Clinical Trial to Evaluate the Safety and Efficacy of DWN12088 in Patients With IPF

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis

This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.

This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.

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 expiratory volume in the first second/FVC (FEV1/FVC) ratio ≥0.7 based on pre-bronchodilator value Exclusion Criteria: Acute IPF exacerbation within 6 months prior to screening and/or during the screening period Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study Female patients who are pregnant or nursing Abnormal ECG findings Use of any investigational drugs for IPF within 4 weeks prior to screening