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Idiopathic Pulmonary FibrosisPhase 2NCT06335303

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

A Phase 2 study testing BI 1819479 in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 163 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
BI 1819479
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
322 participants
Where
163 sitesin 28 countries
Study dates
5 Sep 2024to 16 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 9Show fewer
  • 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.
  • Further exclusion criteria apply.

Trial locations and contacts

163 sites in 28 countries.

163 sites in 28 countries

United States15 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina, 29406

  • Clinical Research Associates of Central PA

    DuBois, Pennsylvania, 15801

  • Clinical Trials Center of Middle Tennessee, LLC

    Franklin, Tennessee, 37067

  • Memorial Hospital Gulfport

    Gulfport, Mississippi, 39501

  • Clinical Research Specialists LLC - Kissimmee

    Kissimmee, Florida, 34746

  • Critical Care, Pulmonary and Sleep Associates

    Lakewood, Colorado, 80228

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

    New Bern, North Carolina, 28562

  • SEC Clinical Research

    Pensacola, Florida, 32503

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23230

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Advanced Pulmonary Research

    Warren, Michigan, 48088

  • The Iowa Clinic, PC

    West Des Moines, Iowa, 50266

  • Southeastern Research Center-Winston Salem-69289

    Winston-Salem, North Carolina, 27103

Other trials in United States

China14 sites

  • Beijing Chao-Yang Hospital

    Beijing, 100020

  • The Second Xiangya Hospital Of Central South University

    Changsha, 410011

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • People's Hospital of Sichuan Province

    Chengdu, 610072

  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Hangzhou First People's Hospital

    Hangzhou, 310006

  • Zhejiang Hospital

    Hangzhou, 310013

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

    Hangzhou, 310016

  • Anhui Provincial Hospital

    Hefei, 230001

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • China Shenyang Chest Hospital

    Shenyang, 110000

  • Tianjin Medical University General Hospital

    Tianjin, 30052

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

    Wuhan, 430022

  • Affiliated Hospital, Xuzhou Medical college

    Xuzhou, 221009

Other trials in China

Germany12 sites

  • Pneumologische Praxis Dr. Löh

    Bad Homburg, 61350

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Universitätsklinikum Bonn AöR

    Bonn, 53127

  • Caritas-Krankenhaus St. Maria gGmbH

    Donaustauf, 99093

  • Klinikum Fulda gAG

    Fulda, 36043

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Klinikum Region Hannover GmbH

    Hanover, 30459

  • Lungenklinik Hemer

    Hemer, 58675

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Klinikum Konstanz

    Konstanz, 78464

  • Universität Leipzig

    Leipzig, 04103

  • Klinikum der Universität München AÖR

    München, 81377

Other trials in Germany

Japan11 sites

  • Tosei General Hospital

    Aichi, Seto, 489-8642

  • University of Fukui Hospital

    Fukui, Yoshida-gun, 910-1193

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Osaka, Sakai, 591-8555

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

  • Kyorin University Hospital

    Tokyo, Mitaka, 181-8611

  • Toho University Omori Medical Center

    Tokyo, Ota-ku, 143-8541

  • National Center for Global Health and Medicine

    Tokyo, Shinjuku-ku, 162-8655

Other trials in Japan

Spain11 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital de Galdakao

    Galdakao, 48960

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital Universitario De La Princesa

    Madrid, 28006

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Central de Asturias

    Oviedo, 33011

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

  • Hospital Virgen del Rocío

    Seville, 41013

Other trials in Spain

Italy9 sites

  • A. O. Universitaria Careggi

    Florence, 50137

  • Ospedale Colonnello D Avanzo

    Foggia, 71100

  • Ospedale G.B. Morgagni

    Forlì, 47121

  • Azienda Ospedaliera San Martino

    Genova, 16132

  • Ospedale Classificato San Giuseppe

    Milan, 20123

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128

  • Pol. Universitario Tor Vergata

    Roma, 00133

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

    Roma, 00189

Other trials in Italy

Australia8 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Lung Research Victoria

    Footscray, Victoria, 3011

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Launceston Respiratory & Sleep Centre

    Launceston, Tasmania, 7250

  • Macquarie University

    Macquarie Park, 2109

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Institute for Respiratory Health

    Nedlands, Western Australia, 6009

Other trials in Australia

France8 sites

  • HOP d'Angers

    Angers, 49933

  • HOP Avicenne

    Bobigny, 93000

  • Hôpital Louis Pradel

    Bron, 69677

  • HOP CHU Caen

    Caen, 14033

  • INS Coeur Poumon

    Lille, 59037

  • HOP Nord

    Marseille, 13915

  • Hopital Pasteur

    Nice, 06001

  • HOP Pontchaillou

    Rennes, 35033

Other trials in France

South Korea8 sites

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

    Bucheon-si, 14647

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Inje University Sanggye Paik Hospital

    Seoul, 01757

  • Kyung Hee University Hospital

    Seoul, 02447

  • Severance Hospital

    Seoul, 03722

  • Soonchunhyang University Hospital Seoul

    Seoul, 04401

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

United Kingdom8 sites

  • Heartlands Hospital

    Birmingham, B9 5SS

  • Castle Hill Hospital

    Cottingham, Hull, HU16 5JQ

  • Royal Devon and Exeter Hospital, Wonford

    Exeter, EX2 5DW

  • Royal Lancaster Infirmary

    Lancaster, LA1 4RP

  • St James's University Hospital

    Leeds, LS9 7TF

  • Royal Brompton Hospital

    London, SW3 6NP

  • Wythenshawe Hospital

    Manchester, M23 9LT

  • Churchill Hospital

    Oxford, OX3 7LJ

Other trials in United Kingdom

Austria7 sites

  • Medical University of Graz

    Graz, 8036

  • Krems University Hospital

    Krems, 3500

  • Johannes Kepler University Linz

    Linz, 4020

  • Hospital Elisabethinen Linz

    Linz

  • Standort Penzing der Klinik Ottakring

    Vienna, 1140

  • Clinic Floridsdorf

    Vienna, 1210

  • Klinikum Wels - Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Brazil7 sites

  • Serviços Medicos Respirar Sul Fluminense

    Barra Mansa, 27323240

  • Faculdade de Medicina de Botucatu - UNESP

    Botucatu, 18618-687

  • Hospital das Clínicas da UFG - EBSERH

    Goiânia, 74605-050

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90035-074

  • Pesquisare

    Santo André, 09080-110

  • COE Sao Jose dos Campos

    São José dos Campos, 122241-660

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01327-001

Other trials in Brazil

Argentina5 sites

  • Centro de Investigaciones Metabolicas (CINME)

    C.a.b.a, 1056

  • Hospital Britanico de Buenos Aires

    CABA, 1280AEB

  • Centro de Investigación Clinica Belgrano

    CABA, 1425

  • CEDIC - Centro de Investigacion Clinica

    CABA, C1060ABN

  • Consultorios Médicos del Buen Ayre

    Capital Federal, 1425

Other trials in Argentina

Taiwan5 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 10002

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

Other trials in Taiwan

Canada4 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

Other trials in Canada

Finland4 sites

  • HYKS Keuhkosairauksien tutkimusyksikkö

    Helsinki, 00029

  • Oulun yliopistollinen keskussairaala

    Oulu, 90220

  • Tampereen yliopistollinen sairaala

    Tampere, 33520

  • TYKS

    Turku, 20520

Other trials in Finland

Thailand4 sites

  • Chulalongkorn Hospital

    Bangkok, 10330

  • Srinagarind Hospital

    Khon Kaen, 40002

  • Ramathibodi Hospital

    Ratchathewi, 10400

  • Songklanagarind Hospital

    Thailand, 90110

Other trials in Thailand

Malaysia3 sites

  • Hospital Sultan Idris Shah Serdang

    Kajang, 43000

  • Institut Perubatan Respiratori

    Kuala Lumpur, 53000

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

Other trials in Malaysia

New Zealand3 sites

  • Waikato Hospital

    Hamilton, 3240

  • Greenlane Clinical Centre

    One Tree Hill, Auckland, 1051

  • Aotearoa Clinical Trials

    Papatoetoe, Auckland, 2025

Other trials in New Zealand

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • CHR de la Citadelle

    Liège, 4000

Other trials in Belgium

Czechia2 sites

  • University Thomayer´s Hospital

    Prague, 140 59

  • University Hospital Bulovka

    Prague, 18081

Other trials in Czechia

Denmark2 sites

  • Rigshospitalet-København Ø-69883

    København Ø, 2100

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

Greece2 sites

  • Hospital of Heraklion (PAGNI)

    Crete, 71500

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45 500

Other trials in Greece

Norway2 sites

  • Haukeland Universitetssykehus

    Bergen, N-5021

  • Akershus Universitetssykehus HF

    Lørenskog, 1478

Other trials in Norway

Poland2 sites

  • Clin.Hosp.Med.Univ.Marcinkowski in Poznan

    Poznan, 60-569

  • Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.

    Świdnik, 21040

Other trials in Poland

Singapore2 sites

  • Singapore General Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Sweden2 sites

  • Karolinska University Hospital

    Stockholm, 171 76

  • CTC Clinical Trial Consultants AB

    Uppsala, 752 37

Other trials in Sweden

Hungary1 site

  • University of Debrecen Clinical Centre

    Debrecen, 4032

Other trials in Hungary

About this study

Official title: 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.

Being tested
BI 1819479, Placebo matching BI 1819479
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 1819479Drug

    BI 1819479

  • Placebo matching BI 1819479Drug

    Placebo matching BI 1819479

Study groups in NCT06335303
Study groupRoleWhat they receive
BI 1819479 low dose treatment groupExperimentalNot described
Receives: Drug: BI 1819479
BI 1819479 medium dose treatment groupExperimentalNot described
Receives: Drug: BI 1819479
BI 1819479 high dose treatment groupExperimentalNot described
Receives: Drug: BI 1819479
Placebo groupPlacebo comparatorNot described
Receives: Drug: Placebo matching BI 1819479

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 52 weeks

Secondary outcomes (1)

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

    Measured: At baseline and at week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2024
  2. Study start5 Sep 2024
  3. Primary completion25 Nov 2025
  4. Study completion16 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
322 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06335303
Sponsor's protocol ID
1462-0004
Other IDs
2023-508395-11-00, U1111-1302-4283, 2023
Status last verified
Jul 2026
First submitted
22 Mar 2024
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41846682

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 1819479 in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 163 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in United States, China, Germany, Japan, Spain and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annual rate of decline in Forced Vital Capacity (FVC) [milliLiter/year] (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06335303, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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