This is a randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
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
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
Parallel
DWN12088
DrugDWN12088 Xmg Tablet (BID)
Placebo
DrugPlacebo 0mg Tablet (BID)
Rate of decline of FVC
To investigate the efficacy of DWN12088 on pulmonary function
Incidents of treatment-emergent adverse events
To evaluate the safety and tolerability of DWN12088 compared with placebo
Time to progression of IPF
To evaluate the efficacy of DWN12088 on time to progression of IPF
Quantitative high-resolution computed tomography
To evaluate the efficacy of DWN12088 as measured by quantitative high-resolution computed tomography
Functional exercise capacity, assessed by the 6-minute walk test (6MWT) distance
To evaluate the efficacy of DWN12088 on functional exercise capacity, assessed by 6MWT distance
Diffusing capacity of lung for carbon monoxide (DLCO) corrected for Hgb
To evaluate the efficacy of DWN12088 on pulmonary diffusion function
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