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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520658-12-00 | Registry Identifier | CTIS (EU) | |
| U1111-1317-7542 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 765423 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 765423 | Drug | BI 765423 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in FVC (mL) at 12 weeks | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in log 10- transformed SP-D plasma concentration at 12 weeks | SP-D=Surfactant protein D | Baseline, 12 weeks |
| Absolute change from baseline in distance walked (m) during 6MWT at 12 weeks |
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Inclusion Criteria :
40 years of age or older at the time of informed consent signature.
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.
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:
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.
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 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.
Patients with a Forced vital capacity (FVC) ≥45% predicted at Visit 1. Predicted normal values will be calculated according to Global Lung Initiative (GLI).
Patients with haemoglobin-corrected diffusing capacity of the lungs for carbon monoxide (DLCO) ≥20% predicted at Visit 1.
Further inclusion criteria apply.
Exclusion criteria:
Acute exacerbation of IPF within at least 12 weeks prior to Visit 1 and/or during the screening period (investigator-determined).
Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC <0.7) at Visit 1.
Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
Significant PH defined by any of the following:
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.
Cardiovascular comorbidities including
Life expectancy for any concomitant disease other than IPF <2.5 years (investigator assessment).
Further exclusion criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor'spublication plan); 2. and upon signing of a legal agreement.
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| Drug |
Placebo to BI 765423 |
|
6MWT=6-minute walk test
| Baseline, 12 weeks |
| Absolute change from baseline in FVC % predicted at 12 weeks | Baseline, 12 weeks |
| Absolute change from baseline in DLCO % predicted at 12 weeks | DLCO=Diffusing Capacity of the Lungs for Carbon Monoxide | Baseline, 12 weeks |
| Absolute change from baseline in SpO2 on room air at rest at 12 weeks | SPO2=Oxygen saturation | Baseline, 12 weeks |
| University of Florida | Not yet recruiting | Gainesville | Florida | 32610 | United States |
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| Renstar Medical Research | Recruiting | Ocala | Florida | 34470 | United States |
|
| University of Iowa Hospitals and Clinics | Not yet recruiting | Iowa City | Iowa | 52242 | United States |
|
| University of Kansas Medical Center | Not yet recruiting | Kansas City | Kansas | 66103-2937 | United States |
|
| University of Minnesota | Not yet recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| The Lung Research Center, LLC | Recruiting | Chesterfield | Missouri | 63017 | United States |
|
| University of Missouri Health System | Not yet recruiting | Columbia | Missouri | 65212 | United States |
|
| Columbia University Medical Center-New York Presbyterian Hospital | Recruiting | New York | New York | 10032 | United States |
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| Weill Cornell Medical College | Recruiting | New York | New York | 10065 | United States |
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| Duke University Medical Center | Not yet recruiting | Durham | North Carolina | 27710 | United States |
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| University of Cincinnati Medical Center | Not yet recruiting | Cincinnati | Ohio | 45267 | United States |
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| Temple University Hospital | Recruiting | Philadelphia | Pennsylvania | 19140 | United States |
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| Clinical Trials Center of Middle Tennessee, LLC | Recruiting | Franklin | Tennessee | 37067 | United States |
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| University of Virginia Health System | Not yet recruiting | Charlottesville | Virginia | 22903 | United States |
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| The Prince Charles Hospital | Recruiting | Chermside | Queensland | 4032 | Australia |
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| Monash Health | Recruiting | Clayton | Victoria | 3168 | Australia |
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| Institute for Respiratory Health | Recruiting | Nedlands | Western Australia | 6009 | Australia |
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| Cliniques Universitaires Saint-Luc | Not yet recruiting | Brussels | 1200 | Belgium |
|
| Yvoir - UNIV UCL de Mont-Godinne | Not yet recruiting | Yvoir | 5530 | Belgium |
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| Synergy Respiratory Care | Recruiting | Sherwood Park | Alberta | T8H 0N2 | Canada |
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| Kelowna Respirology & Allergy Research | Recruiting | Kelowna | British Columbia | V1Y 3H5 | Canada |
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| QEII Health Sciences Centre | Recruiting | Halifax | Nova Scotia | B3H 3A7 | Canada |
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| Centre Hospitalier de l'Universite de Montreal (CHUM) | Recruiting | Montreal | Quebec | H2X 0A9 | Canada |
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| Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH | Recruiting | Essen | 45239 | Germany |
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| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
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| ASST Papa Giovanni XXIII | Not yet recruiting | Bergamo | 24127 | Italy |
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| A. O. Universitaria Careggi | Not yet recruiting | Florence | 50137 | Italy |
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| Azienda Ospedaliera dei Colli | Not yet recruiting | Naples | 80131 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
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| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino | Recruiting | Torino | 10126 | Italy |
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| Tosei General Hospital | Not yet recruiting | Aichi, Seto | 489-8642 | Japan |
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| University of Fukui Hospital | Recruiting | Fukui, Yoshida-gun | 910-1193 | Japan |
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| National Hospital Organization Kyushu Medical Center | Recruiting | Fukuoka, Fukuoka | 810-8563 | Japan |
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| Kanagawa Cardiovascular and Respiratory Center | Recruiting | Kanagawa, Yokohama | 236-0051 | Japan |
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| National Hospital Organization Kinki-Chuo Chest Medical Center | Recruiting | Osaka, Sakai | 591-8555 | Japan |
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| Hamamatsu University Hospital | Recruiting | Shizuoka, Hamamatsu | 431-3192 | Japan |
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| Soon Chun Hyang University Hospital Bucheon | Recruiting | Bucheon-si, Gyeonggi-do | 14584 | South Korea |
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| Inje University Haeundae Paik Hospital | Recruiting | Busan | 48108 | South Korea |
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| Soonchunhyang University Hospital Seoul | Recruiting | Seoul | 04401 | South Korea |
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| Hospital Vall Hebron | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Universitari de Bellvitge | Recruiting | L Hospitalet Del Llobregat | 08907 | Spain |
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| Hospital Universitario De La Princesa | Recruiting | Madrid | 08035 | Spain |
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| Hospital Virgen del Rocío | Not yet recruiting | Seville | 41013 | Spain |
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| Cantonal Hospital of Aarau | Recruiting | Aarau | 5001 | Switzerland |
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| Universitätsspital Basel | Recruiting | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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