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
NCT ID: NCT07036523
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
71 participants
INTERVENTIONAL
2025-11-15
2027-09-02
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BI 765423
BI 765423
BI 765423
Placebo
Placebo
Placebo to BI 765423
Interventions
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BI 765423
BI 765423
Placebo
Placebo to BI 765423
Eligibility Criteria
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Inclusion Criteria
2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
3. Male or female patients. Male patients with Woman of childbearing potential (WOCBP) sexual partners must use contraception (male condom) to avoid exposure via seminal fluid during treatment and for a specific period after last drug intake. Women can only be included if they are of non-childbearing potential, defined as meeting at least one of the below conditions:
* Permanently surgically sterilised (hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy)
* Postmenopausal, defined as no menses for 12 months without an alternative medical cause. In questionable cases of postmenopausal status:
* Women not using sex hormone medication such as hormone replacement therapy may be included if a blood sample confirms levels of follicle stimulating hormone (FSH) \> 40 U/L and estradiol \< 30 ng/L"
4. Patients with a documented diagnosis of IPF prior to Visit 1, confirmed by the investigator as per the 2022 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) Guideline and, if available, surgical lung biopsy or transbronchial lung cryobiopsy histopathology report.
5. Patients with a high-resolution computed tomography (HRCT) taken within 12 months of Visit 1 (or during the screening period, if not available) confirming "UIP" or "probable UIP" HRCT pattern consistent with the clinical diagnosis of IPF by central review (prior to Visit 2).
* Patients with an "indeterminate" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed based on an historical histopathology report of a surgical lung biopsy or cryobiopsy demonstrating a "UIP" or "Probable UIP" pattern.
* Patients with an "alternative diagnosis" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed based on an historical histopathology report of a surgical lung biopsy or cryobiopsy demonstrating a "UIP" pattern."
6. Patients with an extent of fibrosis ≥20% as per an HRCT of the chest performed within 12 months prior to Visit 1 or during the screening period (if not available) and confirmed by central review.
7. Patients with a Forced vital capacity (FVC) ≥45% predicted at Visit 1. Predicted normal values will be calculated according to Global Lung Initiative (GLI).
8. Patients with haemoglobin-corrected diffusing capacity of the lungs for carbon monoxide (DLCO) ≥20% predicted at Visit 1.
Exclusion Criteria
2. Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC \<0.7) at Visit 1.
3. Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
4. Significant PH defined by any of the following:
* Previous clinical or echocardiographic evidence of significant right heart failure according to investigator's judgement
* History of right heart catheterisation showing a cardiac index ≤2 L/min/m\^²
* PH requiring parenteral therapy with prostanoids
5. On nintedanib or pirfenidone treatment for less than 12 weeks prior Visit 1, planning to start nintedanib or pirfenidone within the first 12 weeks of investigational medicinal product (IMP) treatment or on combined nintedanib plus pirfenidone treatment. Newly diagnosed patients considered in need of SoC treatment by the treating physician, who would be withheld SoC treatment only for the sake of participation in the trial, should also be excluded.
6. Cardiovascular comorbidities including
* Severe hypertension (uncontrolled under treatment≥160/100 mmHg at multiple occasions) within 3 months of Visit 1
* Myocardial infarction, stroke, or transient ischemic attack within 6 months of Visit 1
* Unstable cardiac angina within 6 months of Visit 1
7. Life expectancy for any concomitant disease other than IPF \<2.5 years (investigator assessment).
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner - University Medical Center Tucson
Tucson, Arizona, United States
University of Florida
Gainesville, Florida, United States
Ocala Lung and Critical Care
Ocala, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
The Lung Research Center, LLC
Chesterfield, Missouri, United States
University of Missouri Health System
Columbia, Missouri, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
The Oregon Clinic
Portland, Oregon, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, United States
University of Virginia Health System
Charlottesville, Virginia, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Institute for Respiratory Health
Nedlands, Western Australia, Australia
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, , Belgium
Synergy Respiratory Care
Sherwood Park, Alberta, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Fachkrankenhaus Coswig GmbH
Coswig, , Germany
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
A.O. dei Colli
Napoli, , Italy
AO Città della Salute e Scienza
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
Asan Medical Center
Seoul, , South Korea
Hospital Vall Hebron
Barcelona, , Spain
Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, , Spain
Hospital La Princesa
Madrid, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Cantonal Hospital of Aarau
Aarau, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Boehringer Ingelheim
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Related Links
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Related Info
Other Identifiers
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2025-520658-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1317-7542
Identifier Type: REGISTRY
Identifier Source: secondary_id
1493-0002
Identifier Type: -
Identifier Source: org_study_id