NCT05156827撤回2 期
A Phase 2 Double-blind, Randomized, Multi-center, Parallel-group Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Patients With Acute Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Percentage of Participants with Recovery Success Measured by modified Rankin Scale (mRS) score of 0-1 on the final mRS assessment.
研究概览
简要总结
This multi-center, randomized, parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of TB006 in participants with an Acute Ischemic Stroke (AIS) event with 57 days of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) between 18 and 40 kilograms per meters squared (kg/m^2), inclusive
- •Clinical diagnosis of AIS in anterior circulation, supported by evidence of a new stroke on acute brain computed tomography (CT) or magnetic resonance imaging (MRI) consistent with the clinical diagnosis.
- •Able to be randomized and dosed within 7 days of index stroke event. The last known awake time will be used for participants whose stoke occurred during sleep.
- •National Institute of Health Stroke Scale total score of 7 to 21, inclusive
- •Participants may have received standard of care therapy including recombinant tissue plasminogen activator (r-tPA), thrombectomy, mannitol, hypertonic saline, and other treatments per local guidelines as determined by the Investigator. Participants who have received r-tPA within the first day of their stroke event are eligible. However, study drug administration must begin more than 24 hours following r-tPA administration.
排除标准
- •Evidence of severe stroke on imaging (e.g., sulcal effacement or blurring of gray-white junction in greater than 1/3 of middle cerebral artery [MCA] territory, Alberta Stroke Program Early CT [ASPECT] score of 0 to 4 based on head CT, acute infarct volume on MRI diffusion weighed imaging ≥70 mL based on acute imaging studies performed under the standard of care
- •Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care
- •Evidence of seizure at the onset of index stroke
- •Evidence of acute myocardial infarction (MI) at Baseline, including any of the following:
- •Acute ST elevation MI;
- •Acute decompensated heart failure, or New York Heart Association Class III/IV heart failure;
- •Admission for an acute coronary syndrome, MI, cardiac arrest, or non-voluntary coronary intervention (percutaneous coronary intervention or coronary artery surgery) within the past 3 months.
- •QT interval corrected using Bazett's formula (QTcB) >520 milliseconds (msec).
- •Evidence of acute intracranial or subarachnoid hemorrhage or evidence of active bleeding based on acute brain CT or MRI performed under the standard of care. However, petechial hemorrhages of ≤ 1 centimeter (cm) are not exclusionary.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
TB006
Experimental
Participants will receive intravenous (IV) 3 infusions of 4000 milligrams (mg) TB006, one every 28 days (Q28D).
干预措施: TB006 (Drug)
Placebo
Placebo Comparator
Participants will receive an IV infusion of normal saline 500 milliliters (mL) Q28D.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants with Recovery Success Measured by modified Rankin Scale (mRS) score of 0-1 on the final mRS assessment.
时间窗: Day 90
The Modified Rankin Scale (mRS) measures neurological disability or dependence of participants with stroke on a scale of 0 to 6 and scores indicate the following: 0 - No symptoms; 1 - No significant disability; 2 - Slight disability; 3 - Moderate disability; 4 - Moderately severe disability; 5 - Severe disability; 6 - Dead. Higher score indicates worse condition.
次要结局
- Percentage of Participants with Clinically Significant Improvement on the mRS(At Days 29, 57 and 85)
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Day 141)
- Number of Participants with Clinically Significant Vital Sign Values(Up to Day 141)
- Number of Participants with Clinically Significant 12-Lead Electrocardiogram Findings(Up to Day 141)
- Plasma concentration of TB006(Pre-dose and post-dose on Days 1, 29, 57, 85 and 141)
- Change from Baseline in Neurological Function on the NIHSS(Baseline and through Day 85)
- Change from Baseline in the Montreal Cognitive Assessment (MoCA) Total Score(Baseline and at Days 29, 57, and 85)
- Number of Participants with Clinically Significant Physical Examination Findings(Up to Day 141)
- Percentage of Participants with Clinically Significant Improvement on the National Institutes of Health Stroke Scale (NIHSS)(At Days 29, 57 and 85)
- Number of Participants with Clinically Significant Clinical Laboratory Parameter Values(Up to Day 141)
- Number of Participants with Anti-drug Antibodies(Up to Day 141)
- Number of participants with Columbia Suicide Severity Rating Scale (C-SSRS) Score(Up to Day 141)
研究者
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