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

Korábbi kezelés

• 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
• Use of any investigational drugs for IPF within 4 weeks prior to screening

Egyéb

• Female patients who are pregnant or nursing
• Abnormal ECG findings

• 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