A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment
Start Date
11/13/2025
Completion Date
6/22/2027
Summary
This study is open to adults who are at least 40 years old and have idiopathic pulmonary fibrosis (IPF). People can participate in the study if they have a forced vital capacity (FVC) greater than or equal to 45% of the predicted value and fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan. The purpose of this study is to find out if a medicine called BI 765423 can improve lung function in people with IPF. The study will compare BI 765423 with a placebo to see if there is a difference in lung capacity after 3-6 months of treatment and will also look at changes in certain markers related to lung health. Participants are put into two groups randomly, which means by chance. One group receives the study medicine, and the other group receives a placebo. Placebo looks like BI 765423 but does not contain any study medicine. The study medicine is given as an infusion into a vein every four weeks. Participants are in the study for up to 11 months. During the study, participants may continue their regular treatment for IPF. During the study they visit the study site several times for screening, treatment, and follow-up. Doctors regularly test lung function by measuring FVC and take blood samples to measure study endpoints. The results are compared between the two groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.
Eligibility Criteria
Age Range: 40 years to No maximum
Interventions
BI 765423
Placebo
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
United States
University of Florida
Gainesville, Florida 32610
United States
Renstar Medical Research
Ocala, Florida 34470
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United States
University of Kansas Medical Center
Kansas City, Kansas 66103-2937
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
The Lung Research Center, LLC
Chesterfield, Missouri 63017
United States
University of Missouri Health System
Columbia, Missouri 65212
United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York 10032
United States
Weill Cornell Medical College
New York, New York 10065
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45267
United States
Temple University
Philadelphia, Pennsylvania 19140
United States
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee 37067
United States
University of Virginia Health System
Charlottesville, Virginia 22903
United States
The Prince Charles Hospital
Chermside, Queensland 4032
Australia
Monash Health
Clayton, Victoria 3168
Australia
Institute for Respiratory Health
Nedlands, Western Australia 6009
Australia
Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, 5530
Belgium
Synergy Respiratory Care
Sherwood Park, Alberta T8H 0N2
Canada
Kelowna Respirology & Allergy Research
Kelowna, British Columbia V1Y 3H5
Canada
QEII Health Sciences Centre
Halifax, Nova Scotia B3H 3A7
Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X 0A9
Canada
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
Germany
Medizinische Hochschule Hannover
Hanover, 30625
Germany
ASST Papa Giovanni XXIII
Bergamo, 24127
Italy
A. O. Universitaria Careggi
Florence, 50137
Italy
Azienda Ospedaliera dei Colli
Naples, 80131
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Italy
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Torino, 10126
Italy
Tosei General Hospital
Aichi, Seto, 489-8642
Japan
University of Fukui Hospital
Fukui, Yoshida-gun, 910-1193
Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563
Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051
Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555
Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192
Japan
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, 14584
South Korea
Inje University Haeundae Paik Hospital
Busan, 48108
South Korea
Soonchunhyang University Hospital Seoul
Seoul, 04401
South Korea
Hospital Vall Hebron
Barcelona, 08035
Spain
Hospital Universitari de Bellvitge
L Hospitalet Del Llobregat, 08907
Spain
Hospital Universitario De La Princesa
Madrid, 08035
Spain
Hospital Virgen del Rocío
Seville, 41013
Spain
Cantonal Hospital of Aarau
Aarau, 5001
Switzerland
Universitätsspital Basel
Basel, 4031
Switzerland