A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT

NCT05198323 | Recruiting Phase 2 FDA Drug

• 1 other identifier: LT3001-203
• Study Type: interventional
• Target: 66
• Locations: 2 countries
• Sites: 2

Brief Summary

A phase IIb clinical study to evaluate the safety and efficacy of single or multiple doses of LT3001 drug product in subjects with acute ischemic stroke (AIS) undergoing endovascular thrombectomy (EVT).

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The occurrence of symptomatic intracranial hemorrhage within 24 hours after the single dosing; clinical deterioration defined as an change in the NIHSS of 4 points or more and confirmed by MRI

  Within 24 hours

Study Arms (2)

LT3001 Drug Product

EXPERIMENTAL

Administered by intravenous infusion

Drug: LT3001 Drug Product

Placebo

PLACEBO COMPARATOR

Administered by intravenous infusion

Drug: Placebo

Interventions

LT3001 Drug Product DRUG

LT3001 Drug Product administered once by intravenous infusion

LT3001 Drug Product

Placebo DRUG

Placebo administered once by intravenous infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject or subject's legal representative consents to participation by signing the informed consent form (ICF) after receiving full information about the study.
• Subject is aged 18 to 90 years, inclusive, at the time of Screening (Visit 1).
• Subject has an NIHSS ≥6.
• Subject is eligible to be treated with EVT within 24 hours after stroke symptoms onset. Subject has no severe contrast allergy or absolute contraindication to iodinated contrast preventing EVT, including any contraindications listed in the prescribing information approved by local regulatory authorities.
• Subject is able to receive the investigational product before EVT and within 24 hours after stroke symptoms onset.
• Subjects who are women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, are able and willing to use at least 1 highly effective method of contraception during the study until 3 months after dosing of investigational product.
• Subject is able to undergo a contrast brain perfusion with either MRI or computed tomography (CT).
• Subject is confirmed to have a symptomatic intracranial occlusion, based on magnetic resonance angiography (MRA)/computed tomography angiography (CTA) \* , at the following location: M1 middle cerebral artery (MCA), which is before bifurcation of M2. Functionally, when defining the M1 MCA, the bulk of the MCA territory must be ischemic.
• \* Only an intracranial MRA is required for subjects screened with MRA; cervical MRA is not required. Cervical and intracranial CTAs are typically obtained simultaneously in subjects screened with CTA, but only the intracranial CTA is required for enrollment.
• Subject has Target Mismatch Profile on MRI (perfusion is included) or CTP: ischemic core volume ≤70 mL, mismatch ratio \>1.2 \*\* .
• The mismatch ratio is determined by the RAPID software in real time based on the difference between the ischemic core lesion volume and the time-to-maximum (Tmax) \>6s lesion volume. If both a multimodal MRI and CTP are performed before enrollment, the later of the 2 scans is assessed to determine eligibility.
• If MRA/CTA is technically inadequate:
• Tmax \>6s perfusion deficit consistent with M1 MCA occlusion AND Target Mismatch Profile with ischemic core volume ≤70 mL, mismatch ratio \>1.2 as determined by RAPID software.
• If magnetic resonance perfusion (MRP) is technically inadequate:
• M1 MCA occlusion by MRA/CTA AND Diffusion Weighted Imaging (DWI) volume \<25 mL

You may not qualify if:

• Subject has been treated or intent to treat with intravenous thrombolytic during the current AIS, e.g., recombinant tissue-type plasminogen activator (rtPA).
• Subject has been treated with EVT before investigational product administration during the current AIS.
• Subject has a pre-stroke disability that requires help for activities of daily living (mRS ≥2).
• Subject has large ischemic core volume \>70 mL or Alberta Stroke Program Early CT Score (ASPECTS) of ≤5.
• Subject has symptoms of suspected subarachnoid hemorrhage, even if CT is normal.
• Subject has imaging evidence of acute intracranial hemorrhage, intracranial tumor (except small meningioma), 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 intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device.
• Subject has pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations, e.g., seizures at onset of the current AIS, dementia.
• Subject has current uncontrolled hypertension despite treatment: systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg before dosing at Screening (Visit 1).
• Subject has hemorrhagic diathesis, coagulation factor deficiency or recent oral anticoagulant therapy with International Normalized Ratio (INR) \>1.7 or activated partial thromboplastin time (aPTT) \>3 times of upper limit of normal range at Screening (Visit 1).
• Subject has received one of the new oral anticoagulants within 48 hours before treatment, e.g., dabigatran, apixaban.
• Subject has platelet count \<100,000/mm 3 at Screening (Visit 1).
• Subject has hemoglobin \<7 mmol/L at Screening (Visit 1).
• Subject has abnormal sodium concentration \<130 mmol/L and/or potassium concentration \<3 mEq/L or \>6 mEq/L at Screening (Visit 1).

Sponsors & Collaborators

• Lumosa Therapeutics Co., Ltd.: lead

Study Sites (2)

CHI Memorial Hospital

Chattanooga, Tennessee, 37404, United States

RECRUITING

Taichung Medical University

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Claire Sun

CONTACT

+886-2-26557918; claire_sun@lumosa.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 20, 2022
• Study Start: August 11, 2022
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

TW (1); US (1)