Evaluation of BI 1819479 Efficacy, Safety, and Dose-Response in Idiopathic Pulmonary Fibrosis: A Randomized, Double-Blind, Placebo-Controlled Study

The primary objectives of this study are to demonstrate a non-flat **dose response** curve, evaluate the quantitative treatment effect size, and assess the dose-response relationship of three different doses of BI 1819479 compared to placebo in patients with **idiopathic pulmonary fibrosis**. These objectives are clinically relevant as they aim to establish the optimal dosing strategy for BI 1819479, potentially improving therapeutic outcomes for patients with this progressive lung disease.

The secondary objective is to evaluate the efficacy by comparing the difference in disease progression in terms of **FVC** (Forced Vital Capacity) decline, specifically the absolute change from baseline in FVC at Week 24, for three different doses of BI 1819479 and placebo. This assessment is crucial for understanding the impact of the treatment on lung function over time, providing further insights into its potential benefits in managing idiopathic pulmonary fibrosis.

The clinical trial involves a total of **170 participants** diagnosed with **idiopathic pulmonary fibrosis**. The study population includes both male and female subjects aged **40 years and older**. Participants are required to have a **Forced Vital Capacity (FVC)** of at least 45% of the predicted normal and a **Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)** of at least 25% of the predicted normal, corrected for hemoglobin. The trial includes individuals who are either on stable treatment with nintedanib or pirfenidone for at least 12 weeks or not on treatment with these medications for the same duration. Participants are expected to adhere to specific contraceptive measures if they or their partners are of childbearing potential. The selection process ensures that the trial population is representative of the general demographic affected by the condition, while also considering the stability of their current treatment regimen. The trial does not exclude vulnerable populations, allowing for a comprehensive evaluation of the treatment's efficacy across a diverse group of individuals.

The clinical trial is designed as a **randomized**, **double-blind**, **placebo-controlled** study to evaluate the efficacy, safety, and tolerability of different doses of BI 1819479 in patients with **idiopathic pulmonary fibrosis** (IPF). The trial aims to demonstrate a non-flat dose response curve, evaluate the quantitative treatment effect size, and assess the dose-response relationship of three different doses of BI 1819479 compared to placebo. The study will be conducted over a period of up to 52 weeks, with the primary endpoint being the annual rate of decline in Forced Vital Capacity (FVC) measured in milliliters per year. A secondary endpoint includes the absolute change from baseline in FVC at Week 24.

Participants will be involved in the study for a duration of at least 24 weeks, with the possibility of extending up to 52 weeks depending on the treatment period. The study will commence with an inclusion (screening) visit to confirm eligibility based on criteria such as age, diagnosis of IPF, and stable treatment with nintedanib or pirfenidone. Following the screening, participants will be randomized to receive either BI 1819479 or a matching placebo in the form of a film-coated tablet, administered orally. The trial will include regular follow-up visits to monitor the participants' health status, adherence to the study protocol, and any adverse events. The end-of-study visit will conclude the trial, where final assessments will be conducted to evaluate the outcomes of the treatment.

Participants are expected to adhere to the study protocol, including the use of contraception for women of childbearing potential and male participants with partners of childbearing potential, to prevent exposure to the investigational product. Conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or any adverse events that may compromise the safety of the participant. The trial is not classified as a low-intervention study and is conducted in Phase 4 to investigate the safety and efficacy of the new therapy in patients with IPF.

The clinical trial involves the administration of the experimental medication **BI 1819479**, which is provided in the form of a **film-coated tablet**. This investigational product is of chemical origin and is manufactured by Boehringer Ingelheim International. The active substance in the medication is also named BI 1819479. The route of administration for this medication is oral. The trial is designed to evaluate the efficacy, safety, and tolerability of different doses of BI 1819479 over a treatment period of up to 52 weeks. The specific dosage and frequency of administration are determined by the study protocol, with the aim to assess a non-flat dose response curve and the quantitative treatment effect size.

In addition to the experimental medication, a **placebo** is used in this study. The placebo is a film-coated tablet that matches the experimental medication in size, weight, color, and shape, ensuring blinding in the trial. The placebo does not contain any active substance and serves as a comparator to evaluate the efficacy of BI 1819479. The administration of the placebo follows the same oral route and dosing schedule as the experimental medication, as outlined in the study protocol.

Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the treatment regimen. The study is conducted in a double-blind manner, meaning neither the participants nor the investigators know which treatment the participants are receiving, to maintain the integrity of the trial results.

The efficacy of the investigational product BI 1819479 in the treatment of **idiopathic pulmonary fibrosis (IPF)** will be assessed through a randomized, double-blind, placebo-controlled, dose-finding study. The primary endpoint for evaluating efficacy is the annual rate of decline in Forced Vital Capacity (FVC) measured in milliliters per year, assessed over a treatment period of up to 52 weeks. This parameter will provide insight into the progression of lung function decline in patients receiving the investigational product compared to those receiving a placebo.

Secondary efficacy endpoints include the absolute change from baseline in FVC at Week 24, measured in milliliters. These measurements will be collected at specified time points throughout the study to evaluate the treatment's impact on lung function over time. The study aims to demonstrate a non-flat dose-response curve, evaluate the quantitative treatment effect size, and assess the dose-response relationship of three different doses of BI 1819479 versus placebo. The data collected will be analyzed to determine the efficacy of the investigational product in slowing the progression of IPF.