A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT06335303
Last Updated: 2025-11-12
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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ACTIVE_NOT_RECRUITING
PHASE2
322 participants
INTERVENTIONAL
2024-09-05
2026-01-09
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BI 1819479 low dose treatment group
BI 1819479
BI 1819479
BI 1819479 medium dose treatment group
BI 1819479
BI 1819479
BI 1819479 high dose treatment group
BI 1819479
BI 1819479
Placebo group
Placebo matching BI 1819479
Placebo matching BI 1819479
Interventions
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BI 1819479
BI 1819479
Placebo matching BI 1819479
Placebo matching BI 1819479
Eligibility Criteria
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Inclusion Criteria
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
4. On stable treatment with nintedanib or pirfenidone for at least 12 weeks or not on treatment with either nintedanib or pirfenidone for at least 12 weeks
5. Forced Vital Capacity (FVC) ≥45% of predicted normal.
6. Diffusion capacity of the lung for carbon monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb).
7. Women of childbearing potential (WOCBP) must use highly effective methods of birth control with low user dependency and additional barrier contraception for male partners (use of condom) until end of follow-up period.
8. Male trial participants with WOCBP partners must use contraception (condom) to avoid exposure via seminal fluid. Female partners of male trial participants must use highly effective methods of contraception during treatment until end of follow-up period.
Exclusion Criteria
2. Treated with immunosuppressive medications (other than oral corticosteroids) or prednisone \>15 mg/day or equivalent for respiratory or pulmonary reasons.
3. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
4. The patient is currently enrolled in another investigational device or drug trial, or their Visit 1 occurs less than 30 days or 5 half-lives (whichever is longer) after completing a previous investigational device or drug trial or receiving other investigational treatments.
5. Patients with a significant disease or condition other than the IPF under study, which in the opinion of the investigator, may put the patient at risk because of participation, interfere with trial procedures, or cause concern regarding the patient's ability to participate in the trial or any medical condition which could lead to a life expectancy \<12 months.
6. Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \<0.7).
7. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
8. Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
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
Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado, United States
Clinical Research Specialists LLC
Kissimmee, Florida, United States
SEC Clinical Research
Pensacola, Florida, United States
The Iowa Clinic, PC
West Des Moines, Iowa, United States
Advanced Pulmonary Research
Warren, Michigan, United States
Memorial Hospital Gulfport
Gulfport, Mississippi, United States
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
New Bern, North Carolina, United States
Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina, United States
Clinical Research Associates of Central PA
DuBois, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, United States
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
C.a.b.a, , Argentina
Hospital Britanico de Buenos Aires
CABA, , Argentina
Centro de Investigación Clinica Belgrano
CABA, , Argentina
CEDIC - Centro de Investigacion Clinica
CABA, , Argentina
Consultorios Médicos del Buen Ayre
Capital Federal, , Argentina
Canberra Hospital
Garran, Australian Capital Territory, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Launceston Respiratory & Sleep Centre
Launceston, Tasmania, Australia
Lung Research Victoria
Footscray, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Institute for Respiratory Health
Nedlands, Western Australia, Australia
Macquarie University
Macquarie Park, , Australia
Medical University of Graz State Hospital - University Hospital Graz
Graz, , Austria
Krems University Hospital
Krems, , Austria
Kepler Univ. Klinikum Linz
Linz, , Austria
Hospital Elisabethinen Linz
Linz, , Austria
Standort Penzing der Klinik Ottakring
Vienna, , Austria
Clinic Floridsdorf
Vienna, , Austria
Klinikum Wels - Grieskirchen GmbH
Wels, , Austria
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
CHR de la Citadelle
Liège, , Belgium
Serviços Medicos Respirar Sul Fluminense
Barra Mansa, , Brazil
Faculdade de Medicina de Botucatu - UNESP
Botucatu, , Brazil
Hospital das Clínicas da UFG - EBSERH
Goiânia, , Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, , Brazil
Pesquisare
Santo André, , Brazil
COE Sao Jose dos Campos
São José dos Campos, , Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, , Brazil
University of Calgary
Calgary, Alberta, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Toronto General Hospital
Toronto, Ontario, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Beijing Chao-Yang Hospital
Beijing, , China
The Second Xiangya Hospital Of Central South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
People's Hospital of Sichuan Province
Chengdu, , China
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Hangzhou First People's Hospital
Hangzhou, , China
Zhejiang Hospital
Hangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, , China
Anhui Provincial Hospital
Hefei, , China
Nanjing Drum Tower Hospital
Nanjing, , China
China Shenyang Chest Hospital
Shenyang, , China
Tianjin Medical University General Hospital
Tianjin, , China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, , China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, , China
Thomayer University Hospital
Prague, , Czechia
University Hospital Bulovka
Prague, , Czechia
Rigshospitalet-København Ø-69883
København Ø, , Denmark
Odense University Hospital
Odense, , Denmark
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, , Finland
Oulun yliopistollinen keskussairaala
Oulu, , Finland
Tampereen yliopistollinen sairaala
Tampere, , Finland
TYKS
Turku, , Finland
HOP d'Angers
Angers, , France
HOP Avicenne
Bobigny, , France
HOP Louis Pradel
Bron, , France
HOP CHU Caen
Caen, , France
INS Coeur Poumon
Lille, , France
HOP Nord
Marseille, , France
HOP Pasteur
Nice, , France
HOP Pontchaillou
Rennes, , France
Pneumologische Praxis Dr. Löh
Bad Homburg, , Germany
Charite Universitätsmedizin Berlin KöR
Berlin, , Germany
Universitätsklinikum Bonn AöR
Bonn, , Germany
Caritas-Krankenhaus St. Maria gGmbH
Donaustauf, , Germany
Klinikum Fulda gAG
Fulda, , Germany
Universitätsmedizin Greifswald
Greifswald, , Germany
Klinikum Region Hannover GmbH
Hanover, , Germany
Lungenklinik Hemer
Hemer, , Germany
Lungenfachklinik Immenhausen
Immenhausen, , Germany
Klinikum Konstanz
Konstanz, , Germany
Universität Leipzig
Leipzig, , Germany
Klinikum der Universität München AÖR
München, , Germany
Hospital of Heraklion (PAGNI)
Crete, , Greece
Univ. Gen. Hosp. of Ioannina
Ioannina, , Greece
University of Debrecen Clinical Centre
Debrecen, , Hungary
A. O. Universitaria Careggi
Florence, , Italy
Ospedale Colonnello D Avanzo
Foggia, , Italy
Ospedale G.B. Morgagni
Forlì, , Italy
Azienda Ospedaliera San Martino
Genova, , Italy
Ospedale Classificato San Giuseppe
Milan, , Italy
Azienda Ospedaliera Universitaria di Padova
Padua, , Italy
Pol. Universitario Tor Vergata
Roma, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, , Italy
Tosei General Hospital
Aichi, Seto, , Japan
University of Fukui Hospital
Fukui, Yoshida-gun, , Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, , Japan
Kyushu University Hospital
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
Tokushima University Hospital
Tokushima, Tokushima, , Japan
Kyorin University Hospital
Tokyo, Mitaka, , Japan
Toho University Omori Medical Center
Tokyo, Ota-ku, , Japan
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, , Japan
Hospital Sultan Idris Shah Serdang
Kajang, , Malaysia
Institut Perubatan Respiratori
Kuala Lumpur, , Malaysia
Sarawak General Hospital
Kuching, Sarawak, , Malaysia
Waikato Hospital
Hamilton, , New Zealand
Greenlane Clinical Centre
One Tree Hill, Auckland, , New Zealand
Haukeland Universitetssykehus
Bergen, , Norway
Akershus Universitetssykehus HF
Lørenskog, , Norway
Clin.Hosp.Med.Univ.Marcinkowski in Poznan
Poznan, , Poland
Alergopneuma Medical Center
Świdnik, , Poland
Singapore General Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, , South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Soonchunhyang University Hospital Seoul
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Hospital de Galdakao
Galdakao, , Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, , Spain
Hospital La Princesa
Madrid, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Central de Asturias
Oviedo, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Clínico de Santiago
Santiago de Compostela, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Karolinska University Hospital
Stockholm, , Sweden
CTC Clinical Trial Consultants AB
Uppsala, , Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
Chulalongkorn Hospital
Bangkok, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
Ramathibodi Hospital
Ratchathewi, , Thailand
Songklanagarind Hospital
Thailand, , Thailand
Heartlands Hospital
Birmingham, , United Kingdom
Castle Hill Hospital
Cottingham, Hull, , United Kingdom
Royal Devon and Exeter Hospital, Wonford
Exeter, , United Kingdom
Royal Lancaster Infirmary
Lancaster, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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2023-508395-11-00
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1302-4283
Identifier Type: OTHER
Identifier Source: secondary_id
1462-0004
Identifier Type: -
Identifier Source: org_study_id