Design of a Phase II randomised, double-blind, placebo-controlled, dose-finding trial of BI 1819479 in patients with idiopathic pulmonary fibrosis

Background Current treatments for idiopathic pulmonary fibrosis (IPF) slow but do not stop/reverse disease progression. The lysophosphatidic acid (LPA) axis is identified as a therapeutic target for IPF. Objective: This study aims to assess BI 1819479, a lysophosphatidic acid (LPA) pathway inhibitor, in patients with IPF (ClinicalTrials.gov; NCT06335303 ). Methods In this placebo-controlled, Phase II trial, patients will be randomised (2:1:1:1) to receive 1 of 3 oral doses of BI 1819479 or placebo, stratified by nintedanib/pirfenidone use. Patients aged ≥40 years with IPF, forced vital capacity (FVC) ≥45% of predicted normal and haemoglobin-corrected diffusing capacity for carbon monoxide ≥25% of predicted normal at screening will be included. Patients with relevant airway obstruction (pre-bronchodilator forced expiratory volume in 1 s/FVC <0.7), acute IPF exacerbation ≤12 weeks prior to screening, treatment with immunosuppressive medications (other than oral corticosteroids) or prednisone >15 mg·day −1 or equivalent, will be excluded. Treatment with approved IPF treatments (nintedanib/pirfenidone) is allowed if at a stable dose for ≥12 weeks prior to trial entry. Patients will be treated until completing 52 weeks, or 24 weeks after the last patient is randomised, whichever occurs first. The primary endpoint is the annual rate of FVC decline (mL/year) assessed up to 52 weeks; the secondary endpoint is absolute change from baseline in FVC at Week 24. Safety will be assessed throughout. Conclusion This trial evaluates the efficacy, safety and dose range of BI 1819479 in patients with IPF, offering a potential additional treatment option, and will establish appropriate dosing for Phase III trials.