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Recruiting NCT07284459

Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 324
Sponsor: Contineum Therapeutics

Location: IPR-Investigaciones en Patologías Respiratorias San Miguel de Tucumán Tucumán Province

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 participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.

Eligibility Criteria

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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. * Female participants must not be of childbearing potential. Additional inclusion and exclusion criteria apply.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07284459). StuddyBuddy aggregates publicly available trial information.