What next?
What next?
About this study
The WHISTLE-PF clinical trial stands for Wound-Remodelling Hedgehog-Inhibitor ILD Study Testing Lung Function Endpoints. The WHISTLE-PF trial is looking at a new drug called ENV-101 for people with idiopathic pulmonary fibrosis (IPF). ENV-101 is thought to block a protein in the body in the body that might cause lung scarring (pulmonary fibrosis).
The aim of this trial is to understand more about the effects of ENC-101 on people with IPF and how it may impact their lung function.
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 WHISTLE-PF trial is right for you and you decide to take part, you will be asked to take the ENC-101 drug or a placebo once a day for six months. A placebo will look like the ENC-101, 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.
If you take part in the study, you will be able to continue your standard treatment if you are already taking antifibrotic medication (nintedanib or pirfenidone).
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 if you have a diagnosis of IPF and are aged 40 years and over.
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 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 been diagnosed with IPF
You are aged 40 years and over
Your breathing function meets the required levels
You have been receiving stable treatment of antifibrotics or immunosuppressants for at least three months
OR
You have not been treated with antifibrotics or immunosuppressants for at least eight weeks
You have had cancer within the last five years
You are currently smoking or have smoked within the last six months
You have had a serious illness that required being admitted to hospital within the last 90 days
You are pregnant or breastfeeding
You are sexually active and unwilling to use birth control for the duration of the study and three months after
You have taken ENV-101 before.
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.
Where does the study take place?
Study locations
Birmingham
Cambridge
Edinburgh
Exeter
Leicester
Londonderry
London
How to take part
If you would like more information about taking part in the study, please speak to your healthcare team.
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.
ebmclinical@endeavorbiomedicines.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