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 participants 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 2022 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual interstitial pneumonia (UIP) or probable UIP.
Percent predicted (pp) FVC ≥ 40% on Screening spirometry.
Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy approved for the treatment of IPF, but not both concurrently.
Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.
Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible.
Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible.
Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible.
Contineum Therapeutics
Lead sponsor