A Phase 2, randomized, double-blind, placebo-controlled, parallel group study (TRANSFORM) to evaluate the efficacy and safety of GSK3915393 in participants with Idiopathic Pulmonary Fibrosis (IPF)
This research study, called TRANSFORM, is looking into a new medication, GSK3915393, for people living with Idiopathic Pulmonary Fibrosis (IPF). IPF is a long-term lung disease that causes scarring in the lungs, making it harder to breathe over time. In this study, we want to find out how well the new medicine works and if it is safe. Participants will be randomly given either the new medicine or a dummy pill (placebo) – neither they nor their doctors will know which one they are receiving. We will mainly be checking how their breathing changes over 26 weeks, using a measurement of lung capacity. We will also monitor for any side effects.
At a glance
What is this study about?
Idiopathic Pulmonary Fibrosis (IPF) is a serious lung condition where scar tissue builds up in your lungs, making them stiff and less able to take in oxygen. This can lead to symptoms like shortness of breath and a persistent cough, which can get worse over time. Currently, there are treatments that can help slow down the disease, but researchers are always looking for new and better ways to manage IPF.
This particular study, known as TRANSFORM, is a 'Phase 2' trial. This means that after initial checks, researchers are now looking more closely at whether a new medicine, GSK3915393, is effective and safe for people with IPF. The main goal is to see if this new medicine can improve how well your lungs work over 26 weeks, specifically by measuring how much air you can breathe out after taking a deep breath – this is called Forced Vital Capacity (FVC).
By comparing the new medicine to a dummy pill (placebo), the researchers hope to understand if GSK3915393 could become a helpful new treatment option for people living with IPF. Finding new treatments is incredibly important for improving the lives of those affected by this condition.
Key takeaways
- This study is testing a new drug (GSK3915393) for Idiopathic Pulmonary Fibrosis (IPF).
- It aims to see if the drug improves breathing and is safe over 26 weeks.
- Participants will receive either the new drug or a dummy pill.
- Regular clinic visits and health checks will be required for 26 weeks.
- Your lung function (breathing ability) will be a key measurement.
Who may be eligible?
To join this study, people must be 18 years old or older. The study is open to both men and women. There might be other health requirements too, such as specific medical test results, specific medications you may or may not be taking, or other health conditions that would prevent you from taking part.
The research team will carefully check your medical history and current health to make sure the study would be safe and suitable for you. They will explain all the specific requirements in detail if you are interested in potentially joining.
It's important that you meet all the criteria to ensure the study results are clear and that your safety is protected throughout the trial.
- Are you 18 years old or older?
- Do you have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF)?
- Are you able to attend regular clinic visits for 26 weeks?
- Are you willing to potentially receive either the study drug or a dummy pill?
- Are you not currently on other treatments that might interfere with the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be assigned to either receive the new study medicine, GSK3915393, or a dummy pill (placebo), meaning it contains no active medicine. Neither you nor your study doctor will know which one you are receiving – this is called 'double-blinded'. You will take the assigned tablet regularly throughout the study period.
You will have several regular visits to the study clinic over 26 weeks. During these visits, the research team will perform various tests and checks. This will include measuring your lung function (like how much air you can breathe out), taking blood and urine samples, checking your blood pressure, temperature, and pulse rate, and sometimes performing an ECG (a heart tracing). They will also ask you about your general health and any side effects you might be experiencing. After the 26 weeks, there might be a final follow-up visit or contact to check on your health.
Potential risks and benefits
Locations (6)
- —Germany
- —Italy
- —France
- —Poland
- —Spain
- —Netherlands
Common questions
What is Idiopathic Pulmonary Fibrosis (IPF)?
IPF is a lung condition where scar tissue builds up in your lungs, making it harder to breathe over time.
What is a 'Phase 2' study?
A Phase 2 study is an early stage of clinical research that looks more closely at whether a new medicine works and is safe for a specific condition.
What does 'double-blind' mean?
It means neither you nor your study doctor will know if you are receiving the new medicine or the dummy pill.
What is 'FVC'?
FVC stands for Forced Vital Capacity. It's a measurement of how much air you can breathe out after taking a deep breath, and it helps measure your lung function.
Can I stop participating in the study if I want to?
Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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