About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- DWN12088
- Placebo