- Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis — Recruiting • Phase II • Respiratory / COPD / Asthma • NCT07284459.
- What is being tested: PIPE-791, a novel investigational agent, is being evaluated in a Phase 2 randomised controlled trial to assess its efficacy, safety, tolerability, and pharmacokinetics in patients with Idiopathic Pulmonary Fibrosis (IPF), including those on concurrent standard therapies.
- Patient eligibility overview: The trial enrolls adults with a confirmed diagnosis of IPF, with flexibility to include patients regardless of whether they are currently receiving background treatment, allowing evaluation across a representative disease population.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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 subjects with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.
- 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 2018 ATS/ERS/JRS/ALAT practice guideline as confirmed by the 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) Key
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.