What next?
What next?
About this study
People with idiopathic pulmonary fibrosis (IPF) often have difficulty breathing, experience shortness of breath, dry cough, tiredness and a loss of appetite.
PIPE-791 is an experimental new drug that is being tested in this research study. Researchers hope that the study drug will work by attaching itself (‘binding’) to sites in the lung. These sites are called lysophosphatidic acid receptor 1 (LPA1) and the new drug is thought to block the activity of these sites which are involved in the formation of lung scarring.
This study will look at the impact of the new drug, PIPE-791, on people with IPF and healthy people too. The aim of this study is to find out how much of the study drug gets into the lungs, what side effects there are, and the amount of the drug that gets into the blood system.
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?
During the 8 weeks before the study you’ll have a screening visit to see if you’re suitable to take part. Once you have passed screening you will return to London to be admitted onto a medical ward for up to 6 nights, the study will last up to 6 weeks, from your first admission to the ward until your last visit.
During that time, you will be asked to:
- Carry on taking your usual medicines
- Take a single dose of the study drug by mouth
- Give blood and urine samples
- Stay on the hospital research ward for up to 6 nights
- Attend up to 4 outpatient visits
- Have up to 3 PET scans (Positron Emission Tomography Scans), at least 2 of which may be done as outpatient visits
How long you stay on the ward will depend on the timings of your PET scans, but it won’t be longer than 7 days and 6 nights in a row.
You will have a final follow-up visit 14–16 days after taking the single dose of the study drug, or 2–4 days after your last PET scan, whichever is later.
Summary of involvement
Study duration up to 6 weeks
Take a single dose of the study drug, PIPE-791
Blood and urine samples
Stay on a hospital research ward in London for 1 to 6 nights
Up to 4 outpatient hospital visits in London
PET scans
Can I take part?
You may be able to take part if you have a diagnosis of IPF or you are a healthy participant, and are aged 25 to 65 years.
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 or are a healthy individual
You are aged 25 to 65
If you’re a woman, you must be unable to have a baby because: you’ve been through the menopause and your last period was at least 12 months ago; or you have had your womb, both your ovaries, or both your fallopian tubes removed
You have a body mass index (BMI) between 18.0 and 30.9 kg/m2
You are registered with a GP (family doctor) in the UK
You drink, on average, more than 14 units of alcohol weekly – 1 unit = ½ pint of beer, 1 small glass of wine or 1 measure of spirits
You use recreational drugs
You smoke cigarettes, vape, or use other tobacco or nicotine products (such as patches or gum) from 7 days before your screening visit until your final visit
You have donated blood or have taken part in a study of an experimental medicine in the last 3 months, or plan to do so in the 3 months after this study
You have had a serious reaction to any medicine
You have had an operation (such as a stomach bypass) or have any condition that could affect how your body absorbs or handles medicines
You have had a COVID-19 vaccine during the 7 days before your screening visit, or plan to have a COVID-19 vaccine during the study
You have or have had serious health conditions including: heart problems, mental health illness, epilepsy
You have certain types of implants or metal in your body, such as a pacemaker, aneurysm clip, shrapnel, stents or inner ear implants
There are other criteria which the research team will assess during your screening appointment.
What difference could taking part make?
If you take part, you will be helping with the wider context of medical research. This study will help researchers in understanding the impact of a new drug for people with IPF, to inform if it is potentially suitable to move on to the next phases of research, where it could be tested in a larger number of people. The researchers don’t expect you to get any individual medical benefit from taking part in the study, but it could help people affected by IPF in the future. It’s important for you to know that you cannot continue to take the study drug after the study has finished, even if you get some unexpected benefit from it.
You will recieve reimbursement for your time and expenses incurred as a result of taking part in the research study.
Where does the study take place?
Study locations
London
How to take part
If you are interested about taking part in research, please speak to your healthcare team about the various opportunities available to you. If you are interested in this trial, and would like more information, you can contact the recruitment team by phoning 0800 783 8792 or 020 8963 4502; or by emailing recruit@hmrlondon.com (please quote 24-502 in your e-mail).
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.
recruit@hmrlondon.comThis 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.
Action for Pulmonary Fibrosis 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