A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

A Randomised, Double-blind, Placebo-controlled, Dose-finding Study Evaluating Efficacy, Safety, and Tolerability of Different Oral Doses of BI 1819479 Over at Least 24 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: BI 1819479; Drug: Placebo matching BI 1819479

• Study Type: Interventional
• Enrollment (Actual): 322
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • C.a.b.a, Argentina, 1056
    • Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
  • CABA, Argentina, C1060ABN
    • CEDIC - Centro de Investigacion Clinica
  • CABA, Argentina, 1280AEB
    • Hospital Britanico de Buenos Aires
  • CABA, Argentina, 1425
    • Centro de Investigación Clinica Belgrano
  • Capital Federal, Argentina, 1425
    • Consultorios Médicos del Buen Ayre
• Australia
  • Macquarie Park, Australia, 2109
    • Macquarie University
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Canberra Hospital
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
  • Tasmania
    • Launceston, Tasmania, Australia, 7250
      • Launceston Respiratory & Sleep Centre
  • Victoria
    • Footscray, Victoria, Australia, 3011
      • Lung Research Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Hospital
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Institute for Respiratory Health
• Austria
  • Graz, Austria, 8036
    • Medical University of Graz State Hospital - University Hospital Graz
  • Krems, Austria, 3500
    • Krems University Hospital
  • Linz, Austria, 4020
    • Kepler Univ. Klinikum Linz
  • Linz, Austria
    • Hospital Elisabethinen Linz
  • Vienna, Austria, 1210
    • Clinic Floridsdorf
  • Vienna, Austria, 1140
    • Standort Penzing der Klinik Ottakring
  • Wels, Austria, 4600
    • Klinikum Wels - Grieskirchen GmbH
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-luc
  • Liège, Belgium, 4000
    • CHR de la Citadelle
• Brazil
  • Barra Mansa, Brazil, 27323240
    • Serviços Medicos Respirar Sul Fluminense
  • Botucatu, Brazil, 18618-687
    • Faculdade de Medicina de Botucatu - UNESP
  • Goiânia, Brazil, 74605-050
    • Hospital das Clínicas da UFG - EBSERH
  • Porto Alegre, Brazil, 90035-074
    • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Santo André, Brazil, 09080-110
    • Pesquisare
  • São José dos Campos, Brazil, 122241-660
    • COE Sao Jose dos Campos
  • São Paulo, Brazil, 01327-001
    • Hospital Alemao Oswaldo Cruz
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • QEII Health Sciences Centre
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre (MUHC)
• China
  • Beijing, China, 100020
    • Beijing Chao-Yang Hospital
  • Changsha, China, 410011
    • The second Xiangya hospital of central south university
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Chengdu, China, 610072
    • People's Hospital of Sichuan Province
  • Guangzhou, China, 510120
    • First Affiliated Hospital of Guangzhou Medical University
  • Hangzhou, China, 310013
    • Zhejiang Hospital
  • Hangzhou, China, 310006
    • Hangzhou First People's Hospital
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  • Hefei, China, 230001
    • Anhui Provincial Hospital
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Shenyang, China, 110000
    • China Shenyang Chest Hospital
  • Tianjin, China, 30052
    • Tianjin Medical University General Hospital
  • Wuhan, China, 430022
    • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
  • Xuzhou, China, 221009
    • Affiliated Hospital, Xuzhou Medical college
• Czechia
  • Prague, Czechia, 18081
    • University Hospital Bulovka
  • Prague, Czechia, 140 59
    • University Thomayer´s Hospital
• Denmark
  • København Ø, Denmark, 2100
    • Rigshospitalet-København Ø-69883
  • Odense, Denmark, 5000
    • Odense University Hospital
• Finland
  • Helsinki, Finland, 00029
    • HYKS Keuhkosairauksien tutkimusyksikkö
  • Oulu, Finland, 90220
    • Oulun yliopistollinen keskussairaala
  • Tampere, Finland, 33520
    • Tampereen Yliopistollinen Sairaala
  • Turku, Finland, 20520
    • TYKS
• France
  • Angers, France, 49933
    • HOP d'Angers
  • Bobigny, France, 93000
    • HOP Avicenne
  • Bron, France, 69677
    • HOP Louis Pradel
  • Caen, France, 14033
    • HOP CHU Caen
  • Lille, France, 59037
    • INS Coeur Poumon
  • Marseille, France, 13915
    • HOP Nord
  • Nice, France, 06001
    • HOP Pasteur
  • Rennes, France, 35033
    • HOP Pontchaillou
• Germany
  • Bad Homburg, Germany, 61350
    • Pneumologische Praxis Dr. Löh
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn AöR
  • Donaustauf, Germany, 99093
    • Caritas-Krankenhaus St. Maria gGmbH
  • Fulda, Germany, 36043
    • Klinikum Fulda gAG
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald
  • Hanover, Germany, 30459
    • Klinikum Region Hannover GmbH
  • Hemer, Germany, 58675
    • Lungenklinik Hemer
  • Immenhausen, Germany, 34376
    • Lungenfachklinik Immenhausen
  • Konstanz, Germany, 78464
    • Klinikum Konstanz
  • Leipzig, Germany, 04103
    • Universität Leipzig
  • München, Germany, 81377
    • Klinikum der Universität München AÖR
• Greece
  • Crete, Greece, 71500
    • Hospital of Heraklion (PAGNI)
  • Ioannina, Greece, 45 500
    • Univ. Gen. Hosp. of Ioannina
• Hungary
  • Debrecen, Hungary, 4032
    • University of Debrecen Clinical Centre
• Italy
  • Florence, Italy, 50137
    • A. O. Universitaria Careggi
  • Foggia, Italy, 71100
    • Ospedale Colonnello D Avanzo
  • Forlì, Italy, 47121
    • Ospedale G.B. Morgagni
  • Genova, Italy, 16132
    • Azienda Ospedaliera San Martino
  • Milan, Italy, 20123
    • Ospedale Classificato San Giuseppe
  • Padua, Italy, 35128
    • Azienda Ospedaliera Universitaria Di Padova
  • Roma, Italy, 00189
    • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
  • Roma, Italy, 00133
    • Pol. Universitario Tor Vergata
• Japan
  • Aichi, Seto, Japan, 489-8642
    • Tosei General Hospital
  • Fukui, Yoshida-gun, Japan, 910-1193
    • University of Fukui Hospital
  • Fukuoka, Fukuoka, Japan, 810-8563
    • National Hospital Organization Kyushu Medical Center
  • Fukuoka, Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Kanagawa, Yokohama, Japan, 236-0051
    • Kanagawa Cardiovascular and Respiratory Center
  • Osaka, Sakai, Japan, 591-8555
    • National Hospital Organization Kinki-chuo Chest Medical Center
  • Shizuoka, Hamamatsu, Japan, 431-3192
    • Hamamatsu University Hospital
  • Tokushima, Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Tokyo, Mitaka, Japan, 181-8611
    • Kyorin University Hospital
  • Tokyo, Ota-ku, Japan, 143-8541
    • Toho University Omori Medical Center
  • Tokyo, Shinjuku-ku, Japan, 162-8655
    • National Center for Global Health and Medicine
• Malaysia
  • Kajang, Malaysia, 43000
    • Hospital Sultan Idris Shah Serdang
  • Kuala Lumpur, Malaysia, 53000
    • Institut Perubatan Respiratori
  • Kuching, Sarawak, Malaysia, 93586
    • Sarawak General Hospital
• New Zealand
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • One Tree Hill, Auckland, New Zealand, 1051
    • Greenlane Clinical Centre
  • Auckland
    • Papatoetoe, Auckland, New Zealand, 2025
      • Aotearoa Clinical Trials
• Norway
  • Bergen, Norway, N-5021
    • Haukeland Universitetssykehus
  • Lørenskog, Norway, 1478
    • Akershus Universitetssykehus HF
• Poland
  • Poznan, Poland, 60-569
    • Clin.Hosp.Med.Univ.Marcinkowski in Poznan
  • Świdnik, Poland, 21040
    • Alergopneuma Medical Center
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
• South Korea
  • Bucheon-si, South Korea, 14647
    • The Catholic University of Korea, Bucheon St.Mary's Hospital
  • Busan, South Korea, 48108
    • Inje University Haeundae Paik Hospital
  • Seongnam, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 04401
    • Soonchunhyang University Hospital Seoul
  • Seoul, South Korea, 03722
    • Severance Hospital
  • Seoul, South Korea, 02447
    • Kyung Hee University Hospital
  • Seoul, South Korea, 01757
    • Inje University Sanggye Paik Hospital
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall D Hebron
  • Galdakao, Spain, 48960
    • Hospital de Galdakao
  • L'Hospitalet de Llobregat, Spain, 08907
    • Hospital Universitari de Bellvitge
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Oviedo, Spain, 33011
    • Hospital Central de Asturias
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla
  • Santiago de Compostela, Spain, 15706
    • Hospital Clínico de Santiago
  • Seville, Spain, 41013
    • Hospital Virgen del Rocío
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska University Hospital
  • Uppsala, Sweden, 752 37
    • CTC Clinical Trial Consultants AB
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taoyuan District, Taiwan, 333
    • Chang Gung Memorial Hospital, Linkou
• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
  • Ratchathewi, Thailand, 10400
    • Ramathibodi Hospital
  • Thailand, Thailand, 90110
    • Songklanagarind Hospital
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Heartlands Hospital
  • Cottingham, Hull, United Kingdom, HU16 5JQ
    • Castle Hill Hospital
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital, Wonford
  • Lancaster, United Kingdom, LA1 4RP
    • Royal Lancaster Infirmary
  • Leeds, United Kingdom, LS9 7TF
    • St James's University Hospital
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • Manchester, United Kingdom, M23 9LT
    • Wythenshawe Hospital
  • Oxford, United Kingdom, OX3 7LJ
    • Churchill Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Critical Care, Pulmonary and Sleep Associates
  • Florida
    • Kissimmee, Florida, United States, 34746
      • Clinical Research Specialists LLC - Kissimmee
    • Pensacola, Florida, United States, 32503
      • SEC Clinical Research
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic, PC
  • Michigan
    • Warren, Michigan, United States, 48088
      • Advanced Pulmonary Research
  • Mississippi
    • Gulfport, Mississippi, United States, 39501
      • Memorial Hospital Gulfport
  • North Carolina
    • New Bern, North Carolina, United States, 28562
      • Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center-Winston Salem-69289
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Clinical Research Associates of Central PA
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Lowcountry Lung and Critical Care
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Clinical Trials Center of Middle Tennessee, LLC
  • Virginia
    • Richmond, Virginia, United States, 23230
      • Pulmonary Associates of Richmond, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients ≥40 years old at the time of signed informed consent.
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:

1. Acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) within at least 12 weeks prior to screening and/or during the screening period (investigator-determined).
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.

Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Placebo matching BI 1819479; Placebo matching BI 1819479
Experimental: BI 1819479 low dose treatment group	Drug: BI 1819479; BI 1819479
Experimental: BI 1819479 medium dose treatment group	Drug: BI 1819479; BI 1819479
Experimental: BI 1819479 high dose treatment group	Drug: BI 1819479; BI 1819479

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Annual rate of decline in Forced Vital Capacity (FVC) [milliLiter/year]	Up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Absolute change from baseline in FVC at Week 24 [in milliLiter]	At baseline and at week 24

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2024
• Primary Completion (Actual): November 25, 2025
• Study Completion (Actual): January 16, 2026

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 1462-0004; 2023-508395-11-00 (Other Identifier: CTIS); U1111-1302-4283 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: 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.

IPD Sharing Access Criteria

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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No