Acute Ischemic StrokePhase 2NCT07890298
A Study to Evaluate the Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in AIS Participant
A Phase 2 study testing LT3001 Drug Product in people with Acute Ischemic Stroke, run by Lumosa Therapeutics Co., Ltd. at 1 site in Taiwan.
Trial summary
This is a phase II, open-label, single-arm, exploratory study to evaluate the intracranial arterial recanalization of multiple doses of LT3001 drug product in participant with acute ischemic stroke (AIS) Read more about this study
- Who is it for?
- Ages 18 to 88 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?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2026to Jun 2028
- Phase
- Phase 2
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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant or participant's legal representative consents to participation by signing the informed consent form (ICF) after receiving full information about the study.
- Participant is aged 18 to 88 years, inclusive, at the time of Screening (Visit 1).
- Participant is not to be treated with intravenous thrombolytic (e.g., recombinant tissue-type plasminogen activator) treatment or endovascular thrombectomy (EVT)
- Participant has NIHSS of 6 to 23.
- Participant is able to receive the 1st IP within 24 hours after stroke symptoms onset.
- Participants 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 last dosing of IP. A female participant is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
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- Neuroimaging Inclusion Criteria:
- Participant is willing and able to undergo brain computed tomography angiography (CTA) or magnetic resonance angiography (MRA).
- No known history of severe contrast allergy, anaphylactoid reaction, or other clinical conditions that contraindicate contrast agent administration for CTA or MRA
- Must not have MRI contraindications such as non-MRI-compatible pacemakers, cochlear implants, ferromagnetic implants/devices, claustrophobia, or other conditions preventing safe MRI scanning
- Participant is confirmed to have an acute intracranial arterial occlusion.
Who cannot join
- Participant has a pre-stroke disability that requires help for activities of daily living (mRS >2).
- Participant has Alberta Stroke Program Early CT Score (ASPECTS) of <5.
- Participant has AOL =3 at Screening (Visit 1).
- Participant has symptoms of suspected subarachnoid hemorrhage, even if CT is normal.
- Participant 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.
- Participant has significant mass effect with midline shift.
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- Participant 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.
- Participant has current uncontrolled hypertension despite treatment: systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg before dosing at Screening (Visit 1).
- Participant 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).
- Participant has received one of the new oral anticoagulants within 48 hours before the 1st IP administration, e.g., dabigatran, apixaban, rivaroxaban, and edoxaban, except for dabigatran-treated participant who has been given a reversal agent, idarucizumab, before the 1st IP administration.
- Participant has platelet count <100,000/mm3 at Screening (Visit 1).
- Participant has blood glucose concentration <50 mg/dL or >400 mg/dL at Screening (Visit 1).
- Participant has moderate or severe hepatic, renal, and/or active infectious disease at Screening (Visit 1) as judged by the investigator. Participant with confirmed COVID-19 or influenza infection can be enrolled at the Investigator's discretion.
- Participant is lactating, pregnant (pregnancy test required for all female participants of childbearing potential), or planning to become pregnant during the study.
- Participant has history of sICH, prior AIS, myocardial infarction, serious head trauma, or any major surgery within 90 days before Screening (Visit 1).
- Participant has had a bleeding event within 21 days before Screening (Visit 1), e.g., gastrointestinal hemorrhage.
- Participant has puncture of noncompressible vessels within 7 days before Screening (Visit 1).
- Participant has participated in another investigational study and received investigational product within 30 days before Screening (Visit 1) or 5 half-lives (whichever is longer).
- In the opinion of the Investigator, the participant has serious, advanced, or terminal illness that will prevent improvement or follow-up visits.
- In the opinion of the Investigator, the participant is not appropriate for the study for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Medical University, Taichung
Taichung
Claire Sun, +886-2-2655-7918, claire_sun@lumosa.com.tw
About this study
Official title: An Open-Label, Single-Arm, Exploratory Study to Evaluate Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in Participants With Acute Ischemic Stroke (AIS)
This is a phase II, open-label, single-arm, exploratory study to evaluate the intracranial arterial recanalization of multiple doses of LT3001 drug product in participant with acute ischemic stroke (AIS)
Read the detailed description
This is a multicenter, open-labeled, prospective Phase II clinical study, designed to evaluate the effect of the intracranial arterial recanalization in AIS participant receiving LT3001 drug product. The study is planned to take place in multiple sites. Subjects who participate in this trial should be treated with standard of care of AIS therapies when appropriate.
- Conditions
- Acute Ischemic Stroke
- Being tested
- LT3001 Drug Product
- 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
Administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| LT3001 Drug Product | Experimental | Administered by intravenous infusion Receives: Drug: LT3001 Drug Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful recanalization at 24 hours after the 1st IP. Successful recanalization is defined as any improvement in Arterial Occlusive Lesion (AOL) score.
After administer the 1st IP, successful recanalization at 24 hours will be assessed by AOL score and the rate of successful recanalization will be calculated. The Arterial Occlusive Lesion (AOL) score is a 4-point angiographic grading scale (scored 0 to 3) used to measure the degree of recanalization (restoration of blood flow through the blocked target artery) in patients with acute ischemic stroke. Successful recanalization is defined as any improvement in AOL score.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completionJun 2028 (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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT07890298
- Sponsor's protocol ID
- LT3001-206
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No