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

NCT06335303 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: 1462-00042023-508395-11-00U1111-1302-4283
• Study Type: interventional
• Target: 322
• Locations: 27 countries
• Sites: 155

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Annual rate of decline in Forced Vital Capacity (FVC) [milliLiter/year]

  Up to 52 weeks

Secondary Outcomes (1)

• Absolute change from baseline in FVC at Week 24 [in milliLiter]

  At baseline and at week 24

Study Arms (4)

BI 1819479 low dose treatment group

EXPERIMENTAL

Drug: BI 1819479

BI 1819479 medium dose treatment group

EXPERIMENTAL

Drug: BI 1819479

BI 1819479 high dose treatment group

EXPERIMENTAL

Drug: BI 1819479

Placebo group

PLACEBO COMPARATOR

Drug: Placebo matching BI 1819479

Interventions

BI 1819479 DRUG

BI 1819479

BI 1819479 high dose treatment group; BI 1819479 low dose treatment group; BI 1819479 medium dose treatment group

Placebo matching BI 1819479 DRUG

Placebo matching BI 1819479

Placebo group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥40 years old at the time of signed informed consent.
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
• Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
• 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
• Forced Vital Capacity (FVC) ≥45% of predicted normal.
• Diffusion capacity of the lung for carbon monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb).
• 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.
• 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.

You may not qualify if:

• Acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) within at least 12 weeks prior to screening and/or during the screening period (investigator-determined).
• Treated with immunosuppressive medications (other than oral corticosteroids) or prednisone \>15 mg/day or equivalent for respiratory or pulmonary reasons.
• 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.
• 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.
• 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.
• Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \<0.7).
• In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
• Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (163)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Critical Care, Pulmonary and Sleep Associates

Lakewood, Colorado, 80228, United States

Location

Clinical Research Specialists LLC - Kissimmee

Kissimmee, Florida, 34746, United States

Location

SEC Clinical Research

Pensacola, Florida, 32503, United States

Location

The Iowa Clinic, PC

West Des Moines, Iowa, 50266, United States

Location

Advanced Pulmonary Research

Warren, Michigan, 48088, United States

Location

Memorial Hospital Gulfport

Gulfport, Mississippi, 39501, United States

Location

Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine

New Bern, North Carolina, 28562, United States

Location

Southeastern Research Center-Winston Salem-69289

Winston-Salem, North Carolina, 27103, United States

Location

Clinical Research Associates of Central PA

DuBois, Pennsylvania, 15801, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Lowcountry Lung and Critical Care

Charleston, South Carolina, 29406, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Clinical Trials Center of Middle Tennessee, LLC

Franklin, Tennessee, 37067, United States

Location

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, 23230, United States

Location

Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553

C.a.b.a, 1056, Argentina

Location

Hospital Britanico de Buenos Aires

CABA, 1280AEB, Argentina

Location

Centro de Investigación Clinica Belgrano

CABA, 1425, Argentina

Location

CEDIC - Centro de Investigacion Clinica

CABA, C1060ABN, Argentina

Location

Consultorios Médicos del Buen Ayre

Capital Federal, 1425, Argentina

Location

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Launceston Respiratory & Sleep Centre

Launceston, Tasmania, 7250, Australia

Location

Lung Research Victoria

Footscray, Victoria, 3011, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Institute for Respiratory Health

Nedlands, Western Australia, 6009, Australia

Location

Macquarie University

Macquarie Park, 2109, Australia

Location

Medical University of Graz State Hospital - University Hospital Graz

Graz, 8036, Austria

Location

Krems University Hospital

Krems, 3500, Austria

Location

Kepler Univ. Klinikum Linz

Linz, 4020, Austria

Location

Hospital Elisabethinen Linz

Linz, Austria

Location

Standort Penzing der Klinik Ottakring

Vienna, 1140, Austria

Location

Clinic Floridsdorf

Vienna, 1210, Austria

Location

Klinikum Wels - Grieskirchen GmbH

Wels, 4600, Austria

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

CHR de la Citadelle

Liège, 4000, Belgium

Location

Serviços Medicos Respirar Sul Fluminense

Barra Mansa, 27323240, Brazil

Location

Faculdade de Medicina de Botucatu - UNESP

Botucatu, 18618-687, Brazil

Location

Hospital das Clínicas da UFG - EBSERH

Goiânia, 74605-050, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, 90035-074, Brazil

Location

Pesquisare

Santo André, 09080-110, Brazil

Location

COE Sao Jose dos Campos

São José dos Campos, 122241-660, Brazil

Location

Hospital Alemao Oswaldo Cruz

São Paulo, 01327-001, Brazil

Location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

McGill University Health Centre (MUHC)

Montreal, Quebec, H4A 3J1, Canada

Location

Beijing Chao-Yang Hospital

Beijing, 100020, China

Location

The Second Xiangya Hospital Of Central South University

Changsha, 410011, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

People's Hospital of Sichuan Province

Chengdu, 610072, China

Location

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120, China

Location

Hangzhou First People's Hospital

Hangzhou, 310006, China

Location

Zhejiang Hospital

Hangzhou, 310013, China

Location

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, 310016, China

Location

Anhui Provincial Hospital

Hefei, 230001, China

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

China Shenyang Chest Hospital

Shenyang, 110000, China

Location

Tianjin Medical University General Hospital

Tianjin, 30052, China

Location

Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

Wuhan, 430022, China

Location

Affiliated Hospital, Xuzhou Medical college

Xuzhou, 221009, China

Location

University Thomayer´s Hospital

Prague, 140 59, Czechia

Location

University Hospital Bulovka

Prague, 18081, Czechia

Location

Rigshospitalet-København Ø-69883

København Ø, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

HYKS Keuhkosairauksien tutkimusyksikkö

Helsinki, 00029, Finland

Location

Oulun yliopistollinen keskussairaala

Oulu, 90220, Finland

Location

Tampereen yliopistollinen sairaala

Tampere, 33520, Finland

Location

TYKS

Turku, 20520, Finland

Location

HOP d'Angers

Angers, 49933, France

Location

HOP Avicenne

Bobigny, 93000, France

Location

HOP Louis Pradel

Bron, 69677, France

Location

HOP CHU Caen

Caen, 14033, France

Location

INS Coeur Poumon

Lille, 59037, France

Location

HOP Nord

Marseille, 13915, France

Location

HOP Pasteur

Nice, 06001, France

Location

HOP Pontchaillou

Rennes, 35033, France

Location

Pneumologische Praxis Dr. Löh

Bad Homburg, 61350, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Universitätsklinikum Bonn AöR

Bonn, 53127, Germany

Location

Caritas-Krankenhaus St. Maria gGmbH

Donaustauf, 99093, Germany

Location

Klinikum Fulda gAG

Fulda, 36043, Germany

Location

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

Location

Klinikum Region Hannover GmbH

Hanover, 30459, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

Location

Klinikum Konstanz

Konstanz, 78464, Germany

Location

Universität Leipzig

Leipzig, 04103, Germany

Location

Klinikum der Universität München AÖR

München, 81377, Germany

Location

Hospital of Heraklion (PAGNI)

Crete, 71500, Greece

Location

Univ. Gen. Hosp. of Ioannina

Ioannina, 45 500, Greece

Location

University of Debrecen Clinical Centre

Debrecen, 4032, Hungary

Location

A. O. Universitaria Careggi

Florence, 50137, Italy

Location

Ospedale Colonnello D Avanzo

Foggia, 71100, Italy

Location

Ospedale G.B. Morgagni

Forlì, 47121, Italy

Location

Azienda Ospedaliera San Martino

Genova, 16132, Italy

Location

Ospedale Classificato San Giuseppe

Milan, 20123, Italy

Location

Azienda Ospedaliera Universitaria di Padova

Padua, 35128, Italy

Location

Pol. Universitario Tor Vergata

Roma, 00133, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

Roma, 00189, Italy

Location

Tosei General Hospital

Aichi, Seto, 489-8642, Japan

Location

University of Fukui Hospital

Fukui, Yoshida-gun, 910-1193, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, 810-8563, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Kanagawa Cardiovascular and Respiratory Center

Kanagawa, Yokohama, 236-0051, Japan

Location

National Hospital Organization Kinki-Chuo Chest Medical Center

Osaka, Sakai, 591-8555, Japan

Location

Hamamatsu University Hospital

Shizuoka, Hamamatsu, 431-3192, Japan

Location

Tokushima University Hospital

Tokushima, Tokushima, 770-8503, Japan

Location

Kyorin University Hospital

Tokyo, Mitaka, 181-8611, Japan

Location

Toho University Omori Medical Center

Tokyo, Ota-ku, 143-8541, Japan

Location

National Center for Global Health and Medicine

Tokyo, Shinjuku-ku, 162-8655, Japan

Location

Hospital Sultan Idris Shah Serdang

Kajang, 43000, Malaysia

Location

Institut Perubatan Respiratori

Kuala Lumpur, 53000, Malaysia

Location

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

Aotearoa Clinical Trials

Papatoetoe, Auckland, 2025, New Zealand

Location

Waikato Hospital

Hamilton, 3240, New Zealand

Location

Greenlane Clinical Centre

One Tree Hill, Auckland, 1051, New Zealand

Location

Haukeland Universitetssykehus

Bergen, N-5021, Norway

Location

Akershus Universitetssykehus HF

Lørenskog, 1478, Norway

Location

Clin.Hosp.Med.Univ.Marcinkowski in Poznan

Poznan, 60-569, Poland

Location

Alergopneuma Medical Center

Świdnik, 21040, Poland

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

The Catholic University of Korea, Bucheon St.Mary's Hospital

Bucheon-si, 14647, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, 01757, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Soonchunhyang University Hospital Seoul

Seoul, 04401, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitari Vall D Hebron

Barcelona, 08035, Spain

Location

Hospital de Galdakao

Galdakao, 48960, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital Universitario De La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Clínico de Santiago

Santiago de Compostela, 15706, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

CTC Clinical Trial Consultants AB

Uppsala, 752 37, Sweden

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

Location

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Ramathibodi Hospital

Ratchathewi, 10400, Thailand

Location

Songklanagarind Hospital

Thailand, 90110, Thailand

Location

Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Castle Hill Hospital

Cottingham, Hull, HU16 5JQ, United Kingdom

Location

Royal Devon and Exeter Hospital, Wonford

Exeter, EX2 5DW, United Kingdom

Location

Royal Lancaster Infirmary

Lancaster, LA1 4RP, United Kingdom

Location

St James's University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41846682 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: September 5, 2024
• Primary Completion: November 25, 2025
• Study Completion: January 16, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

DK (2); JP (11); AU (7); SE (2); BE (2); US (15); MY (3); CN (14); KR (8); TH (4); HU (1); NZ (3); DE (12); AR (5); CA (4); FI (4); PL (2); SG (2); GB (8); FR (8); NO (2); ES (11); BR (7); CZ (2); IT (9); TW (5); GR (2)