SB17170 Phase 2 Trial in IPF Patients

Idiopathic pulmonary fibrosis (IPF) is a progressive respiratory disease characterized by a scarring process of the lung, bringing patients to respiratory failure and death in 3-5 years from diagnosis.

Subjects who meet the inclusion/exclusion criteria as a result of the screening test shall be randomized into Test Group 1 (SB17170 A mg), Test Group 2 (SB17170 B mg) and Control Group (Placebo for SB17170) in 2:2:1. Subjects who have been randomized will orally take 2 capsules once daily after a meal according to their assigned administration group for 12 weeks from the date they are prescribed the investigational product.

Safety and tolerability at 12 weeks after randomization, and efficacy at 4 & 12 weeks will be assessed. The subject who has completed 12 weeks of treatment shall visit the trial site after 1 week (Visit 7, EOS) for a follow-up.

Inclusion criteria

• 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

Exclusion criteria

• 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