A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in subjects with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.
• Male or female ≥ 40 years of age at the time of Randomization
• A diagnosis of IPF within 7 years prior to Screening, based on the 2018 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT with verification of usual interstitial pneumonia
• Percent predicted (pp) FVC ≥ 40% on Screening spirometry
• Subjects may enter the study whether or not they are receiving background antifibrotic therapy, approved for the treatment of IPF (nintedanib or pirfenidone, but not both concurrently)