Condition

Idiopathic Pulmonary Fibrosis

Purpose of the study

This study is to evaluate oral PIPE-791 in subjects with IPF, with or without background antifibrotic treatment. The primary objective is to evaluate efficacy based on change in forced vital capacity (FVC) from baseline to Week 26.

Official Title

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 (IPF)

Who is eligible to participate?

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 2018 ATS/ERS/JRS/ALAT practice guideline as confirmed bythe 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 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) ≤ 30ml/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.

• Women of childbearing potential are not eligible.

• Additional inclusion and exclusion criteria apply.

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane