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
Condition(s) studied
Investigational drug(s) / intervention(s)
BI 765423: BI 765423
Placebo: Placebo to BI 765423
Study 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
Primary outcome measure(s)
- Absolute change from baseline in FVC (mL) at 12 weeks — Baseline, 12 weeks
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| University of Florida | Gainesville | Florida | |
| Renstar Medical Research | Ocala | Florida | |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| University of Minnesota | Minneapolis | Minnesota | |
| The Lung Research Center, LLC | Chesterfield | Missouri | |
| University of Missouri Health System | Columbia | Missouri | |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | |
| Weill Cornell Medical College | New York | New York | |
| Duke University Medical Center | Durham | North Carolina | |
| University of Cincinnati Medical Center | Cincinnati | Ohio | |
| Temple University | Philadelphia | Pennsylvania | |
| Clinical Trials Center of Middle Tennessee, LLC | Franklin | Tennessee | |
| University of Virginia Health System | Charlottesville | Virginia | |
| The Prince Charles Hospital | Chermside | Queensland | |
| Monash Health | Clayton | Victoria | |
| Institute for Respiratory Health | Nedlands | Western Australia | |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | |
| Yvoir - UNIV UCL de Mont-Godinne | Yvoir | Belgium | |
| Synergy Respiratory Care | Sherwood Park | Alberta | |
| Kelowna Respirology & Allergy Research | Kelowna | British Columbia | |
| QEII Health Sciences Centre | Halifax | Nova Scotia | |
| Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal | Quebec | |
| Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH | Essen | Germany | |
| Medizinische Hochschule Hannover | Hanover | Germany | |
| ASST Papa Giovanni XXIII | Bergamo | Italy | |
| A. O. Universitaria Careggi | Florence | Italy | |
| Azienda Ospedaliera dei Colli | Naples | Italy | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | Italy | |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino | Torino | Italy | |
| Tosei General Hospital | Aichi, Seto | Japan | |
| University of Fukui Hospital | Fukui, Yoshida-gun | Japan | |
| National Hospital Organization Kyushu Medical Center | Fukuoka, Fukuoka | Japan | |
| Kanagawa Cardiovascular and Respiratory Center | Kanagawa, Yokohama | Japan | |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Osaka, Sakai | Japan | |
| Hamamatsu University Hospital | Shizuoka, Hamamatsu | Japan | |
| Soon Chun Hyang University Hospital Bucheon | Bucheon-si, Gyeonggi-do | South Korea | |
| Inje University Haeundae Paik Hospital | Busan | South Korea | |
| Soonchunhyang University Hospital Seoul | Seoul | South Korea |
+ 6 more sites — see the full list on the official registry below.
More Boehringer Ingelheim trials in South Korea
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 NCT07036523 on ClinicalTrials.gov ↗ ← All trials in South Korea