Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF
Trial Parameters
Brief Summary
This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
Eligibility Criteria
Inclusion Criteria: * Male or female patients aged ≥40 years based on the date of the written informed consent form * Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines * In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation * Patients receiving local standard-of-care for IPF, defined as either pirfenidone or nintedanib, at a stable dose for at least 3 months prior to screening, or neither pirfenidone nor nintedanib. If the patients were on pirfenidone or nintedanib previously and have been off for at least 3 months prior to screening, they will be considered as not on any treatment for IPF * Meeting all of the following criteria during the screening period: * FVC ≥40% predicted of normal * DLCO corrected for Hgb ≥25% and ≤80% predicted of normal. * forced ex