What next?
The results showed that nerandomilast slowed the decline in lung function over one year in people living with progressive pulmonary fibrosis. This development could mark the first new treatment for over a decade, potentially transforming care for thousands of people across the UK and globally. Whilst the new drug doesn’t stop progression of disease, it offers hope as an additional treatment option that may be tolerated by more people.
More than 1,100 people across 44 countries took part in the trial. Participants who received nerandomilast experienced a significantly smaller decline in lung function compared to those who received a placebo. Importantly, the drug showed effectiveness both as a standalone therapy and when used alongside existing treatments.
While participants experienced some degree of lung function decline, reinforcing the need for ongoing research, the slowed progression seen in those taking nerandomilast is a substantial and encouraging step forward.
The most commonly reported side effect was diarrhoea. However, fewer than 1 in 25 participants stopped treatment because of it, indicating the drug was generally well tolerated. This is a significant difference compared to current treatments, where many have to stop taking the drug due to the impact of this and other side effects. You can find out more about the results from the Boehringer Ingelheim press release.
Next steps?
People who completed the trial have been offered the opportunity to continue taking nerandomilast in a long-term follow-up study.
We are excited to see the impact of nerandomilast for IPF and other forms of PF. APF is committed to working closely with stakeholders, including the drug company and regulatory bodies, to ensure this potential treatment reaches the people who need them as soon as possible. The medication will still need to go through the drug approval processes in the UK before it is available.
We will continue to provide updates when we know more.
What next?
The results showed that nerandomilast slowed the decline in lung function over one year in people living with progressive pulmonary fibrosis. This development could mark the first new treatment for over a decade, potentially transforming care for thousands of people across the UK and globally. Whilst the new drug doesn’t stop progression of disease, it offers hope as an additional treatment option that may be tolerated by more people.
More than 1,100 people across 44 countries took part in the trial. Participants who received nerandomilast experienced a significantly smaller decline in lung function compared to those who received a placebo. Importantly, the drug showed effectiveness both as a standalone therapy and when used alongside existing treatments.
While participants experienced some degree of lung function decline, reinforcing the need for ongoing research, the slowed progression seen in those taking nerandomilast is a substantial and encouraging step forward.
The most commonly reported side effect was diarrhoea. However, fewer than 1 in 25 participants stopped treatment because of it, indicating the drug was generally well tolerated. This is a significant difference compared to current treatments, where many have to stop taking the drug due to the impact of this and other side effects. You can find out more about the results from the Boehringer Ingelheim press release.
Next steps?
People who completed the trial have been offered the opportunity to continue taking nerandomilast in a long-term follow-up study.
We are excited to see the impact of nerandomilast for IPF and other forms of PF. APF is committed to working closely with stakeholders, including the drug company and regulatory bodies, to ensure this potential treatment reaches the people who need them as soon as possible. The medication will still need to go through the drug approval processes in the UK before it is available.
We will continue to provide updates when we know more.
About this study
People affected by pulmonary fibrosis (PF) currently have limited treatment options to slow the progression of disease. New research studies are needed to gain valuable knowledge about potentially better treatment options.
The Fibroneer trial is a randomised controlled trial, designed to see if a medicine called BI 1015550 can help people with PF-ILD. The aim is to understand if the study drug affects scarring, inflammation and slows the rate of lung function decline.
PF-ILD is a group of progressive fibrotic interstitial lung diseases, that includes diagnoses such as: fibrotic hypersensitivity pneumonitis (fHP), rheumatoid arthritis interstitial lung disease (RA-ILD), and many others.
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?
Patients will be randomly assigned to one of three groups, by chance. Participants will not know which group they have been assigned to until the end of the study. Patients who are assigned to 2 of the groups will be given different doses of BI 1015550 (either a higher or lower dose). Patients will take a tablet twice per day. Patients who are in the third group will receive a placebo. Patients in this group will still take tablets twice per day, however these tablets will not contain any of the BI 1015550 study drug.
Patients will be asked to take part in the trial for up to two and a half years. Throughout the first year, patients will visit the study location 10 times. After the first year, study visits will be once every 3 months. During these visits various test will be carried out, including blood tests, lung function tests and completing questionnaires.
Summary of involvement
Participation for up to 2.5 years
10 assessments during the first year and 3-monthly thereafter
Taking a study drug or placebo
Medical assessments
Patient surveys
Can I take part?
You may be eligible to take part if you are aged 40 years or older and have a diagnosis of progressive fibrotic ILD (PF-ILD). If you have IPF and would like to take part, please follow this link:
If you are already receiving treatment in the form of nintedanib or pirfenidone, you can continue taking this throughout the trial.
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 the main criteria 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 or over
Diagnosis of PF-ILD
Either:
On stable therapy with nintedanib or pirfenidone for at least 12 weeks prior to the first assessment
Or
Not receiving treatment with nintedanib or pirfenidone for at least 8 weeks prior to the first assessment
Forced Vital Capacity (FVC) more than 45% of predicted normal at the first assessment
Not having a diagnosis of PF-ILD
Other clinically significant lung changes
An acute exacerbation within 3 months before the first assessment
Confirmed infection of COVID-19 which is not fully recovered within 4 weeks before randomisation.
What difference could taking part make?
Taking part in the Fibroneer clinical trial will help researchers to identify the potential effects of a new study drug. The study will help to gain greater understanding of the medication and if it has the potential to help reduce the progression of lung scarring.
Where does the study take place?
Study locations
Aberdeen
Bristol
Exeter
Leeds
London
Southampton
Multiple study centres across the UK are currently recruiting patients. Patients who do not live locally to a trial site may still be eligible to take part.
How to take part
To find out more information about taking part in the Fibroneer trial, please contact: Boehringer Ingelheim, Tel: 08000514022, Email: unitedkingdom@bitrialsupport.com
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.
unitedkingdom@bitrialsupport.comThis study is supported by
This page provides a lay summary of the research study and does not contain all the information needed to inform decisions about taking part. Please speak to your medical team or the study research team in relation to specific details about the study.
Action for Pulmonary Fibrosis does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators. Every effort is made to ensure that these details are correct and are kept up to date. If you are aware of any inaccuracies, please email research@actionpf.org