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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06335303
Registration number
NCT06335303
Ethics application status
Date submitted
22/03/2024
Date registered
28/03/2024
Date last updated
14/10/2025
Titles & IDs
Public title
A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
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Scientific 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)
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Secondary ID [1]
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2023-508395-11-00
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Secondary ID [2]
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1462-0004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BI 1819479
Treatment: Drugs - Placebo matching BI 1819479
Experimental: BI 1819479 low dose treatment group -
Experimental: BI 1819479 medium dose treatment group -
Experimental: BI 1819479 high dose treatment group -
Placebo comparator: Placebo group -
Treatment: Drugs: BI 1819479
BI 1819479
Treatment: Drugs: Placebo matching BI 1819479
Placebo matching BI 1819479
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Annual rate of decline in Forced Vital Capacity (FVC) [milliLiter/year]
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Assessment method [1]
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Timepoint [1]
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Up to 52 weeks
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Secondary outcome [1]
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Absolute change from baseline in FVC at Week 24 [in milliLiter]
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Assessment method [1]
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Timepoint [1]
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At baseline and at week 24
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Eligibility
Key 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.
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/09/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
9/01/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
322
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,TAS,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Garran
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Royal Prince Alfred Hospital - Camperdown
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Launceston Respiratory & Sleep Centre - Launceston
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Lung Research Victoria - Footscray
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Austin Hospital - Heidelberg
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The Alfred Hospital - Melbourne
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Institute for Respiratory Health - Nedlands
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Macquarie University - Macquarie Park
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2605 - Garran
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2050 - Camperdown
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7250 - Launceston
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3011 - Footscray
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3084 - Heidelberg
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3004 - Melbourne
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6009 - Nedlands
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Recruitment postcode(s) [8]
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2109 - Macquarie Park
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Recruitment outside Australia
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Manchester
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06335303
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Boehringer Ingelheim
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1-800-243-0127
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
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Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'.
For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06335303
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