What next?
What next?
About this study
The clinical trial is designed to see if a new drug called HZN-825, can help people with IPF. The aim is to understand how the body responds to the new drug, and if it affects lung function.
People affected by IPF currently have limited treatment options to slow the progression of disease. New research studies such as this, are needed to gain valuable knowledge about better treatment options.
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 3 groups:
- Taking the new drug in the morning and a look alike medicine (placebo) in evening
- Taking the new drug in the morning and the evening
- Taking a look alike drug (placebo) in both the morning and evening
You would be asked to take part for up to 52 weeks, with the possibility of remaining in the study for another 52 weeks.
Tests will take place at different time points in the study. This may include lung function tests, six-minute walk test, questionnaires and other medical monitoring.
Patients, care providers and researchers will not know which group participants are in until the end of the initial 52-week study.
Summary of involvement
Taking a new drug or placebo tablets morning and evening
Lung function tests
Questionnaires
Other medical assessments
Can I take part?
You may be able to take part if you have a diagnosis of IPF and are aged 18 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.
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 18 years or above
Diagnosis of IPF
No recent or planned change to your IPF treatment
There is a criteria for lung function, but this must be discussed with the research team
Estimated minimum life expectancy of more than 30 months for non-IPF related disease
Significant cardiovascular disease
Interstitial lung disease (ILD) that is not IPF
Active infection
Use of prednisone, cyclosporine or rifampin
Malignant condition in the past 5 years
Those not agreeing to use birth control (where applicable)
Pregnant or breastfeeding women
Current drug or alcohol abuse or history within the previous 2 years
Positive test for human immunodeficiency virus (HIV), active hepatitis
Current alcoholic liver disease, primary biliary cirrhosis or primary sclerosing cholangitis
Previous organ transplant
Recent exposure to an experimental drug or experimental vaccine
What difference could taking part make?
Taking part in this clinical trial will help researchers to understand the potential effects of the new drug. The study will help to see if it has the potential to help people with IPF.
Where does the study take place?
Study locations
Liverpool
How to take part
Please discuss this with your healthcare team and Consultant in the first instance, to express your interest in the study and hearing about opportunities to take part in research.
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.
clinicaltrials@horizontherapeutics.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