BI 765423 and Standard of Care for Idiopathic Pulmonary Fibrosis
This study is evaluating if the experimental medication BI 765423, when combined with standard of care, can improve lung function in adults with idiopathic pulmonary fibrosis.
BI 765423
+ Placebo
Lung Diseases+2
+ Pulmonary Fibrosis
+ Respiratory Tract Diseases
Treatment Study
Summary
Study start date: November 13, 2025
Actual date on which the first participant was enrolled.This study is focused on adults aged 40 and older who have idiopathic pulmonary fibrosis (IPF), a lung condition that causes scarring and affects breathing. To join, participants must have a specific lung capacity and a certain amount of lung scarring confirmed by a detailed scan. The aim is to see if a new medicine, BI 765423, can help improve lung function in these individuals. The study is important because it hopes to find better treatment options for IPF, a condition with limited therapies currently available, potentially helping those affected to breathe easier and improve their quality of life. Participants are randomly assigned to receive either the BI 765423 medicine or a placebo, which looks like the medicine but has no active ingredients, through a vein infusion every four weeks. They remain in the study for 8 to 10 months, during which they can continue their usual IPF treatments. Throughout the study, participants visit the study site for various tests, including lung function assessments and blood samples, to monitor health and effectiveness of the treatment. Doctors compare results from both groups to determine if the new medicine shows better outcomes and check for any side effects.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.71 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 49 locations
Clinical Trials Center of Middle Tennessee, LLC
Franklin, United StatesThe Prince Charles Hospital
Chermside, AustraliaMedizinische Hochschule Hannover
Hanover, Germany