Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care

Last updated: March 4, 2025
Sponsor: Shin Poong Pharmaceutical Co. Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Blood Clots

Occlusions

Stroke

Treatment

SP-8203

Placebo

Clinical Study ID

NCT06660719
SP-8203-3001
  • Ages 19-85
  • All Genders

Study 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. When reperfusion is not achieved in spite of thrombolytic therapy, endovascular therapy can be performed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with neurologic deficit of ≥ 8 points by National Institute of HealthStroke Scale (NIHSS) score

  • Patients with pre-stroke modified Rankin Scale (mRS) must be 0 or 1, which meansthey 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 theonset of early symptoms of acute ischemic stroke

  • Patients available for brain Magnetic Resonance Imaging (MRI) scanning

  • Patients who consent to participate in this study

Exclusion

Exclusion Criteria:

  • Patients with systemic allergic diseases or hypersensitivity to specific drugs.

  • Patients who were diagnosed with myocardial infarction (MI) within the last 6months.

  • Patients who had arrhythmia causing clinical symptoms such as dyspnea or palpitationwithin the last 6 months.

  • Patients showing the following abnormal ECG findings in stable condition atEmergency Room:

  • The range of pulse rate - under 55/min or exceed 120/min

  • 2nd or 3rd degree Atrioventricular (AV) block indicated in ECG

  • 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 orClass IV.

  • Patients with fever (≥ 38℃) or infection signs which require antibiotic therapy atscreening.

  • Patients with pulmonary diseases (asthma, Chronic Obstruction Pulmonary disease, andactive tuberculosis etc.) who have being recently been treated more than 1 month atscreening.

  • 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 thescreening time, or any treatment for cancer within the previous 6 months, or withrecurrent/ metastatic cancer.

  • Pregnant and lactating women. However, Women of Childbearing Potential (WOCBP) canparticipate in the study only when non-pregnancy is confirmed. Women of ChildbearingPotential (WOCBP) is defined as woman who is not definitely menopause and did notreceive a surgical contraception.

  • Patients who do not consent to use double barrier contraception until 90 days fromthe first study intervention administration.

  • Patients who have participated in other clinical trials of other drugs within thepast 3 months. However, if they participated in observational studies and did nottake 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

Study Design

Total Participants: 852
Treatment Group(s): 2
Primary Treatment: SP-8203
Phase: 3
Study Start date:
February 14, 2025
Estimated Completion Date:
March 30, 2027

Study 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.

Connect with a study center

  • Dong-A University Hospital

    Busan, 49201
    Korea, Republic of

    Active - Recruiting

  • Ulsan University Hospital

    Ulsan, 44033
    Korea, Republic of

    Active - Recruiting

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