification system.
次要结局
- Part A: Proportion of participants with treatment-related and unrelated treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) within 90 days. • Proportion of participants with severe TEAEs within 90 days. • Proportion of participants with life-threatening adverse events (AEs) within 90 days. • Proportion of participants with AEs of special interest (AESIs).
- Part A continued: • Proportion of participants with clinically relevant changes in vital signs, clinical chemistry, and hematology. • Incidence of binding and neutralizing antibodies to ADAMTS13 from Day 30 to Day 90. • All-cause mortality within 90 days. • Proportion of participants with modified Rankin Scale (mRS) score of 0-1 at Day 90. • Proportion of participants with mRS score of 0-2 at Day 90. • Ordinal distribution of mRS at Day 90.
- Part A continued: • Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 hours. • Proportion of participants with recanalization at 24 hours, defined as complete recanalization with an arterial occlusive lesion (AOL) score of 3. • Proportion of participants with reperfusion at 24 hours, defined as >90% reduction in volume of reversible ischemic tissue (penumbra) from baseline. • Final infarct volume at 72 hours or discharge (if earlier than 72 hours).
- Part B: • Proportion of participants with mRS score of 0-1 at Day 90. • Proportion of participants with mRS score of 0-2 at Day 90 • Ordinal distribution of mRS at Day 90. • Change in NIHSS score from baseline at 24 hours.
- Part B continued: • Proportion of participants with recanalization at 24 hours, defined as complete recanalization with an AOL score of 3. • Proportion of participants with reperfusion at 24 hours, defined as >90% reduction in volume of reversible ischemic tissue (penumbra) from baseline. • Final infarct volume at 72 hours or hospital discharge (if earlier than 72 hours).
研究者
Charlene Chen
Scientific
Takeda Development Center Americas Inc.
研究点 (17)
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