A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS)
Overview
- Phase
- Phase 2
- Intervention
- LT3001 Drug Product
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Lumosa Therapeutics Co., Ltd.
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- The Proportion of Subjects With Adverse Events (AEs), Judged to be Probably or Definitely Related to the Investigational Product (IP), Within 90 Days After the First IP Administration.
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
This is a phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS)
Detailed Description
This is a multicenter, double-blind, randomized, and placebo-controlled prospective Phase II clinical study, designed to evaluate LT3001 drug product versus placebo in subjects with AIS. The study is planned to take place in multiple countries. Subjects who participate in this trial should be treated with standard of care of AIS therapies when appropriate.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is aged 18 to 90 years.
- •Subject has an NIHSS of 6 to
- •Subject is able to receive the first IP within 24 hours after stroke symptoms onset.
- •Neuroimaging Inclusion Criteria:
- •Subject is able to undergo a contrast brain perfusion with either MRI or computed tomography (CT).
- •Subject has Target Mismatch Profile on MRI (perfusion is included) or CTP: ischemic core volume ≤70 mL, mismatch ratio ≥1.2 and mismatch volume ≥5 mL.
Exclusion Criteria
- •Subject has been treated or intent to treat with endovascular thrombectomy and/or intravenous thrombolytic during the current AIS.
- •Subject has a pre-stroke disability (mRS ≥2).
- •Subject has large ischemic core volume \>70 mL or ASPECTS ≤
- •Subject has symptoms of suspected subarachnoid hemorrhage.
- •Subject has imaging evidence of acute intracranial hemorrhage, intracranial tumor, arteriovenous malformations, other central nervous system lesions that could increase the risk of bleeding, or aneurysm requiring treatment.
- •Subject has significant mass effect with midline shift.
- •Subject has pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations.
- •Subject has current uncontrolled hypertension despite treatment.
- •Subject has INR \>1.7 or abnormal aPTT or platelet count \<100,000/mm\^
- •Subject has received conventional heparin or new oral anticoagulants within 48 hours before the first IP administration.
Arms & Interventions
LT3001 Drug Product
Administered by intravenous infusion
Intervention: LT3001 Drug Product
Placebo
Administered by intravenous infusion
Intervention: Placebo
Outcomes
Primary Outcomes
The Proportion of Subjects With Adverse Events (AEs), Judged to be Probably or Definitely Related to the Investigational Product (IP), Within 90 Days After the First IP Administration.
Time Frame: within 90 days after the first IP administration
There were no subjects in either treatment group who met the predefined criteria for the primary safety endpoint: the proportion of subjects with TEAEs judged to be probably or definitely related to the IP within 90 days after the first IP administration.