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

## TL;DR

This clinical trial tests a new drug to slow lung function decline in patients with idiopathic pulmonary fibrosis.

## Contribution

The study introduces a phase II trial to evaluate BI 1819479, an LPA pathway inhibitor, as a potential treatment for IPF.

## Key findings

- The trial will assess the drug's efficacy and safety in slowing FVC decline in IPF patients.
- It will determine the optimal dose for future phase III trials.
- Patients will be monitored for up to 52 weeks to evaluate long-term effects.

## Abstract

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.

This study aims to assess BI 1819479, an LPA pathway inhibitor, in patients with IPF (ClinicalTrials.gov Identifier: NCT06335303).

In this placebo-controlled, phase II trial, patients will be randomised (2:1:1:1) to receive one of three 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 end-point is the annual rate of FVC decline (mL·year−1) assessed up to 52 weeks; the secondary end-point is absolute change from baseline in FVC at week 24. Safety will be assessed throughout.

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.

This trial will evaluate the efficacy, safety and dose range of a lysophosphatidic acid pathway inhibitor in patients with IPF, offering potential additional treatment options for patients
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