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New pill aims to slow lung scarring in IPF patients

NCT ID NCT06335303

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This study tests an experimental oral drug, BI 1819479, in 322 adults with idiopathic pulmonary fibrosis (IPF). Participants receive one of three doses or a placebo for 6 to 12 months. The main goal is to see if the drug can slow the yearly decline in lung function, measured by breathing tests. The study is completed, and results will help determine if further testing is warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 1819479 (an oral drug)
What this could lead to
If it works, this could point toward a new treatment to slow lung function decline in people with IPF.
What could go wrong
This is a Phase 2 dose-finding study, so it is still early. The drug may not work better than placebo, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

322 people

The number who actually took part.

Started

Sep 2024

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis

Contacts and locations

Locations

  • A. O. Universitaria Careggi

    Florence, 50137, Italy

  • Advanced Pulmonary Research

    Warren, Michigan, 48088, United States

  • Affiliated Hospital, Xuzhou Medical college

    Xuzhou, 221009, China

  • Akershus Universitetssykehus HF

    Lørenskog, 1478, Norway

  • Anhui Provincial Hospital

    Hefei, 230001, China

  • Aotearoa Clinical Trials

    Papatoetoe, Auckland, 2025, New Zealand

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera San Martino

    Genova, 16132, Italy

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

    Roma, 00189, Italy

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128, Italy

  • Beijing Chao-Yang Hospital

    Beijing, 100020, China

  • CEDIC - Centro de Investigacion Clinica

    CABA, C1060ABN, Argentina

  • CHR de la Citadelle

    Liège, 4000, Belgium

  • COE Sao Jose dos Campos

    São José dos Campos, 122241-660, Brazil

  • CTC Clinical Trial Consultants AB

    Uppsala, 752 37, Sweden

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605, Australia

  • Caritas-Krankenhaus St. Maria gGmbH

    Donaustauf, 99093, Germany

  • Castle Hill Hospital

    Cottingham, Hull, HU16 5JQ, United Kingdom

  • Centro de Investigaciones Metabolicas (CINME)

    C.a.b.a, 1056, Argentina

  • Centro de Investigación Clinica Belgrano

    CABA, 1425, Argentina

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333, Taiwan

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • China Shenyang Chest Hospital

    Shenyang, 110000, China

  • Chulalongkorn Hospital

    Bangkok, 10330, Thailand

  • Churchill Hospital

    Oxford, OX3 7LJ, United Kingdom

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

    Poznan, 60-569, Poland

  • Clinic Floridsdorf

    Vienna, 1210, Austria

  • Clinical Research Associates of Central PA

    DuBois, Pennsylvania, 15801, United States

  • Clinical Research Specialists LLC - Kissimmee

    Kissimmee, Florida, 34746, United States

  • Clinical Trials Center of Middle Tennessee, LLC

    Franklin, Tennessee, 37067, United States

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

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

    New Bern, North Carolina, 28562, United States

  • Consultorios Médicos del Buen Ayre

    Capital Federal, 1425, Argentina

  • Critical Care, Pulmonary and Sleep Associates

    Lakewood, Colorado, 80228, United States

  • Faculdade de Medicina de Botucatu - UNESP

    Botucatu, 18618-687, Brazil

  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120, China

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168, Italy

  • Greenlane Clinical Centre

    One Tree Hill, Auckland, 1051, New Zealand

  • HOP Avicenne

    Bobigny, 93000, France

  • HOP CHU Caen

    Caen, 14033, France

  • HOP Nord

    Marseille, 13915, France

  • HOP Pontchaillou

    Rennes, 35033, France

  • HOP d'Angers

    Angers, 49933, France

  • HYKS Keuhkosairauksien tutkimusyksikkö

    Helsinki, 00029, Finland

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192, Japan

  • Hangzhou First People's Hospital

    Hangzhou, 310006, China

  • Haukeland Universitetssykehus

    Bergen, N-5021, Norway

  • Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • Hopital Pasteur

    Nice, 06001, France

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01327-001, Brazil

  • Hospital Britanico de Buenos Aires

    CABA, 1280AEB, Argentina

  • Hospital Central de Asturias

    Oviedo, 33011, Spain

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706, Spain

  • Hospital Elisabethinen Linz

    Linz, Austria

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital Sultan Idris Shah Serdang

    Kajang, 43000, Malaysia

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907, Spain

  • Hospital Universitario De La Princesa

    Madrid, 28006, Spain

  • Hospital Universitario Infanta Leonor

    Madrid, 28031, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Virgen del Rocío

    Seville, 41013, Spain

  • Hospital das Clínicas da UFG - EBSERH

    Goiânia, 74605-050, Brazil

  • Hospital de Galdakao

    Galdakao, 48960, Spain

  • Hospital of Heraklion (PAGNI)

    Crete, 71500, Greece

  • Hôpital Louis Pradel

    Bron, 69677, France

  • INS Coeur Poumon

    Lille, 59037, France

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Inje University Sanggye Paik Hospital

    Seoul, 01757, South Korea

  • Institut Perubatan Respiratori

    Kuala Lumpur, 53000, Malaysia

  • Institute for Respiratory Health

    Nedlands, Western Australia, 6009, Australia

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90035-074, Brazil

  • Johannes Kepler University Linz

    Linz, 4020, Austria

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051, Japan

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Karolinska University Hospital

    Stockholm, 171 76, Sweden

  • Klinikum Fulda gAG

    Fulda, 36043, Germany

  • Klinikum Konstanz

    Konstanz, 78464, Germany

  • Klinikum Region Hannover GmbH

    Hanover, 30459, Germany

  • Klinikum Wels - Grieskirchen GmbH

    Wels, 4600, Austria

  • Klinikum der Universität München AÖR

    München, 81377, Germany

  • Krems University Hospital

    Krems, 3500, Austria

  • Kyorin University Hospital

    Tokyo, Mitaka, 181-8611, Japan

  • Kyung Hee University Hospital

    Seoul, 02447, South Korea

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

  • Launceston Respiratory & Sleep Centre

    Launceston, Tasmania, 7250, Australia

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina, 29406, United States

  • Lung Research Victoria

    Footscray, Victoria, 3011, Australia

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376, Germany

  • Lungenklinik Hemer

    Hemer, 58675, Germany

  • Macquarie University

    Macquarie Park, 2109, Australia

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1, Canada

  • Medical University of Graz

    Graz, 8036, Austria

  • Memorial Hospital Gulfport

    Gulfport, Mississippi, 39501, United States

  • Nanjing Drum Tower Hospital

    Nanjing, 210008, China

  • National Center for Global Health and Medicine

    Tokyo, Shinjuku-ku, 162-8655, Japan

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Osaka, Sakai, 591-8555, Japan

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Odense University Hospital

    Odense, 5000, Denmark

  • Ospedale Classificato San Giuseppe

    Milan, 20123, Italy

  • Ospedale Colonnello D Avanzo

    Foggia, 71100, Italy

  • Ospedale G.B. Morgagni

    Forlì, 47121, Italy

  • Oulun yliopistollinen keskussairaala

    Oulu, 90220, Finland

  • People's Hospital of Sichuan Province

    Chengdu, 610072, China

  • Pesquisare

    Santo André, 09080-110, Brazil

  • Pneumologische Praxis Dr. Löh

    Bad Homburg, 61350, Germany

  • Pol. Universitario Tor Vergata

    Roma, 00133, Italy

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

    Świdnik, 21040, Poland

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23230, United States

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7, Canada

  • Ramathibodi Hospital

    Ratchathewi, 10400, Thailand

  • Rigshospitalet-København Ø-69883

    København Ø, 2100, Denmark

  • Royal Brompton Hospital

    London, SW3 6NP, United Kingdom

  • Royal Devon and Exeter Hospital, Wonford

    Exeter, EX2 5DW, United Kingdom

  • Royal Lancaster Infirmary

    Lancaster, LA1 4RP, United Kingdom

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • SEC Clinical Research

    Pensacola, Florida, 32503, United States

  • Sarawak General Hospital

    Kuching, Sarawak, 93586, Malaysia

  • Seoul National University Bundang Hospital

    Seongnam, 13620, South Korea

  • Serviços Medicos Respirar Sul Fluminense

    Barra Mansa, 27323240, Brazil

  • Severance Hospital

    Seoul, 03722, South Korea

  • Singapore General Hospital

    Singapore, 169608, Singapore

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

    Hangzhou, 310016, China

  • Songklanagarind Hospital

    Thailand, 90110, Thailand

  • Soonchunhyang University Hospital Seoul

    Seoul, 04401, South Korea

  • Southeastern Research Center-Winston Salem-69289

    Winston-Salem, North Carolina, 27103, United States

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303, United States

  • Srinagarind Hospital

    Khon Kaen, 40002, Thailand

  • St James's University Hospital

    Leeds, LS9 7TF, United Kingdom

  • Standort Penzing der Klinik Ottakring

    Vienna, 1140, Austria

  • TYKS

    Turku, 20520, Finland

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Tampereen yliopistollinen sairaala

    Tampere, 33520, Finland

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

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

    Bucheon-si, 14647, South Korea

  • The Iowa Clinic, PC

    West Des Moines, Iowa, 50266, United States

  • The Second Xiangya Hospital Of Central South University

    Changsha, 410011, China

  • Tianjin Medical University General Hospital

    Tianjin, 30052, China

  • Toho University Omori Medical Center

    Tokyo, Ota-ku, 143-8541, Japan

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503, Japan

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

    Wuhan, 430022, China

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2, Canada

  • Tosei General Hospital

    Aichi, Seto, 489-8642, Japan

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45 500, Greece

  • University Hospital Bulovka

    Prague, 18081, Czechia

  • University Thomayer´s Hospital

    Prague, 140 59, Czechia

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Calgary

    Calgary, Alberta, T2N 4Z6, Canada

  • University of Debrecen Clinical Centre

    Debrecen, 4032, Hungary

  • University of Fukui Hospital

    Fukui, Yoshida-gun, 910-1193, Japan

  • Universität Leipzig

    Leipzig, 04103, Germany

  • Universitätsklinikum Bonn AöR

    Bonn, 53127, Germany

  • Universitätsmedizin Greifswald

    Greifswald, 17475, Germany

  • Waikato Hospital

    Hamilton, 3240, New Zealand

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Wythenshawe Hospital

    Manchester, M23 9LT, United Kingdom

  • Zhejiang Hospital

    Hangzhou, 310013, China

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