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 (NCT07284459)

This is a Phase 2, randomized, double-blind, placebo-controlled, global multicenter study to evaluate the efficacy, safety, tolerability, and PK of PIPE-791 in subjects with a clinical diagnosis of IPF with or without background antifibrotic treatment.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

A/Prof Ian Glaspole

Key inclusion data

INCLUSION: ≥40 years of age prior to screening; >40kgs; IPF diagnosis ≤7 years prior to screening; FVCpp≥40%; DLCOpp (Hemoglobin-adjusted) ≥ 25% to < 80%; Current treatment for IPF with background therapy is allowed, if at a stable dose for 3mths prior to screening /or no AF treatment okay. EXCLUSION: Acute IPF exacerbation 6 months prior to screening; Receiving pharmacological therapy for pulmonary hypertension; FEV1/FVC ratio <0.7 at screening; Active infection or any condition that prevents correct assessment of spirometry performance; Surgical procedure(s) planned to occur during the study period; Extent of emphysema > 50 % or that is greater than the extent of fibrotic changes on the most recent HRCT scan; Patient with PAH on multi-drug therapy; Unstable cardiac disease; BP S< 105/ seated.