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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508395-11-00 | Other Identifier | CTIS | |
| U1111-1302-4283 | Other Identifier | WHO |
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This study is open to adults 40 years or older with idiopathic pulmonary fibrosis (IPF). People can join the study if they are not on any treatment for IPF are on stable treatment for at least 3 months before starting the study. The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study.
Participants are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1819479. Participants in 1 group get placebo. Placebo tablets look like BI 1819479 tablets, but do not contain any medicine. Participants take the treatment for 6 months to 1 year. Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site between 10 and 12 times and get up to 11 phone calls from the site staff.
At site visits doctors regularly perform breathing tests that measure how well the lungs are working. Researchers compare the results between participants who take BI 1819479 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1819479 low dose treatment group | Experimental |
| |
| BI 1819479 medium dose treatment group | Experimental |
| |
| BI 1819479 high dose treatment group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1819479 | Drug | BI 1819479 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annual rate of decline in Forced Vital Capacity (FVC) [milliLiter/year] | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in FVC at Week 24 [in milliLiter] | At baseline and at week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Critical Care, Pulmonary and Sleep Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41846682 | Derived | Wuyts WA, Bonella F, Ishii H, Lee JS, Renzoni E, Hadl S, Krzykalla J, Stowasser S, Engel M, Molina MM. Design of a phase II randomised, double-blind, placebo-controlled, dose-finding trial of BI 1819479 in patients with idiopathic pulmonary fibrosis. ERJ Open Res. 2026 Mar 16;12(2):00973-2025. doi: 10.1183/23120541.00973-2025. eCollection 2026 Mar. |
| 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.clinicalstudies.boehringer-ingelheim.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's publication plan); 2. and upon signing of a legal agreement.
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| Placebo matching BI 1819479 | Drug | Placebo matching BI 1819479 |
|
| Lakewood |
| Colorado |
| 80228 |
| United States |
| Clinical Research Specialists LLC - Kissimmee | Kissimmee | Florida | 34746 | United States |
| SEC Clinical Research | Pensacola | Florida | 32503 | United States |
| The Iowa Clinic, PC | West Des Moines | Iowa | 50266 | United States |
| Advanced Pulmonary Research | Warren | Michigan | 48088 | United States |
| Memorial Hospital Gulfport | Gulfport | Mississippi | 39501 | United States |
| Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine | New Bern | North Carolina | 28562 | United States |
| Southeastern Research Center-Winston Salem-69289 | Winston-Salem | North Carolina | 27103 | United States |
| Clinical Research Associates of Central PA | DuBois | Pennsylvania | 15801 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Lowcountry Lung and Critical Care | Charleston | South Carolina | 29406 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| Clinical Trials Center of Middle Tennessee, LLC | Franklin | Tennessee | 37067 | United States |
| Pulmonary Associates of Richmond, Inc. | Richmond | Virginia | 23230 | United States |
| Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553 | C.a.b.a | 1056 | Argentina |
| Hospital Britanico de Buenos Aires | CABA | 1280AEB | Argentina |
| Centro de Investigación Clinica Belgrano | CABA | 1425 | Argentina |
| CEDIC - Centro de Investigacion Clinica | CABA | C1060ABN | Argentina |
| Consultorios Médicos del Buen Ayre | Capital Federal | 1425 | Argentina |
| Canberra Hospital | Garran | Australian Capital Territory | 2605 | Australia |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Launceston Respiratory & Sleep Centre | Launceston | Tasmania | 7250 | Australia |
| Lung Research Victoria | Footscray | Victoria | 3011 | Australia |
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Institute for Respiratory Health | Nedlands | Western Australia | 6009 | Australia |
| Macquarie University | Macquarie Park | 2109 | Australia |
| Medical University of Graz State Hospital - University Hospital Graz | Graz | 8036 | Austria |
| Krems University Hospital | Krems | 3500 | Austria |
| Kepler Univ. Klinikum Linz | Linz | 4020 | Austria |
| Hospital Elisabethinen Linz | Linz | Austria |
| Standort Penzing der Klinik Ottakring | Vienna | 1140 | Austria |
| Clinic Floridsdorf | Vienna | 1210 | Austria |
| Klinikum Wels - Grieskirchen GmbH | Wels | 4600 | Austria |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| CHR de la Citadelle | Liège | 4000 | Belgium |
| Serviços Medicos Respirar Sul Fluminense | Barra Mansa | 27323240 | Brazil |
| Faculdade de Medicina de Botucatu - UNESP | Botucatu | 18618-687 | Brazil |
| Hospital das Clínicas da UFG - EBSERH | Goiânia | 74605-050 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | 90035-074 | Brazil |
| Pesquisare | Santo André | 09080-110 | Brazil |
| COE Sao Jose dos Campos | São José dos Campos | 122241-660 | Brazil |
| Hospital Alemao Oswaldo Cruz | São Paulo | 01327-001 | Brazil |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| QEII Health Sciences Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| McGill University Health Centre (MUHC) | Montreal | Quebec | H4A 3J1 | Canada |
| Beijing Chao-Yang Hospital | Beijing | 100020 | China |
| The Second Xiangya Hospital Of Central South University | Changsha | 410011 | China |
| West China Hospital, Sichuan University | Chengdu | 610041 | China |
| People's Hospital of Sichuan Province | Chengdu | 610072 | China |
| First Affiliated Hospital of Guangzhou Medical University | Guangzhou | 510120 | China |
| Hangzhou First People's Hospital | Hangzhou | 310006 | China |
| Zhejiang Hospital | Hangzhou | 310013 | China |
| Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine | Hangzhou | 310016 | China |
| Anhui Provincial Hospital | Hefei | 230001 | China |
| Nanjing Drum Tower Hospital | Nanjing | 210008 | China |
| China Shenyang Chest Hospital | Shenyang | 110000 | China |
| Tianjin Medical University General Hospital | Tianjin | 30052 | China |
| Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T | Wuhan | 430022 | China |
| Affiliated Hospital, Xuzhou Medical college | Xuzhou | 221009 | China |
| University Thomayer´s Hospital | Prague | 140 59 | Czechia |
| University Hospital Bulovka | Prague | 18081 | Czechia |
| Rigshospitalet-København Ø-69883 | København Ø | 2100 | Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| HYKS Keuhkosairauksien tutkimusyksikkö | Helsinki | 00029 | Finland |
| Oulun yliopistollinen keskussairaala | Oulu | 90220 | Finland |
| Tampereen yliopistollinen sairaala | Tampere | 33520 | Finland |
| TYKS | Turku | 20520 | Finland |
| HOP d'Angers | Angers | 49933 | France |
| HOP Avicenne | Bobigny | 93000 | France |
| HOP Louis Pradel | Bron | 69677 | France |
| HOP CHU Caen | Caen | 14033 | France |
| INS Coeur Poumon | Lille | 59037 | France |
| HOP Nord | Marseille | 13915 | France |
| HOP Pasteur | Nice | 06001 | France |
| HOP Pontchaillou | Rennes | 35033 | France |
| Pneumologische Praxis Dr. Löh | Bad Homburg | 61350 | Germany |
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Universitätsklinikum Bonn AöR | Bonn | 53127 | Germany |
| Caritas-Krankenhaus St. Maria gGmbH | Donaustauf | 99093 | Germany |
| Klinikum Fulda gAG | Fulda | 36043 | Germany |
| Universitätsmedizin Greifswald | Greifswald | 17475 | Germany |
| Klinikum Region Hannover GmbH | Hanover | 30459 | Germany |
| Lungenklinik Hemer | Hemer | 58675 | Germany |
| Lungenfachklinik Immenhausen | Immenhausen | 34376 | Germany |
| Klinikum Konstanz | Konstanz | 78464 | Germany |
| Universität Leipzig | Leipzig | 04103 | Germany |
| Klinikum der Universität München AÖR | München | 81377 | Germany |
| Hospital of Heraklion (PAGNI) | Crete | 71500 | Greece |
| Univ. Gen. Hosp. of Ioannina | Ioannina | 45 500 | Greece |
| University of Debrecen Clinical Centre | Debrecen | 4032 | Hungary |
| A. O. Universitaria Careggi | Florence | 50137 | Italy |
| Ospedale Colonnello D Avanzo | Foggia | 71100 | Italy |
| Ospedale G.B. Morgagni | Forlì | 47121 | Italy |
| Azienda Ospedaliera San Martino | Genova | 16132 | Italy |
| Ospedale Classificato San Giuseppe | Milan | 20123 | Italy |
| Azienda Ospedaliera Universitaria di Padova | Padova | 35128 | Italy |
| Pol. Universitario Tor Vergata | Roma | 00133 | Italy |
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma | 00168 | Italy |
| Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza | Roma | 00189 | Italy |
| Tosei General Hospital | Aichi, Seto | 489-8642 | Japan |
| University of Fukui Hospital | Fukui, Yoshida-gun | 910-1193 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuoka, Fukuoka | 810-8563 | Japan |
| Kyushu University Hospital | Fukuoka, Fukuoka | 812-8582 | Japan |
| Kanagawa Cardiovascular and Respiratory Center | Kanagawa, Yokohama | 236-0051 | Japan |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Osaka, Sakai | 591-8555 | Japan |
| Hamamatsu University Hospital | Shizuoka, Hamamatsu | 431-3192 | Japan |
| Tokushima University Hospital | Tokushima, Tokushima | 770-8503 | Japan |
| Kyorin University Hospital | Tokyo, Mitaka | 181-8611 | Japan |
| Toho University Omori Medical Center | Tokyo, Ota-ku | 143-8541 | Japan |
| National Center for Global Health and Medicine | Tokyo, Shinjuku-ku | 162-8655 | Japan |
| Hospital Sultan Idris Shah Serdang | Kajang | 43000 | Malaysia |
| Institut Perubatan Respiratori | Kuala Lumpur | 53000 | Malaysia |
| Sarawak General Hospital | Kuching, Sarawak | 93586 | Malaysia |
| Aotearoa Clinical Trials | Papatoetoe | Auckland | 2025 | New Zealand |
| Waikato Hospital | Hamilton | 3240 | New Zealand |
| Greenlane Clinical Centre | One Tree Hill, Auckland | 1051 | New Zealand |
| Haukeland Universitetssykehus | Bergen | N-5021 | Norway |
| Akershus Universitetssykehus HF | Lørenskog | 1478 | Norway |
| Clin.Hosp.Med.Univ.Marcinkowski in Poznan | Poznan | 60-569 | Poland |
| Alergopneuma Medical Center | Świdnik | 21040 | Poland |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| The Catholic University of Korea, Bucheon St.Mary's Hospital | Bucheon-si | 14647 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| Inje University Sanggye Paik Hospital | Seoul | 01757 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Soonchunhyang University Hospital Seoul | Seoul | 04401 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Universitari Vall D Hebron | Barcelona | 08035 | Spain |
| Hospital de Galdakao | Galdakao | 48960 | Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital Universitario De La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Clínico de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Karolinska University Hospital | Stockholm | 171 76 | Sweden |
| CTC Clinical Trial Consultants AB | Uppsala | 752 37 | Sweden |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Chang Gung Memorial Hospital, Linkou | Taoyuan | 333 | Taiwan |
| Chulalongkorn Hospital | Bangkok | 10330 | Thailand |
| Srinagarind Hospital | Khon Kaen | 40002 | Thailand |
| Ramathibodi Hospital | Ratchathewi | 10400 | Thailand |
| Songklanagarind Hospital | Thailand | 90110 | Thailand |
| Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| Castle Hill Hospital | Cottingham, Hull | HU16 5JQ | United Kingdom |
| Royal Devon and Exeter Hospital, Wonford | Exeter | EX2 5DW | United Kingdom |
| Royal Lancaster Infirmary | Lancaster | LA1 4RP | United Kingdom |
| St James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| Wythenshawe Hospital | Manchester | M23 9LT | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| 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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