A Study to Test Whether BI 3810477 Helps People With Idiopathic Pulmonary Fibrosis When Taken With or Without Standard Treatment
Condition(s) studied
Investigational drug(s) / intervention(s)
Placebo: Placebo
BI 3810477: BI 3810477
Study summary
This study is for adults aged 40 and older who have idiopathic pulmonary fibrosis (IPF). Women can only participate if they cannot get pregnant. The purpose of this study is to find out whether a medicine called BI 3810477 can slow down the worsening of lung function in people with IPF.
Participants are put into 2 groups randomly, which means by chance. One group receives BI 3810477 and the other group receives placebo. Placebo looks like BI 3810477 but does not contain any medicine. Participants receive BI 3810477 or placebo for 12 weeks. Participants may continue their regular treatment for IPF during the study.
Participants are in the study for about 6 to 7 months. During this time, they visit the study site regularly, about 18 times. Some of the visits may be done at the participant's home instead of the study site. Doctors regularly test how well the lungs work by doing lung function tests. They also look at lung scans and measure markers in the blood that are linked to lung health. The results are compared between the 2 groups to see whether BI 3810477 works. The doctors also regularly check participants' health and note any unwanted effects.
Eligibility
Primary outcome measure(s)
- Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 12 — At baseline and at Week 12.
Trial sites (37)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arizona | Tucson | Arizona | |
| Yale University School of Medicine | New Haven | Connecticut | |
| Avanza Medical Research Center | Pensacola | Florida | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Mayo Clinic, Rochester | Rochester | Minnesota | |
| Duke University Medical Center | Durham | North Carolina | |
| Cleveland Clinic | Cleveland | Ohio | |
| Clinical Research Associates of Central PA | DuBois | Pennsylvania | |
| Medical University of South Carolina | Charleston | South Carolina | |
| Baylor University Medical Center | Dallas | Texas | |
| University of Utah Health Sciences Center | Salt Lake City | Utah | |
| Centre Hospitalier Universitaire de Liège | Liège | Belgium | |
| Helsinki University Hospital | Helsinki | Finland | |
| Tampere University Hospital | Tampere | Finland | |
| Turku University Hospital / TYKS | Turku | Finland | |
| Universitätsklinikum Aachen, AöR | Aachen | Germany | |
| Vivantes Klinikum Neukölln | Berlin | Germany | |
| Caritas-Krankenhaus St. Maria gGmbH | Donaustauf | Germany | |
| Krankenhaus Bethanien gGmbH | Solingen | Germany | |
| Helios Hanseklinikum Stralsund | Stralstund | Germany | |
| University of Fukui Hospital | Fukui, Yoshida-gun | Japan | |
| National Hospital Organization Kyushu Medical Center | Fukuoka, Fukuoka | Japan | |
| Sapporo Medical University Hospital | Hokkaido, Sapporo | Japan | |
| Kanagawa Cardiovascular and Respiratory Center | Kanagawa, Yokohama | Japan | |
| Saiseikai Kumamoto Hospital | Kumamoto, Kumamoto | Japan | |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Osaka, Sakai | Japan | |
| Hamamatsu University Hospital | Shizuoka, Hamamatsu | Japan | |
| Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas | Distrito Federal | Mexico | |
| Centro de Investigacion Farmacologica del Bajío, S.C. | León | Mexico | |
| Hospital Universitario Nuevo de Nuevo León - CEPREP | Monterrey, Nuevo León | Mexico | |
| Seoul National University Hospital | Seoul | South Korea | |
| Asan Medical Center | Seoul | South Korea | |
| Samsung Medical Center | Seoul | South Korea | |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | |
| Hospital Universitari de Bellvitge | L'Hospitalet Del LLobregat | Spain | |
| Hospital Universitario De La Princesa | Madrid | Spain | |
| Hospital Virgen del Rocio | Seville | Spain |
More Boehringer Ingelheim trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07926321 on ClinicalTrials.gov ↗ ← All trials in Spain