What next?
The results showed that the group of participants who were given the higher treatment dose during the trial had slower decline in their lung function compared to the group of people who did not receive the treatment.
People who took the drug tolerated it well and there was a low dropout rate for people who stopped taking the drug due to adverse side effects.
The results were similar for people with progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF).
This was a phase 2 study and the results supported the drug moving to a phase 3 clinical trial. This will be in a larger number of people, where researchers will be able to understand more about the safety and effectiveness of the treatment.
For more information about the results of this phase 2 study, you can read the study sponsor press releases for the IPF group and the PPF group.
What next?
The results showed that the group of participants who were given the higher treatment dose during the trial had slower decline in their lung function compared to the group of people who did not receive the treatment.
People who took the drug tolerated it well and there was a low dropout rate for people who stopped taking the drug due to adverse side effects.
The results were similar for people with progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF).
This was a phase 2 study and the results supported the drug moving to a phase 3 clinical trial. This will be in a larger number of people, where researchers will be able to understand more about the safety and effectiveness of the treatment.
For more information about the results of this phase 2 study, you can read the study sponsor press releases for the IPF group and the PPF group.
About this study
Researchers discovered that there is a marker, called lysophospholipid lysophosphatidic acid (LPA), within the lungs that is shown to be increased and related to the development of pulmonary fibrosis.
Injury to the lungs stimulates this to be made, ultimately leading to scarring of the lungs. A new drug, BMS-986278, which is thought to block this process could help people with pulmonary fibrosis.
In this study, researchers aim to find out if the new drug is safe and effective to potentially help treat pulmonary fibrosis.
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?
You will be randomly put into 1 of 3 groups.
- Group 1 will be given 30 mg of the study drug twice daily
- Group 2 will be given 60 mg of the study drug twice daily
- Group 3 will be given a placebo. This is a look alike treatment and will not contain any of the study drug.
At different time points within the study, you will have breathing tests to measure your lung function, and other medical tests.
There will be an option to continue the treatment for an additional 26 week.
Summary of involvement
Participation for 26 weeks, with optional extension of taking the drug
Assigned to one of three groups, to either receive the study drug or a placebo
Breathing tests
Other medical tests
Can I take part?
You may be able to take part if you have a diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). You must me aged 40 years and over if you have a diagnosis of IPF, or aged 21 years and over if you have a diagnosis of PPF. You can still take part if you are currently receiving treatment for your PF, such as the antifibrotic medication nintedanib or pirfenidone.
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.
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.
Diagnosis of IPF or PPF
Aged 40 years and over for IPF
Aged 21 years and over for PPF
Active smoker
Women of childbearing potential
Cancer within the last 5 years
What difference could taking part make?
Taking part in research provides the opportunity to have an active involvement in your healthcare, help you to understand the disease more and the effects it has on your day to day life. Research studies, such as this, have the potential to help develop new treatment options that could help improve the quality of people’s lives for those with PF, both now and in the future.
Taking part in this study will help researchers to understand if the new drug could be an effective treatment option which slows down lung function decline.
Where does the study take place?
Study locations
Cambridge
Edinburgh
London
How to take part
Please speak to your medical team about taking part, or contact the research team directly, to express your interests.
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.
Clinical.Trials@bms.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