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Keep this study
Lead
Daewoong Pharmaceutical Co. LTD.
This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary Fibrosis.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
