SB17170 Phase 2 Trial in IPF Patients

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: IPF, Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)

In brief

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.

Key facts

Study ID

NCT06747923

Run by

SPARK Biopharma

People needed

30

Starts

2025-01-27

Expected to finish

2026-10-31

Last updated by the study team

2025-11-19

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male/female 40 years or older at the time of obtaining informed consent
• 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
• Patients with a history of idiopathic pulmonary fibrosis treatment who meet the defined criteria
• Patients with Forced Vital Capacity (FVC) ≥ 45% of the normal predicted value at the screening visit
• Patients meeting pulmonary function test criteria at the screening visit
• Patients who have received the explanation of this clinical trial and voluntarily agreed and signed the informed consent form

You may not qualify if…

• 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
• Patients with confirmed acute exacerbation of IPF within 6 months prior to screening and/or during the screening period
• Patients with lower respiratory tract infections requiring antibiotic treatment
• Patients who underwent major surgery within 3 months before screening or have major surgery planned during the clinical trial
• Patients with a history of malignancy or documented evidence of active or suspected malignancy within 5 years prior to screening
• Patients with evidence of active infection
• 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
• Patients with pulmonary hypertension
• 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
• Patients with Human Immunodeficiency Virus (HIV) infection or active hepatitis B or C

Where it is running

• Myong Ji Hospital — Goyang, South Korea (enrolling)
• Chung-Ang University Gwangmyeong Hospital — Gwangmyeong, South Korea (enrolling)
• Seoul Asan Hospital — Seoul, South Korea
• The Catholic Univ. of Korea Seoul St. Mary's Hospital — Seoul, South Korea
• Ajou University Hospital — Suwon, South Korea

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.