A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Drug: BI 1819479Drug: Placebo matching 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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.
Further exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 1819479 low dose treatment group BI 1819479 - BI 1819479 medium dose treatment group BI 1819479 - BI 1819479 high dose treatment group BI 1819479 - Placebo group Placebo matching 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 (76)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
The Medical Research Group
🇺🇸Fresno, California, United States
St. Francis Medical Institute
🇺🇸Clearwater, Florida, United States
SEC Clinical Research
🇺🇸Pensacola, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Advanced Pulmonary Research
🇺🇸Warren, Michigan, United States
Singing River Health
🇺🇸Ocean Springs, Mississippi, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, 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
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Launceston Respiratory & Sleep Centre
🇦🇺Launceston, Tasmania, Australia
Lung Research Victoria
🇦🇺Footscray, Victoria, Australia
Kepler Univ. Klinikum Linz
🇦🇹Linz, Austria
Klinik Penzing SMZ Baumgartner Hoehe
🇦🇹Vienna, Austria
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium
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
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
McGill University Health Centre (MUHC)
🇨🇦Montreal, Quebec, Canada
The Second Xiangya Hospital Of Central South University
🇨🇳Changsha, China
People's Hospital of Sichuan Province
🇨🇳Chengdu, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
🇨🇳Hangzhou, China
China Shenyang Chest Hospital
🇨🇳Shenyang, China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
🇨🇳Wuhan, China
Affiliated Hospital, Xuzhou Medical college
🇨🇳Xuzhou, China
University Hospital Bulovka
🇨🇿Prague, Czechia
Oulun yliopistollinen keskussairaala
🇫🇮Oulu, Finland
Tampereen yliopistollinen sairaala
🇫🇮Tampere, Finland
HOP Côte de Nacre
🇫🇷Caen, France
HOP Charles Nicolle
🇫🇷Rouen, France
Universitätsmedizin Greifswald
🇩🇪Greifswald, Germany
Klinikum der Universität München AÖR
🇩🇪München, Germany
Koranyi National Institute For Pulmonolgy
🇭🇺Budapest, Hungary
Osp. S. Giuseppe Fatebenefratelli
🇮🇹Milano, Italy
Tosei General Hospital
🇯🇵Aichi, Seto, Japan
University of Fukui Hospital
🇯🇵Fukui, Yoshida-gun, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
🇯🇵Osaka, Sakai, Japan
Kyorin University Hospital
🇯🇵Tokyo, Mitaka, Japan
Toho University Omori Medical Center
🇯🇵Tokyo, Ota-ku, Japan
Center Hospital of the National Center for Global Health and Medicine
🇯🇵Tokyo, Shinjuku-ku, Japan
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Institut Perubatan Respiratori
🇲🇾Kuala Lumpur, Malaysia
University Clinical Hospital in Bialystok I
🇵🇱Bialystok, Poland
Norbert Barlicki University Clinical Hospital No.1, Lodz
🇵🇱Lodz, Poland
Clin.Hosp.Med.Univ.Marcinkowski in Poznan
🇵🇱Poznan, Poland
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
🇵🇱Warszawa, Poland
Singapore General Hospital
🇸🇬Singapore, Singapore
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Vall d'Hebron-Barcelona-47683
🇪🇸Barcelona, Spain
Hospital de Galdakao
🇪🇸Galdakao, Spain
Hospital de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital La Princesa
🇪🇸Madrid, Spain
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Chulalongkorn Hospital
🇹🇭Bangkok, Thailand
Songklanagarind Hospital
🇹🇭Hat Yai, Thailand
Srinagarind Hospital
🇹🇭Khon Kaen, Thailand
Royal Lancaster Infirmary
🇬🇧Lancaster, United Kingdom
St James's University Hospital
🇬🇧Leeds, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom