What next?
What next?
About this study
This study is finding out how a new drug, CHF10067, might affect people with IPF. The drug is a monoclonal antibody (MAB), which recognises and finds proteins on specific cells and help the immune system. Some patients who take part will be given the study drug and some will not.
The researchers want to learn how the new drug affects the body when it is given to people with IPF.
The study will learn about any side effects of the drug and understand how people respond to it.
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 given either a single dose of a new drug, CHF10067, or a lookalike drug (placebo). The placebo does not contain the active medicine and instead will just contains fluids. Patients who are given the new drug will be receive a low, medium or higher dose. The drug or the placebo will be given to you through an intravenous drip. This will happen just once during the study. People who take part will be monitored before receiving the treatment, through to the end of the study at day 84.
Summary of involvement
Participation for up to 84 days
Single intravenous dose of either the new drug or a placebo
Monitoring of how the body responds to the drug through medical assessments and blood tests
Lung function tests & heart monitoring
Can I take part?
You may be able to take part if you have a confirmed diagnosis of IPF and are aged between 40 and 80 years.
You can be taking antifibrotic medication (nintedanib or pirfenidone) if your treatment has been stable for 8 weeks. You can also take part if you are not taking antifibrotics.
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 between 40 and 80 years
Body weight greater than 45 kg
Diagnosis of IPF within the past 5 years
Either:
Not receiving antifibrotic treatment
OR
Stable and well tolerated antifibrotic treatment
There is also a criteria for lung function, but this must be discussed with the research team
Respiratory infection within the last 2 months
An acute exacerbation within the last 3 months
Current diagnosis of lung cancer or any other form of cancer within the last 5 years
Current wound healing or foot ulcer complications
Current heart failure or severe pulmonary hypertension
Pregnant or breastfeeding women
Currently taking or have taken, corticosteroids, immunosuppressants, cytotoxic therapy, or vasodilator therapy for pulmonary hypertension within the last 4 weeks
Received investigational or unapproved treatment for IPF within the last 4 weeks
What difference could taking part make?
People affected by IPF currently have limited treatment options to slow the progression of disease. New research, such as this study, is needed to gain valuable knowledge about potentially better treatment options.
Taking part in this study would help researchers to understand the effects of the new drug when given to people with IPF. The study will help to gain understanding of which drug dose may be most suitable for future investigations in further research studies.
Where does the study take place?
Study locations
Birmingham
Cambridge
Dundee
Edinburgh
Liverpool
Manchester
How to take part
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_info@chiesi.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