What next?
What next?
About this study
The study is randomised control trial which looks at the effects of a new drug called Zelasudil (RXC007), for people diagnosed with IPF.
Zelasudil targets a point in the lung cells that are involved in cell signalling, which plays a key role in both inflammation and changes in the lung structure that drives disease progression in many fibrotic conditions.
The aim of the study is to gain greater understanding about how the body responds to the drug and if it is suitable 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 involved in the study for up to 12 weeks. You will be randomly assigned into different groups. One group will be given the drug, Zelasudil, whereas the other group will be given a placebo. A placebo does not contain any active ingredients of the study drug and is a lookalike medication. If you are in the group that is given the drug, it will be given at different doses, depending on the timepoint at which you take part in the study.
When you take part in the study, the researchers will record your vital sign measurements at different timepoint, such as blood pressure, pulse rate, respiration rate and temperature; ECG recordings; and blood tests to gain understanding of how your body responds to the drug. Lung function tests will also be carried out.
After the study has finished, you will also be given an opportunity to take the drug for an additional 12 weeks, if you would like to. This option is available to both groups.
Summary of involvement
Up to 12 weeks
Taking a drug or placebo everyday
Medical assessments
Lung function tests
Can I take part?
You may be able to take part if you are aged between 40 and 80 years, and have a diagnosis of IPF within the last 5 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 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 between 40 and 80 years
Any gender
Diagnosis of IPF within the last 5 years
If taking nintedanib or pirfenidone, the participant must have been receiving treatment for at least 3 months, and on a stable dose for at least 4 weeks
There is a set lung function criteria to be able to take part in the study, which will be assessed by the research team
Currently or planning to receive treatment for IPF that is not approved for the disease
Lower respiratory tract infection requiring antibiotics within the last 4 weeks
Oxygen therapy for more than 15 hours per day
Acute exacerbation within the last 6 months
Diagnosis of connective tissue disease or interstitial pneumonia with autoimmune features
Other disease where life expectancy is less than 12 weeks
What difference could taking part make?
People affected by idiopathic pulmonary fibrosis IPF currently have limited treatment options to slow the progression of disease. New research studies, such as this one, are needed to gain valuable knowledge about potentially better treatment options.
Taking part in this study will help researchers to understand if Zelasudil could be an effective treatment for patients with IPF. The study will help to gain greater understanding of the medication, if it is safe and well tolerated, along with how the body responds to the drug.
Participation in research has the potential to make a difference for people who have PF now and for future generations.
Where does the study take place?
Study locations
Belfast
Birmingham
Cambridge
Edinburgh
Londonderry
London
Oxford
How to take part
If you would like to take part in this study or find out more information, please speak to your healthcare team to express your interest in research.
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.
This 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