Phase II Study to Assess Safety and Effectiveness of Oral Ifetroban in Adults With Idiopathic Pulmonary Fibrosis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of oral ifetroban in patients with idiopathic pulmonary fibrosis IPF, a condition that causes lung scarring from various causes such as genetics, radiation, or bleomycin treatment. This phase II, multicenter, randomized, placebo-controlled study compares ifetroban to a placebo in adults aged 40 years and older who have confirmed IPF. The study aims to assess ifetrobans ability to prevent and treat lung fibrosis over a 12-month period. Participants will be randomly assigned to receive either 250 mg of oral ifetroban or a matching placebo capsule once daily for 12 months. Patients may continue stable background therapy with antifibrotic agents if applicable. The study includes two groups one receiving ifetroban and the other receiving placebo, with treatments administered daily. Blood and urine samples will be collected to measure both standard and novel biomarkers related to progressive pulmonary fibrosis. Throughout the study, participants will undergo safety and efficacy assessments including lung function tests, quality of life questionnaires, and monitoring for adverse events. Researchers will measure changes in forced vital capacity FVC over 12 months as the primary outcome. Secondary outcomes include time to acute exacerbations, hospitalizations, death, and symptom changes such as dyspnea, cough, and fatigue. Participants health will be regularly monitored via clinical evaluations and laboratory tests to ensure safety and track treatment effects.

Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)