Acute Ischemic StrokePhase 2BRIGHTNCT05403866
A Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 Drug Product in AIS Subjects
A Phase 2 study testing LT3001 Drug Product in people with Acute Ischemic Stroke, run by Lumosa Therapeutics Co., Ltd. at 1 site in United States.
Trial 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) 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
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2022to 23 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 37403
About this study
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)
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)
Read the 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.
- 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
Administered by intravenous infusion
PlaceboDrug
Administered 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 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.
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.
Measured: within 90 days after the first IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start17 Aug 2022
- Primary completion23 May 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 89 participants (actual)
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
- NCT05403866
- Sponsor's protocol ID
- LT3001-205
- Acronym
- BRIGHT
- Status last verified
- Dec 2025
- First submitted
- 31 May 2022
- Last updated
- 26 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05403866
- Acronym / sponsor ID
- BRIGHT / LT3001-205
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Lumosa Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Posted 26 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (6 listed)
- 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.
- 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.
Key exclusion criteria (19 listed)
- 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.
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 ProductAdministered by intravenous infusion | Drug | LT3001 Drug Product |
| PlaceboAdministered by intravenous infusion | Drug | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: 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 1 site in United States.
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 6 inclusion and 19 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: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 26 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 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). 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 26 Dec 2025.