Actively Recruiting
A Double-blind, Randomised, Placebo-controlled Trial to Evaluate BI 765423 Infusion With or Without Standard Treatment in Adults With Idiopathic Pulmonary Fibrosis
Led by Boehringer Ingelheim · Updated on 2026-05-27
71
Participants Needed
47
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a medicine called BI 765423 in adults aged 40 years and older who have idiopathic pulmonary fibrosis (IPF). The study aims to find out if BI 765423 can improve lung function compared to a placebo over a 3-month period. Participants must have confirmed lung fibrosis of 20% or more and a forced vital capacity (FVC) of at least 45% predicted, with diagnosis verified by high-resolution CT scans. Participants are randomly assigned to one of two groups: one receives BI 765423 and the other receives a placebo that looks like the medicine but contains no active drug. The study medicine is given as an intravenous infusion every four weeks. Participants may continue their regular IPF treatment during the study. The total study duration is 8 to 10 months, including screening, treatment, and follow-up periods. During the study, participants visit the study site several times for lung function tests, including measuring FVC, and blood samples are taken to assess markers related to lung health. The main outcome measured is the change in lung capacity after 12 weeks. Other assessments include walking distance during a 6-minute walk test and oxygen levels at rest. Health and any side effects are regularly monitored throughout the study.
CONDITIONS
Brief 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.
- Signed informed consent according to ICH-GCP and local laws.
- Male or female; women must be of non-childbearing potential or surgically sterilised.
- Documented diagnosis of idiopathic pulmonary fibrosis (IPF) confirmed by guidelines and biopsy if available.
- High-resolution CT scan within 12 months showing UIP or probable UIP pattern, confirmed by central review.
- Lung fibrosis extent of 20% or more confirmed by CT scan.
- Forced vital capacity (FVC) of at least 45% predicted at Visit 1.
- Diffusing capacity of the lungs for carbon monoxide (DLCO) of at least 20% predicted at Visit 1.
You will not qualify if you...
- Acute exacerbation of IPF within 12 weeks before Visit 1 or during screening.
- Significant airway obstruction with FEV1/FVC ratio less than 0.7 at Visit 1.
- Recent lower respiratory tract infection needing treatment within 4 weeks before Visit 1 or during screening.
- Significant pulmonary hypertension or right heart failure.
- Treatment with nintedanib or pirfenidone for less than 12 weeks before Visit 1, or planned changes to these treatments during first 12 weeks of study drug.
- Severe cardiovascular conditions including uncontrolled hypertension, recent heart attack, stroke, or unstable angina.
- Life expectancy under 2.5 years due to other diseases besides IPF.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive BI 765423 or placebo infusions to evaluate effects on lung function.
Baseline visit and follow-up visits at 12 weeks
Trial Site Locations
Total: 47 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively 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
Actively 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
Actively 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
Actively 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
Actively Recruiting
42
Hospital Vall Hebron
Barcelona, Spain, 08035
Actively 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
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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