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

NCT06660719 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: SP-8203-3001
• Study Type: interventional
• Target: 852
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ischemic Stroke

Keywords

SP-8203 (Otaplimastat); rtPA (recombinant tissue Plasminogen Activator); Thrombolytic therapy

Outcome Measures

Primary Outcomes (1)

• 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

  Day 90

Secondary Outcomes (10)

• Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan

  Day 1

• Proportion of participants with modified Rankin Scale (mRS) 0-1

  Day 30

• Proportion of participants with modified Rankin Scale (mRS) 0-2

  Day 30 and Day 90

• Change from Baseline in National Institute of Health Stroke Scale (NIHSS) scores

  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

  Day 5

Study Arms (2)

SP-8203

EXPERIMENTAL

SP-8203 80 mg (40 mg/dose twice a day for three days)

Drug: SP-8203

Placebo

PLACEBO COMPARATOR

Placebo group: twice a day for three days

Drug: Placebo

Interventions

SP-8203 DRUG

SP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours)

Also known as: Otaplimastat (SP-8203)

SP-8203

Placebo DRUG

Placebo will be intravenously administered twice daily (intervals of 12 hours)

Placebo

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• nd 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 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.

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (2)

Dong-A University Hospital

Busan, 49201, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, 44033, South Korea

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

otaplimastat

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jong Sung Kim, MD, Phd

  GangNeung Asan Medical Center

  STUDY CHAIR

• Beom Jun Kim, MD, Phd

  Seoul Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong Sung Kim, MD, Phd

CONTACT

+82-33-610-3114; jongskim@amc.seoul.kr

Byung Su Kim, MS

CONTACT

+82-70-5168-6503; 135kbs@shinpoong.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: February 14, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

KR (2)