What next?
What next?
About this study
This study is a proof of clinical concept investigation to understand the effects of a new drug, BI 1819479, on the changes in lung function test results for people with idiopathic pulmonary fibrosis (IPF).
New treatments are needed that further reduce the decline in lung function, positively affect symptoms and improve quality of life for people with IPF. This trial will investigate the drug, BI 1819479, and to be used as stand-alone treatment, or in addition to standard care of taking antifibrotic medication.
This study aims to test whether BI 1819479 improves lung function in people with idiopathic pulmonary fibrosis (IPF).
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
What is involved?
Approximately 300 people will take part across the world. You will be assigned to one of four treatment groups. This will either be the study drug (at varying doses) or a placebo. A placebo is an alternative, which looks exactly like the study drug tablets, but it contains no active medication. This helps researchers to understand the true effects of the drug. The treatment will last from 6 months to 1 year.
Study Steps for People Taking Part:
Initial Screening: After signing consent, you will attend an initial visit to assess if you are suitable to take part in the study. This may include clinical tests over 1–6 weeks.
Randomisation: People who meet the criteria and are suitable to take part, will then be randomly assigned into one of the four groups.
Treatment Phase: Each person taking part will receive treatment daily for at least 6 months, with options for extended treatment up to one year.
Regular study visits are scheduled every 8 weeks to monitor health and treatment response.
End of Treatment: Once the last person who signs up to take part completes 6 months, all ongoing participants will finish treatment and have an End-of-Treatment visit to the hospital, followed by a follow-up visit 8 weeks later.
You will also have regular assessments, including high-resolution CT (HRCT) imaging, safety evaluations, and clinical assessments to track you response to taking the drug.
Summary of involvement
Taking the drug or a placebo for at least 6 months and up to 1 year
Regular hospital visits
Clinical assessments and tests
Can I take part?
You may be able to take part if you are aged 40 years and older, and have a diagnosis of IPF.
In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the research team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point without this effecting your usual care or treatment.
If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.
To find out more about other research opportunities visit our research finder main page.
Aged 40 years and older
Diagnosis of IPF based on the 2022 ATS/ERS/JRS/ALAT Guideline [P22-03204]
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
Lung function test requirements which will be assessed by the research team
Acute exacerbation of IPF within the last 12 weeks
Treated with immunosuppressive medications (other than oral corticosteroids) or more than 15 mg/day of prednisone
Lower respiratory tract infection requiring treatment within the last 4 weeks
What difference could taking part make?
Taking part in this study will help researchers to understand the effect of BI 1819479 for people with IPF. Taking part in research has the potential to help people understand more about their condition, have more in depth monitoring and also help people in the future who have IPF.
Where does the study take place?
Study locations
London
Birmingham
Leeds
Exeter
Hull
Oxford
Manchester
Southampton
Lancaster
Please note that some locations are not yet open to recruitment, but will be soon.
How to take part
Please speak to your healthcare team, if you are interested in taking part in research.
Further information
This page is a summary which provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.
If you have any questions about this research study, please speak to your medical team.
clintriage.rdg@boehringer-ingelheim.comThis study is supported by
APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.
Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org