Last updated 5 days ago
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
324 patients around the world
Available in Argentina
This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to
evaluate the efficacy, safety, tolerability, and PK of PIPE-791 in participants with a
diagnosis of Idiopathic Pulmonary Fibrosis with or without background treatment. The
treatment period is 26 weeks and full study duration is up to 36 weeks including
Screening and Follow-Up. Approximately 324 participants will be enrolled into one of
three treatment arms, PIPE-791 Dose A, PIPE-791 Dose B, or placebo.
Contineum Therapeutics
6Research sites
324Patients around the world
This study is for people with
Pulmonary fibrosis
Idiopathic pulmonary fibrosis
Requirements for the patient
From 40 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
STAT Research - CABA
Recruiting
Consultorios Médicos del Buen Ayre
Recruiting
Centro Médico Dra. De Salvo
Recruiting
Ibamédica
Recruiting
Instituto de Investigaciones en Patologías Respiratorias SRL - Tucumán
Recruiting
Centro Modelo de Cardiología SRL - Tucumán
Recruiting
SponsorContineum Therapeutics
Study typeInterventional
Conditions
Idiopathic pulmonary fibrosis
Requirements
From 40 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07284459
