Fibroneer-IPF: A clinical trial for people with IPF investigating the effects of study drug BI 1015550 on lung function

Upcoming study
Expected to open September 2022
This study is currently recruiting
Expected to close November 2023
This study is closed
This study closed in November 2023
We will update this page with study results when available.
Information on study results are included below
This study closed in November 2023

What next?

Original listing:

What next?

Original listing:

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 IPF. The aim is to understand if the study drug affects scarring, inflammation and slows the rate of lung function decline.

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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 IPF. 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 list below). Only the clinical trial team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.

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 our more about other research opportunities visit our research finder main page.

You may be able to join this study if all of these apply:

Aged 40 years or over

Diagnosis of IPF

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) ≥45% of predicted normal at the first assessment

You will not be able to join the study of any of the following applies:

Not having a diagnosis of IPF

Other clinically significant lung changes

An acute exacerbation within 3 months prior to 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.

Taking part in research has the potential  to make a difference for people who have PF now and for future generations.

Where does the study take place?

Study locations

Aberdeen

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

The summary on this page 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 and contact the researchers directly via:

unitedkingdom@bitrialsupport.com

This study is supported by

Boehringer Ingelheim
Study ID number:
NCT05321069

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