Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Korábbi kezelés

• Acute IPF exacerbation within 4 months prior to Visit 1 and/or during the screening period, as determined by the investigator
• Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study

Egyéb

• Female patients who are pregnant or nursing
• Abnormal ECG findings
  • Other protocol inclusion and exclusion criteria may apply.

• 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
• Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for > 8 weeks prior to Visit 1
• 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