What next?
What next?
About this study
The study aims to see how the body responds to a drug Garadacimab and the effect it has on 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 assigned at random to one of two groups. You will either receive the study drug, Garadacimab, or a lookalike drug which does not contain any active medication (placebo). Both the study drug and placebo are given as an injection and through a 'drip' (intravenous infusion) where a fluid is delivered into the body through a vein. You will have a number of different medical assessments, such as blood tests, and monitoring for up to 22 weeks.
Neither you or the researchers will know who has been given the active drug or the placebo until after the study has ended. This is to ensure truly understand the effect of the new drug.
Summary of involvement
Participation for up to 22 weeks
Single intravenous infusion and injection of either the study drug or a placebo
Monitoring of how the body responds to the drug through medical assessments
Can I take part?
You may be able to take part if you have a confirmed diagnosis of IPF, are 40 years and older, and have no clinically significant heart, blood pressure or bleeding disorders.
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.
Male or Female
Diagnosis of IPF
History of significant heart problems
History of uncontrolled high blood pressure
Problems with current bleeding or clotting disorders
What difference could taking part make?
Taking part in this study would help researchers to understand if the study drug is well tolerated and safe for people diagnosed with IPF.
Where does the study take place?
Study locations
Oxford
Birmingham
Londonderry
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@cslbehring.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