A randomized, placebo-controlled, parallel-group, investigator- and participant-blinded Phase 2a study to investigate the efficacy, safety, and tolerability of DFV890 and MAS825 for inflammatory marker reduction in an adult population with coronary heart disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP)
This research study is looking into two new experimental medicines, DFV890 and MAS825. It’s for adults who have coronary heart disease (a condition affecting the heart's blood supply) and a specific blood condition called Clonal Hematopoiesis of Indeterminate Potential (CHIP). CHIP means there are changes in some blood cells, which can sometimes be linked to inflammation. We want to find out if these new medicines can help reduce inflammation in the body, which might be good for heart health. We’ll also carefully check how safe the medicines are and if people taking them experience any side effects. Some participants will receive one of the study medicines, while others will get a placebo (a dummy treatment with no active drug) to compare the results fairly.
At a glance
What is this study about?
This study is focused on a common heart condition called coronary heart disease, where the blood vessels supplying the heart become narrowed or blocked. We are also looking at people who have a particular blood condition known as Clonal Hematopoiesis of Indeterminate Potential, or CHIP for short. CHIP means that some of your blood cells have developed certain changes as you've gotten older. While CHIP doesn't always cause problems, it can sometimes be linked to higher levels of inflammation in the body. We believe that reducing inflammation could potentially help people with heart disease.
The main goal of this study is to test two new experimental medicines, DFV890 and MAS825. These medicines are designed to reduce specific inflammation markers in the blood. We will be giving these medicines, or a placebo (a dummy treatment), to adult participants over a period of time. We want to see if these medicines can effectively lower certain inflammatory chemicals in the blood after a few weeks.
Another very important part of this study is to carefully check the safety of DFV890 and MAS825. We will be looking for any side effects and monitoring participants' overall health very closely. We also want to understand how the body processes these new medicines to make sure we are giving the right amount. By the end of this study, we hope to learn if these experimental treatments could be a safe and effective way to help people with heart disease and CHIP by tackling inflammation.
Key takeaways
- This study is for adults with coronary heart disease and a blood condition called CHIP.
- It's testing two new experimental medicines, DFV890 and MAS825, against a placebo.
- The main aim is to see if these medicines can lower inflammation in the body.
- Safety and side effects will be carefully monitored throughout the study.
- Participation involves regular clinic visits for health checks and tests.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit for taking part.
Importantly, you must have been diagnosed with coronary heart disease. You also need to have the blood condition called Clonal Hematopoiesis of Indeterminate Potential (CHIP). The study team will check your medical records to confirm these diagnoses.
There will be other health checks and tests as part of the screening process to make sure the study is a good fit for you and that it would be safe for you to take part. For example, some existing health conditions or medicines might mean you are not suitable for this study.
- Are you 18 years old or older?
- Have you been diagnosed with coronary heart disease?
- Have you been told you have a blood condition called CHIP?
- Are you able to attend regular clinic appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you will be part of it for several months. You'll have regular visits to the clinic, where the study team will carry out health checks.
You will receive either one of the new experimental medicines (DFV890, which is a tablet, or MAS825, which is an injection) or a placebo (a dummy tablet or injection that looks the same but contains no active medicine). You won't know whether you are getting the active medicine or the placebo, and neither will your study doctor – this is to make sure the results are fair.
During your visits, you'll have blood tests, urine tests, and an ECG (a simple test to check your heart's electrical activity). We will also check your vital signs like blood pressure and heart rate. You’ll be asked about how you are feeling and if you have noticed any side effects. The total duration of your participation, including follow-up after stopping the study medicine, will be explained to you by the study team.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is coronary heart disease?
It's a condition where the main blood vessels that supply the heart become clogged or narrowed, which can lead to problems like angina or heart attacks.
What is CHIP?
CHIP stands for Clonal Hematopoiesis of Indeterminate Potential. It means some of your blood cells have developed certain changes as you’ve gotten older, and it’s sometimes linked to inflammation.
What is a placebo?
A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps us compare the real medicine's effects fairly.
Will I know if I'm getting the real medicine?
No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This is called 'blinding' and helps ensure unbiased results.
Do I have to pay to join the study?
No, all study-related treatments and assessments are usually provided free of charge if you qualify and choose to participate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.