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Clinical Trials in South Korea / NCT06747923
Recruiting Phase 2

SB17170 Phase 2 Trial in IPF Patients

NCT06747923 · tracked via the Priya Life Science South Korea tracker
Sponsor
SPARK Biopharma
Phase
Phase 2
Started
2025-01-27
Last updated
2025-11-19

Condition(s) studied

IPFIdiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)

Investigational drug(s) / intervention(s)

SB17170 →Placebo

SB17170: Taking SB17170 orally once a day

Placebo: Taking Placebo orally once a day

Study summary

This clinical trial is a 2:2:1 randomized, double-blind, placebo-controlled, parallel group, exploratory phase II trial. The main objective of this trial is to compare and evaluate change in FVC compared to placebo by administering SB17170 to moderate to severe patients with IPF. This clinical trial treatment involves administering SB17170 or placebo for 12 weeks.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adult male/female 40 years or older at the time of obtaining informed consent 2. Patients diagnosed with idiopathic pulmonary fibrosis who meet the following criteria: * Patients with idiopathic pulmonary fibrosis who are confirmed by chest High-Resolution Computed Tomography (HRCT) scan * Patients with Usual Interstitial Pneumonia (UIP) or probable UIP HRCT pattern consistent with a diagnosis of idiopathic pulmonary fibrosis confirmed through central reading of chest HRCT before the baseline visit 3. Patients with a history of idiopathic pulmonary fibrosis treatment who meet the defined criteria 4. Patients with Forced Vital Capacity (FVC) ≥ 45% of the normal predicted value at the screening visit 5. Patients meeting pulmonary function test criteria at the screening visit 6. Patients who have received the explanation of this clinical trial and voluntarily agreed and signed the informed consent form Exclusion Criteria: 1. When there is a primary disease showing UIP patterns (rheumatoid arthritis-related interstitial lung disease, connective tissue disease-related interstitial lung disease, etc.) and/or other clinically significant lung abnormalities 2. Patients with confirmed acute exacerbation of IPF within 6 months prior to screening and/or during the screening period 3. Patients with lower respiratory tract infections requiring antibiotic treatment 4. Patients who underwent major surgery within 3 months before screening or have major surgery planned during the clinical trial 5. Patients with a history of malignancy or documented evidence of active or suspected malignancy within 5 years prior to screening 6. Patients with evidence of active infection 7. Patients with the following cardiovascular and cerebrovascular diseases at the time of screening: * Severe hypertension within 3 months * Myocardial infarction or unstable angina within 6 months * History of thrombotic events within 6 months * Diagnosis of heart failure within 6 months 8. Patients with pulmonary hypertension 9. Patients who are unable to take drugs orally or have a history of major gastrointestinal surgery or pathological findings that may affect the absorption of the investigational product 10. Patients with Human Immunodeficiency Virus (HIV) infection or active hepatitis B or C

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Myong Ji Hospital Goyang South Korea Recruiting
Chung-Ang University Gwangmyeong Hospital Gwangmyeong South Korea Recruiting
Seoul Asan Hospital Seoul South Korea Not Yet Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital Seoul South Korea Not Yet Recruiting
Ajou University Hospital Suwon South Korea Not Yet Recruiting

More SPARK Biopharma trials in South Korea

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06747923 on ClinicalTrials.gov ↗ ← All trials in South Korea