What next?
What next?
About this study
Idiopathic Pulmonary Fibrosis (IPF) is a chronic lung disease in which scar tissue builds-up in the lungs and can cause significant difficulty with breathing. People with IPF can have high levels of an enzyme called tissue transglutaminase 2 (TG2) in their lungs. GSK3915393 is a new drug, which is being tested to see if it can help people with IPF. The drug is thought to work by blocking the action of TG2 enzymes in the lung. Researchers think that this may help to reduce further lung damage in IPF.
In this study, researchers aim to evaluate the safety and effectiveness of GSK3915393 in people with IPF. They will test to see if GSK3915393 can help slow down the reduction of lung health decline.
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?
At the start of the trial, you will have assessments and a review of your medical history to find out if taking part is right for you and that you meet the criteria for who is suitable for the trial.
If the TRANSFORM trial is right for you and you decide to take part, you will be asked to take the GSK3915393 drug or a placebo for six months. A placebo will look like the GSK3915393, but will not contain any active ingredient; it is sometimes referred to as a dummy drug.
This study is a double-blind trial. This means that you won't be told if you are receiving the study drug or a placebo. The study is set up in a way that your doctor won't know which group you are in until the end of the study. This is so that the results aren't accidently influenced in any way.
To help researchers understand more about the drug and its impact you will be asked to have various medical assessments and to complete questionnaires throughout the trial.
Summary of involvement
Taking part in the study for 6 months
Taking either the study drug or a placebo tablet daily
Medical assessments including lung function tests
Questionnaires
Can I take part?
You may be able to take part in this study if you have a diagnosis of IPF within the last 5 years.
In addition to the main points below, there are other inclusion and exclusion points which the researchers will access and determine at your baseline assessment.
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.
You have a diagnosis of IPF within the last 5 years
You have had a HRCT scan within the last 12 months
You are not currently taking antifibrotic medication (pirfenidone or nintedanib)
You have a body mass index (BMI) within the range of 18.5-35 kg/m2
You have an interstitial lung disease (ILD) associated with a known cause
You have a diagnosis of sarcoidosis or any systemic autoimmune disease
You have had an acute exacerbation within the last 6 months
You have had a lung transplant or recent major surgery
You smoke cigarettes (including e-cigarettes) either currently or within the last 3 months
What difference could taking part make?
At the moment there are few ways of slowing down the progression of pulmonary fibrosis. New research studies, such as this clinical trial, are needed to gain valuable knowledge to help find better and more effective treatment options. Taking part in research has the potential to help future people who face a diagnosis of pulmonary fibrosis. Each research study enables us to learn more and more about the disease.
Where does the study take place?
Study locations
Edinburgh
Leeds
London
How to take part
If you would like more information about taking part in research, please speak to your healthcare team about the options that are available to you.
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.
This 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.
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 ensure that these details are correct and are kept up to date. If you are aware of any inaccuracies, please email research@actionpf.org