Ischemic StrokePhase 3SP-8203-3001NCT06660719
Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care
A Phase 3 study testing SP-8203 in people with Ischemic Stroke, run by Shin Poong Pharmaceutical Co. Ltd. at 2 sites in South Korea.
Trial summary
This clinical study is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (otaplimastat) and thrombolytic standard of care in acute ischemic stroke patient. As a standard of care, thrombolytic therapy (for instance, recombinant tissue plasminogen activator) will be administered. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- SP-8203
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 852 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 14 Feb 2025to 30 Mar 2027
- Phase
- Phase 3
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with neurologic deficit of ≥ 8 points by National Institute of Health Stroke Scale (NIHSS) score
- Patients with pre-stroke modified Rankin Scale (mRS) must be 0 or 1, which means they were able to carry out all usual duties and activities
- Adults aged ≥19 years and ≤85 years
- Patients who can receive thrombolytic standard of care within 4.5 hours after the onset of early symptoms of acute ischemic stroke
- Patients available for brain Magnetic Resonance Imaging (MRI) scanning
- Patients who consent to participate in this study
Who cannot join
- Patients with systemic allergic diseases or hypersensitivity to specific drugs.
- Patients who were diagnosed with myocardial infarction (MI) within the last 6 months.
- Patients who had arrhythmia causing clinical symptoms such as dyspnea or palpitation within the last 6 months.
- Patients showing the following abnormal ECG findings in stable condition at Emergency Room:
- The range of pulse rate - under 55/min or exceed 120/min
- 2nd or 3rd degree Atrioventricular (AV) block indicated in ECG
Show all 19Show fewer
- Congenital or acquired QT syndrome indicated in ECG
- Pre-excitation syndrome indicated in ECG
- Patients with severe heart failure of New York Heart Association (NYHA) Class III or Class IV.
- Patients with fever (≥ 38℃) or infection signs which require antibiotic therapy at screening.
- Patients with pulmonary diseases (asthma, Chronic Obstruction Pulmonary disease, and active tuberculosis etc.) who have being recently been treated more than 1 month at screening.
- Patients with decreased hemoglobin (Hb< 10g/dL), decreased platelet count (PLT< 100,000/mm3) or hematocrit of <25% in complete blood count.
- Patients who have undergone hemodialysis and/or treatments due to nephropathies, acute or chronic renal failure at screening.
- Patients with a cancer in following conditions: diagnosed within 6 months before the screening time, or any treatment for cancer within the previous 6 months, or with recurrent/ metastatic cancer.
- Pregnant and lactating women. However, Women of Childbearing Potential (WOCBP) can participate in the study only when non-pregnancy is confirmed. Women of Childbearing Potential (WOCBP) is defined as woman who is not definitely menopause and did not receive a surgical contraception.
- Patients who do not consent to use double barrier contraception until 90 days from the first study intervention administration.
- Patients who have participated in other clinical trials of other drugs within the past 3 months. However, if they participated in observational studies and did not take drugs, they can participate in this trial.
- Patients who cannot participate in the study at the discretion of investigators
- Patients who are unable to receive thrombolytic standard of care, rtPA
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Dong-A University Hospital
Busan, 49201
Neurology, +82-31348-9354, 135kbs@shinpoong.co.kr
- Recruiting
Ulsan University Hospital
Ulsan, 44033
Neurology, +82-31348-9354, 135kbs@shinpoong.co.kr
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase III Clinical Study to Evaluate Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Requiring Thrombolytic Therapy as Standard of Care
This clinical study is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (otaplimastat) and thrombolytic standard of care in acute ischemic stroke patient.
As a standard of care, thrombolytic therapy (for instance, recombinant tissue plasminogen activator) will be administered. When reperfusion is not achieved in spite of thrombolytic therapy, endovascular therapy can be performed.
Read the detailed description
Intravenous administration of SP-8203 (otaplimastat), a multipotent neuroprotectant inhibiting matrix metalloprotease activity, significantly reduced infarct volume and recombinant tissue plasminogen activator (rtPA)/ ischemic-induced damage in animal models.
This clinical study is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (otaplimastat) and thrombolytic standard of care in acute ischemic stroke patient.
As a standard of care, thrombolytic therapy (for instance, recombinant tissue plasminogen activator) will be administered. When reperfusion is not achieved in spite of thrombolytic therapy, endovascular therapy can be performed.
A total of 852 participants will be enrolled in double-blind, randomized and parallel design with 426 participants assigned to 80 mg/day SP-8203 arm or placebo arm, respectively.
Eligible participants are the patients with neurologic deficit of ≥8 point on National Institute of Health Stroke Scale (NIHSS) score. The participant will receive the study intervention a total of 6 times, with 12 hours intervals. Imaging test will be performed using validated machine and method. The participant will have initial brain Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA) performed within 6 hours before or after the administration of study intervention, and brain Computed Tomography (CT) will be performed at 24±3 hours after completion of the first administration of study intervention.
Brain Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA) will be followed-up on Day 5, and additionally the participant will undergo additional functional and neurological evaluations for up to 90 days.
When unexpected serious adverse reaction occurs during the clinical study, Data Safety Monitoring Board (DSMB) will be convened to validation safety.
- Conditions
- Ischemic Stroke
- Being tested
- SP-8203, Placebo
- Keywords
- SP-8203 (Otaplimastat), rtPA (recombinant tissue Plasminogen Activator), Thrombolytic therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-8203Drug
Also called Otaplimastat (SP-8203)
SP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours)
PlaceboDrug
Placebo will be intravenously administered twice daily (intervals of 12 hours)
| Study group | Role | What they receive |
|---|---|---|
| SP-8203 | Experimental | SP-8203 80 mg (40 mg/dose twice a day for three days) Receives: Drug: SP-8203 |
| Placebo | Placebo comparator | Placebo group: twice a day for three days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with modified Rankin Scale (mRS) 0-1
Proportion of participants with modified Rankin Scale (mRS) 0-1 at Day 90 in patients with acute ischemic stroke requiring thrombolytic standard of care
Measured: Day 90
Secondary outcomes (10)
Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan
Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan performed at 24±3 hours in accordance with European Cooperative Acute Stroke Study (ECASS) I and II criteria, after the administration of SP-8203 in conjunction with thrombolytic standard of care
Measured: Day 1
Proportion of participants with modified Rankin Scale (mRS) 0-1
Proportion of participants with modified Rankin Scale (mRS) 0-1 at Day 30 in patients with acute ischemic stroke requiring thrombolytic standard of care
Measured: Day 30
Proportion of participants with modified Rankin Scale (mRS) 0-2
Proportion of participants with modified Rankin Scale (mRS) 0-2 at Day 30 and Day 90 in the patients with acute ischemic stroke requiring thrombolytic standard of care
Measured: Day 30 and Day 90
Change from Baseline in National Institute of Health Stroke Scale (NIHSS) scores
The change in the National Institute of Health Stroke Scale (NIHSS) scores until 90 day in subjects with acute ischemic stroke requiring rtPA standard of care. The maximum total score is 42 points, which indicates the most critical condition and the minimum total score is 0, which indicates no neurologic deficit.
Measured: Day 0 (baseline), Day 3, Day 5, Day 30 and Day 90
Fold change in infarct growth classified by modified treatment in cerebral ischemia (mTICI) grade within 5 days
MRI (DWI) imaging outcomes
Measured: Day 5
The incidence of serious adverse events
The incidence of serious adverse events
Measured: follow-up to 90 days after the first study intervention administration
The rate of death
The rate of death due to any cause
Measured: follow-up to 90 days after the first study intervention administration
The incidence rate of adverse events, and adverse drug reaction
The incidence rate of adverse events, and adverse drug reaction
Measured: follow-up to 90 days after the first study intervention administration
The incidence of symptomatic Intracranial Hemorrhage (sICH)
The incidence of symptomatic Intracranial Hemorrhage (sICH) occurring within 5 days of administration according to the definition described on the protocol
Measured: within 5 days from the first study intervention administration
The Incidence of major systemic bleeding
The Incidence of major systemic bleeding according to the International Society of Thrombosis and Hemostasis (ISTH) definition
Measured: within 5 days after the first study intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start14 Feb 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 852 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jong Sung Kim, MD, Phd, Study chair, GangNeung Asan Medical CenterBeom Jun Kim, MD, Phd, Principal investigator, Seoul Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660719
- Sponsor's protocol ID
- SP-8203-3001
- Acronym
- SP-8203-3001
- Status last verified
- Mar 2025
- First submitted
- 25 Oct 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase III Clinical Study to Evaluate Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Requiring Thrombolytic Therapy as Standard of Care
- ClinicalTrials.gov ID
- NCT06660719
- Acronym / sponsor ID
- SP-8203-3001 / SP-8203-3001
- Conditions
- Ischemic Stroke
- Keywords
- SP-8203 (Otaplimastat), rtPA (recombinant tissue Plasminogen Activator), Thrombolytic therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 852 participants (estimated)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 28 Oct 2024 (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.
This clinical study is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (otaplimastat) and thrombolytic standard of care in acute ischemic stroke patient.
As a standard of care, thrombolytic therapy (for instance, recombinant tissue plasminogen activator) will be administered. When reperfusion is not achieved in spite of thrombolytic therapy, endovascular therapy can be performed.
Detailed description
Intravenous administration of SP-8203 (otaplimastat), a multipotent neuroprotectant inhibiting matrix metalloprotease activity, significantly reduced infarct volume and recombinant tissue plasminogen activator (rtPA)/ ischemic-induced damage in animal models.
This clinical study is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (otaplimastat) and thrombolytic standard of care in acute ischemic stroke patient.
As a standard of care, thrombolytic therapy (for instance, recombinant tissue plasminogen activator) will be administered. When reperfusion is not achieved in spite of thrombolytic therapy, endovascular therapy can be performed.
A total of 852 participants will be enrolled in double-blind, randomized and parallel design with 426 participants assigned to 80 mg/day SP-8203 arm or placebo arm, respectively.
Eligible participants are the patients with neurologic deficit of ≥8 point on National Institute of Health Stroke Scale (NIHSS) score. The participant will receive the study intervention a total of 6 times, with 12 hours intervals. Imaging test will be performed using validated machine and method. The participant will have initial brain Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA) performed within 6 hours before or after the administration of study intervention, and brain Computed Tomography (CT) will be performed at 24±3 hours after completion of the first administration of study intervention.
Brain Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA) will be followed-up on Day 5, and additionally the participant will undergo additional functional and neurological evaluations for up to 90 days.
When unexpected serious adverse reaction occurs during the clinical study, Data Safety Monitoring Board (DSMB) will be convened to validation safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP-8203 | Experimental | Drug: SP-8203SP-8203 80 mg (40 mg/dose twice a day for three days) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group: twice a day for three days |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with neurologic deficit of ≥ 8 points by National Institute of Health Stroke Scale (NIHSS) score
- Patients with pre-stroke modified Rankin Scale (mRS) must be 0 or 1, which means they were able to carry out all usual duties and activities
- Adults aged ≥19 years and ≤85 years
- Patients who can receive thrombolytic standard of care within 4.5 hours after the onset of early symptoms of acute ischemic stroke
- Patients available for brain Magnetic Resonance Imaging (MRI) scanning
Key exclusion criteria (19 listed)
- Patients with systemic allergic diseases or hypersensitivity to specific drugs.
- Patients who were diagnosed with myocardial infarction (MI) within the last 6 months.
- Patients who had arrhythmia causing clinical symptoms such as dyspnea or palpitation within the last 6 months.
- Patients showing the following abnormal ECG findings in stable condition at Emergency Room:
- Patients with severe heart failure of New York Heart Association (NYHA) Class III or Class IV.
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 |
|---|---|---|
| SP-8203Also: Otaplimastat (SP-8203)SP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours) | Drug | SP-8203 |
| PlaceboPlacebo will be intravenously administered twice daily (intervals of 12 hours) | Drug | Placebo |
Primary outcome
Proportion of participants with modified Rankin Scale (mRS) 0-1
Time frame: Day 90
Proportion of participants with modified Rankin Scale (mRS) 0-1 at Day 90 in patients with acute ischemic stroke requiring thrombolytic standard of care
10 secondary outcomes
Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan
Time frame: Day 1
Proportion of participants with modified Rankin Scale (mRS) 0-1
Time frame: Day 30
Proportion of participants with modified Rankin Scale (mRS) 0-2
Time frame: Day 30 and Day 90
Change from Baseline in National Institute of Health Stroke Scale (NIHSS) scores
Time frame: Day 0 (baseline), Day 3, Day 5, Day 30 and Day 90
Fold change in infarct growth classified by modified treatment in cerebral ischemia (mTICI) grade within 5 days
Time frame: Day 5
The incidence of serious adverse events
Time frame: follow-up to 90 days after the first study intervention administration
The rate of death
Time frame: follow-up to 90 days after the first study intervention administration
The incidence rate of adverse events, and adverse drug reaction
Time frame: follow-up to 90 days after the first study intervention administration
The incidence of symptomatic Intracranial Hemorrhage (sICH)
Time frame: within 5 days from the first study intervention administration
The Incidence of major systemic bleeding
Time frame: within 5 days after the first study intervention administration
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 7 Mar 2025.
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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.
Jong Sung Kim, MD, Phd study chair
GangNeung Asan Medical Center
Beom Jun Kim, MD, Phd principal investigator
Seoul Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SP-8203 in people with Ischemic Stroke, run by Shin Poong Pharmaceutical Co. Ltd. at 2 sites in South Korea.
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: looking for participants now, as of the sponsor's last update on 7 Mar 2025. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Jong Sung Kim, MD, Phd (+82-33-610-3114, jongskim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with modified Rankin Scale (mRS) 0-1 (time frame: Day 90). 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 7 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.