Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
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
Contineum Therapeutics
324 participants
Jan 8, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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)
Exclusion Criteria4
- 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.
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Interventions
Subjects will receive a daily oral dose of PIPE-791 in tablet form
Subjects will receive a daily oral dose of PIPE-791 in tablet form
Subjects will receive a daily oral dose of matching Placebo in tablet form
Locations(22)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07284459