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

Phase 2

Active, not recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Placebo matching BI 1819479; Drug: BI 1819479

• Registration Number: NCT06335303
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-22
• Study First Posted: 2024-03-28
• Study Start: 2024-09-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-12-03
• Study Completion: 2026-02-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo matching BI 1819479	-
BI 1819479 low dose treatment group	BI 1819479	-
BI 1819479 medium dose treatment group	BI 1819479	-
BI 1819479 high dose treatment group	BI 1819479	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Absolute change from baseline in FVC at Week 24 [in milliLiter]	At baseline and at week 24

Trial Locations

Locations (164)

CEDIC - Centro de Investigacion Clinica; 🇦🇷 Caba, Argentina

Centro de Investigación Clinica Belgrano; 🇦🇷 Caba, Argentina

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

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

Brussels - UNIV Saint-Luc; 🇧🇪 Bruxelles, Belgium

Liège - HOSP 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; 🇧🇷 Goiania, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre; 🇧🇷 Porto Alegre, Brazil

Pesquisare; 🇧🇷 Santo André, Brazil

Hospital Alemao Oswaldo Cruz; 🇧🇷 Sao Paulo, Brazil

COE Sao Jose dos Campos; 🇧🇷 SJC, 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; 🇨🇳 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

HOP Charles Nicolle; 🇫🇷 Rouen, 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; 🇩🇪 Hannover, Germany

Lungenklinik Hemer; 🇩🇪 Hemer, Germany

Lungenfachklinik Immenhausen; 🇩🇪 Immenhausen, Germany

Klinikum Konstanz; 🇩🇪 Konstanz, Germany

Universität Leipzig; 🇩🇪 Leipzig, Germany

Klinikum der Universität München AÖR; 🇩🇪 München, Germany

Univ. Gen. Hosp. of Ioannina; 🇬🇷 Ioannina, Greece

Univ. Gen. Hosp. of Patras; 🇬🇷 Patras, Greece

Hospital of Heraklion (PAGNI); 🇬🇷 Voutes, Greece

University of Debrecen Clinical Centre; 🇭🇺 Debrecen, Hungary

A. O. Universitaria Careggi; 🇮🇹 Firenze, Italy

Ospedale Colonnello D Avanzo; 🇮🇹 Foggia, Italy

Ospedale G.B. Morgagni; 🇮🇹 Forli', Italy

Azienda Ospedaliera San Martino; 🇮🇹 Genova, Italy

Ospedale Classificato San Giuseppe; 🇮🇹 Milano, Italy

Azienda Ospedaliera Universitaria di Padova; 🇮🇹 Padova, 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

The Catholic University of Korea, Bucheon St.Mary's Hospital; 🇰🇷 Bucheon, Korea, Republic of

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Inje University Sanggye Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang University Hospital Seoul; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

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; 🇵🇱 Swidnik, Poland

Singapore General Hospital; 🇸🇬 Singapore, Singapore

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital de Galdakao; 🇪🇸 Galdakao, Spain

Hospital de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Spain

Hospital La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Virgen de la Victoria; 🇪🇸 Malaga, 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; 🇪🇸 Sevilla, Spain

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

CTC Clinical Trial Consultants AB; 🇸🇪 Uppsala, Sweden

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Chang Gung Memorial Hospital(Linkou); 🇨🇳 TaoYuan, Taiwan

Chulalongkorn Hospital; 🇹🇭 Bangkok, Thailand

Songklanagarind Hospital; 🇹🇭 Hat Yai, Thailand

Srinagarind Hospital; 🇹🇭 Khon Kaen, Thailand

Ramathibodi Hospital; 🇹🇭 Ratchathewi, 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