What next?
What next?
About this study
This study is a second step research trial involving patients with IPF taking a new drug called Leramistat.
The aim of this study is to see if Leramistat has an effect on lung function for people with IPF.
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 assigned to one of two groups. One group will receive a new drug called Leramistat, and the other group will receive a look alike drug in the form of a placebo. A placebo does not contain any of the active drug ingredients. You and the researchers will not know which group you have been assigned to until after the study has finished. This helps the researchers to understand what the true effects of the drug are.
At the beginning, the researchers will check if you're eligible to take part in the study. This will take around 1 to 4 weeks. During that time you may have tests to look at your lung function, walking distance, and potentially a CT scan.
If you qualify and decide to take part, you will receive either the Leramistat drug or a placebo for 12 weeks. During that time, the researchers will monitor you and you will have additional blood tests and breathing tests to look at your lung function, at the end of the study.
Summary of involvement
Maximum of 24 weeks participation
Taking either the new drug or the placebo for 12 weeks
Breathing tests to look at lung function
Blood tests
Can I take part?
You may be able to take part if you have a diagnosis of IPF and are aged 40 years and over. If you are currently receiving treatment for your IPF, such as the antifibrotic medication nintedanib or pirfenidone, then you must have been on a stable dose for at least 8 weeks.
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.
• Aged 40 or over.
• Diagnosis of IPF
• Lung function over 45%, measured with a breathing test.
• If medication is being taken, only those on nintedanib or pirfenidone and on a stable dose of either for at least 8 weeks before the study.
• Expected lifespan over 1 year to be able to participate in the study fully
• Emphysema effecting ≥50% of the lungs, or if the emphysema is more extensive than the fibrosis.
• Current or previous history of cancer within the last 5 years
• Abnormal heart rate, blood pressure or ECG during tests at your first visit
• Significant history of strong drug allergies or allergic reactions
• History of chronic or recurring infections
• Diagnosis of severe chronic obstructive pulmonary disease (COPD) or asthma
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.
Where does the study take place?
Study locations
London
Manchester
Walsall
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
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.
info@istesso.co.ukThis 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