EU-IPFF committed to promoting research in Pulmonary Fibrosis

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06335303
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Boehringer Ingelheim
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Malaysia, New Zealand, Norway, Poland, Singapore, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis
Study Website:	View Trial Website

Arms & Interventions

Arms

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

Interventions

Drug: - BI 1819479

BI 1819479

Drug: - Placebo matching BI 1819479

Placebo matching BI 1819479

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The Medical Research Group, Fresno, California

Status

Not yet recruiting

Address

The Medical Research Group

Fresno, California, 93720

Site Contact

Boehringer Ingelheim

Clinical Trial Finder