Back to resultsA Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects (BRIGHT)
Primary Purpose
Acute Ischemic Stroke
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LT3001 Drug Product
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- Subject is aged 18 to 90 years.
- Subject has an NIHSS of 6 to 25.
- 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 ≤5.
- 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^3.
- Subject has received conventional heparin or new oral anticoagulants within 48 hours before the first IP administration.
- Subject has blood glucose concentration <50 mg/dL or >400 mg/dL.
- Subject has moderate or severe hepatic, renal, and/or active infectious disease.
- Subject is lactating, pregnant, or planning to become pregnant during the study.
- Subject has had history of sICH, prior AIS, myocardial infarction, or serious head trauma within 90 days before Screening.
- Subject has had any major surgery within 90 days before Screening.
- Subject has had a bleeding event within 21 days before Screening.
- Subject has puncture of noncompressible vessels within 7 days before Screening.
- Subject has participated in another investigational study and received IP within 30 days before Screening or 5 half-lives (whichever is longer).
- In the opinion of the Investigator, the subject is not appropriate for the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LT3001 Drug Product
Placebo
Arm Description
Administered by intravenous infusion
Administered by intravenous infusion
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05403866
First Posted
May 31, 2022
Last Updated
May 31, 2022
Sponsor
Lumosa Therapeutics Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05403866
Brief Title
A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects
Acronym
BRIGHT
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumosa Therapeutics Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LT3001 Drug Product
Arm Type
Experimental
Arm Description
Administered by intravenous infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
LT3001 Drug Product
Intervention Description
Administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by intravenous infusion
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is aged 18 to 90 years.
Subject has an NIHSS of 6 to 25.
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 ≤5.
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^3.
Subject has received conventional heparin or new oral anticoagulants within 48 hours before the first IP administration.
Subject has blood glucose concentration <50 mg/dL or >400 mg/dL.
Subject has moderate or severe hepatic, renal, and/or active infectious disease.
Subject is lactating, pregnant, or planning to become pregnant during the study.
Subject has had history of sICH, prior AIS, myocardial infarction, or serious head trauma within 90 days before Screening.
Subject has had any major surgery within 90 days before Screening.
Subject has had a bleeding event within 21 days before Screening.
Subject has puncture of noncompressible vessels within 7 days before Screening.
Subject has participated in another investigational study and received IP within 30 days before Screening or 5 half-lives (whichever is longer).
In the opinion of the Investigator, the subject is not appropriate for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessie Wu
Phone
+886-2-26557918
Ext
5717
Email
jessie_wu@lumosa.com.tw
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects
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