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NCT06335303

PHASE2

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

322

Start Date

2024-09-05

Completion Date

2026-01-16

Last Updated

2026-07-27

Healthy Volunteers

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

DRUG

BI 1819479

DRUG

Placebo matching BI 1819479

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.

Locations (163)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Critical Care, Pulmonary and Sleep Associates

Lakewood, Colorado, United States

Clinical Research Specialists LLC - Kissimmee

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

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, Argentina

Hospital Britanico de Buenos Aires

CABA, Argentina

Centro de Investigación Clinica Belgrano

CABA, Argentina

CEDIC - Centro de Investigacion Clinica

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

Graz, Austria

Krems University Hospital

Krems, Austria

Johannes Kepler University 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

Cliniques Universitaires Saint-Luc

Brussels, Belgium

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

Goiânia, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

Pesquisare

Santo André, Brazil

COE Sao Jose dos Campos

São José dos Campos, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, 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, Sichuan University

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

University Thomayer´s 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

Hôpital Louis Pradel

Bron, France

HOP CHU Caen

Caen, France

INS Coeur Poumon

Lille, France

HOP Nord

Marseille, France

Hopital Pasteur

Nice, France

HOP Pontchaillou

Rennes, France

Pneumologische Praxis Dr. Löh

Bad Homburg, Germany

Charité - Universitätsmedizin Berlin

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

Hanover, Germany

Lungenklinik Hemer

Hemer, Germany

Lungenfachklinik Immenhausen

Immenhausen, Germany

Klinikum Konstanz

Konstanz, Germany

Universität Leipzig

Leipzig, Germany

Klinikum der Universität München AÖR

München, Germany

Hospital of Heraklion (PAGNI)

Crete, Greece

Univ. Gen. Hosp. of Ioannina

Ioannina, Greece

University of Debrecen Clinical Centre

Debrecen, Hungary

A. O. Universitaria Careggi

Florence, Italy

Ospedale Colonnello D Avanzo

Foggia, Italy

Ospedale G.B. Morgagni

Forlì, Italy

Azienda Ospedaliera San Martino

Genova, Italy

Ospedale Classificato San Giuseppe

Milan, Italy

Azienda Ospedaliera Universitaria di Padova

Padova, Italy

Pol. Universitario Tor Vergata

Roma, Italy

And 63 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (163)