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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• IPR-Investigaciones en Patologías Respiratorias, San Miguel de Tucumán, Tucumán Province, Argentina
• Centro Modelo de Cardiología-Laprida 554, San Miguel de Tucumán, Tucumán Province, Argentina
• STAT Research S.A., Buenos Aires, Argentina
• Consultorios Médicos Organización del Buen Ayre SRL, Buenos Aires, Argentina
• Centro Médico Dra de Salvo - Fundacion Respirar - PPDS, Buenos Aires, Argentina
• IbaMedica, Santa Fe, Argentina
• Westmead Hospital, Westmead, New South Wales, Australia
• The Prince Charles Hospital, Chermside, Queensland, Australia
• Austin Health, Heidelberg, Victoria, Australia
• The Alfred Hospital, Melbourne, Victoria, Australia
• Institute for Respiratory Health, Midland, Western Australia, Australia
• TrialsWest Pty Ltd, Spearwood, Western Australia, Australia

+ 36 more sites.

Who to contact

Nikki Nepomuceno · 858-333-5280 · nnepomuceno@contineum-tx.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07284459.