Acute Ischemic StrokePhase 2NCT05198323
A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT
A Phase 2 study testing LT3001 Drug Product in people with Acute Ischemic Stroke, run by Lumosa Therapeutics Co., Ltd. at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- LT3001 Drug Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Aug 2022to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Neuroimaging Inclusion Criteria:
- 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.
- [Alternative Neuroimaging Inclusion Criteria]
- 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
- If CTP is technically inadequate:
- Subject can be screened with MRI and enrolled if neuroimaging criteria are met.
Who cannot join
- 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.
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- 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).
- Subject has blood glucose concentration <50 mg/dL or >400 mg/dL at Screening (Visit 1).
- Subject has severe hepatic, renal, and/or active infectious disease at Screening (Visit 1).
- Subject is lactating, pregnant (pregnancy test required for all female subjects of childbearing potential), or planning to become pregnant during the study.
- Subject has had prior AIS, myocardial infarction, or serious head trauma within 90 days of Screening (Visit 1).
- Subject has history of ICH within 90 days of Screening (Visit 1).
- Subject has had any major surgery within 90 days of Screening (Visit 1), e.g., intracranial or intraspinal surgery, coronary artery bypass graft, obstetrical delivery, organ biopsy.
- Subject has had a bleeding event within 21 days of Screening (Visit 1), e.g., gastrointestinal or hemorrhage.
- Subject has puncture of noncompressible vessels within 7 days of Screening (Visit 1).
- Subject has participated in another investigational study and received investigational product within 30 days of Screening (Visit 1) or 5 half-lives (whichever is longer).
- In the opinion of the Investigator, the subject is precluded from EVT procedure, or a significant hazard is posed to the subject if EVT procedure is performed.
- In the opinion of the Investigator, the subject has serious, advanced, or terminal illness that will prevent improvement or follow-up visits.
- In the opinion of the Investigator, the subject is not appropriate for the study for any other reason.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase II, Two-Part, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS) Undergoing Endovascular Thrombectomy (EVT)
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).
Read the detailed description
This is a 2-part, multicenter, double-blind, randomized, and placebo-controlled prospective Phase II clinical study, designed to evaluate LT3001 drug product versus placebo in subjects with AIS undergoing EVT. Subjects who participate in this trial should be treated with standard of care (SoC) of AIS therapies when appropriate.
- Conditions
- Acute Ischemic Stroke
- Being tested
- LT3001 Drug Product, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT3001 Drug ProductDrug
LT3001 Drug Product administered once by intravenous infusion
PlaceboDrug
Placebo administered once by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| LT3001 Drug Product | Experimental | Administered by intravenous infusion Receives: Drug: LT3001 Drug Product |
| Placebo | Placebo comparator | Administered by intravenous infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start11 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumosa Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198323
- Sponsor's protocol ID
- LT3001-203
- Status last verified
- Aug 2026
- First submitted
- 3 Jan 2022
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Two-Part, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects With Acute Ischemic Stroke (AIS) Undergoing Endovascular Thrombectomy (EVT)
- ClinicalTrials.gov ID
- NCT05198323
- Acronym / sponsor ID
- LT3001-203
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Lumosa Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a 2-part, multicenter, double-blind, randomized, and placebo-controlled prospective Phase II clinical study, designed to evaluate LT3001 drug product versus placebo in subjects with AIS undergoing EVT. Subjects who participate in this trial should be treated with standard of care (SoC) of AIS therapies when appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LT3001 Drug Product | Experimental | Drug: LT3001 Drug ProductAdministered by intravenous infusion |
| Placebo | Placebo comparator | Drug: PlaceboAdministered by intravenous infusion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LT3001 Drug ProductLT3001 Drug Product administered once by intravenous infusion | Drug | LT3001 Drug Product |
| PlaceboPlacebo administered once by intravenous infusion | Drug | Placebo |
Primary outcome
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
Time frame: Within 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LT3001 Drug Product in people with Acute Ischemic Stroke, run by Lumosa Therapeutics Co., Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.