Actively Recruiting
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
Led by Boehringer Ingelheim · Updated on 2026-05-13
71
Participants Needed
47
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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 8-10 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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 40 years of age or older at the time of informed consent signature
- Signed and dated written informed consent according to ICH-GCP and local laws prior to trial admission
- Male or female patients; males with partners of childbearing potential must use condoms; females must be non-childbearing (surgically sterilised or postmenopausal confirmed by hormone tests if needed)
- Documented diagnosis of IPF confirmed by investigator per 2022 ATS/ERS/JRS/ALAT Guidelines, with biopsy report if available
- High-resolution CT scan within 12 months or during screening showing "UIP" or "probable UIP" pattern consistent with IPF confirmed by central review
- Patients with "indeterminate" or "alternative diagnosis" HRCT findings eligible if historical biopsy shows "UIP" or "probable UIP" pattern
- Fibrosis extent of 20% or more on HRCT within 12 months or during screening confirmed by central review
- Forced vital capacity (FVC) at least 45% predicted at Visit 1
- Hemoglobin-corrected diffusing capacity of lungs for carbon monoxide (DLCO) at least 20% predicted at Visit 1
You will not qualify if you...
- Acute IPF exacerbation within 12 weeks prior to Visit 1 or during screening
- Significant airway obstruction (FEV1/FVC ratio less than 0.7) at Visit 1
- Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 or during screening
- Significant pulmonary hypertension defined by right heart failure, cardiac index ≤ 2 L/min/m², or requiring prostanoid parenteral therapy
- Treatment with nintedanib or pirfenidone for less than 12 weeks prior to Visit 1, planning to start these treatments within first 12 weeks of study treatment, or combined nintedanib plus pirfenidone treatment
- Severe uncontrolled hypertension (≥160/100 mmHg) within 3 months prior to Visit 1
- Myocardial infarction, stroke, or transient ischemic attack within 6 months prior to Visit 1
- Unstable cardiac angina within 6 months prior to Visit 1
- Life expectancy less than 2.5 years due to diseases other than IPF as assessed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 47 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Banner - University Medical Center Tucson
Tucson, Arizona, United States, 85724
Not Yet Recruiting
3
University of Florida
Gainesville, Florida, United States, 32610
Not Yet Recruiting
4
Renstar Medical Research
Ocala, Florida, United States, 34470
Actively Recruiting
5
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
6
University of Kansas Medical Center
Kansas City, Kansas, United States, 66103-2937
Not Yet Recruiting
7
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
8
The Lung Research Center, LLC
Chesterfield, Missouri, United States, 63017
Actively Recruiting
9
University of Missouri Health System
Columbia, Missouri, United States, 65212
Not Yet Recruiting
10
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
11
Weill Cornell Medical College
New York, New York, United States, 10065
Not Yet Recruiting
12
Duke University Medical Center
Durham, North Carolina, United States, 27710
Not Yet Recruiting
13
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
Not Yet Recruiting
14
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
15
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, United States, 37067
Actively Recruiting
16
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Not Yet Recruiting
17
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Actively Recruiting
18
Monash Health
Clayton, Victoria, Australia, 3168
Not Yet Recruiting
19
Institute for Respiratory Health
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
20
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Not Yet Recruiting
21
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, Belgium, 5530
Not Yet Recruiting
22
Synergy Respiratory Care
Sherwood Park, Alberta, Canada, T8H 0N2
Actively Recruiting
23
Kelowna Respirology & Allergy Research
Kelowna, British Columbia, Canada, V1Y 3H5
Actively Recruiting
24
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Not Yet Recruiting
25
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
26
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany, 45239
Actively Recruiting
27
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
28
ASST Papa Giovanni XXIII
Bergamo, Italy, 24127
Not Yet Recruiting
29
A. O. Universitaria Careggi
Florence, Italy, 50137
Not Yet Recruiting
30
A.O. dei Colli
Naples, Italy, 80131
Not Yet Recruiting
31
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
32
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Torino, Italy, 10126
Actively Recruiting
33
Tosei General Hospital
Aichi, Seto, Japan, 489-8642
Not Yet Recruiting
34
University of Fukui Hospital
Fukui, Yoshida-gun, Japan, 910-1193
Actively Recruiting
35
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, Japan, 810-8563
Not Yet Recruiting
36
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, Japan, 236-0051
Actively Recruiting
37
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, Japan, 591-8555
Actively Recruiting
38
Hamamatsu University Hospital
Shizuoka, Hamamatsu, Japan, 431-3192
Not Yet Recruiting
39
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea, 14584
Actively Recruiting
40
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
Actively Recruiting
41
Soonchunhyang University Hospital Seoul
Seoul, South Korea, 04401
Not Yet Recruiting
42
Hospital Vall Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
43
Hospital Universitari de Bellvitge
L Hospitalet Del Llobregat, Spain, 08907
Actively Recruiting
44
Hospital Universitario De La Princesa
Madrid, Spain, 08035
Actively Recruiting
45
Hospital Virgen del Rocío
Seville, Spain, 41013
Not Yet Recruiting
46
Cantonal Hospital of Aarau
Aarau, Switzerland, 5001
Actively Recruiting
47
Universitätsspital Basel
Basel, Switzerland, 4031
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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