Open-label safety study in adults and adolescents with haemophilia A with and without FVIII inhibitors switching directly from emicizumab prophylaxis to NNC0365-3769 (Mim8) prophylaxis.
This study is for adults and teenagers with haemophilia A, whether they have certain antibodies (inhibitors) or not. It's looking at a new medicine called denecimig. The main goal is to see how safe denecimig is when people switch directly from their current haemophilia medicine, emicizumab. Doctors will be carefully checking for any new health problems that might pop up during the study. They also want to understand how easy it is to use the device that gives the medicine and how taking part in the study might affect a person's life and treatment routine. This is a later-stage study, meaning the medicine has already been tested in earlier stages.
At a glance
What is this study about?
Imagine you have haemophilia A. This is a condition where your blood doesn’t clot properly, which can lead to bleeding problems. There are treatments available, and some people might be taking a medicine called emicizumab to help prevent bleeding. This study is testing a new medicine, called denecimig, to see if it's a good and safe option for people with haemophilia A.
The main thing doctors want to find out is how safe denecimig is for people who switch straight from emicizumab. They will be keeping a close eye on any new health issues or side effects that might happen. They're also interested in how easy the medicine delivery device is to use and how participating in the study affects people's daily lives and their overall experience with treatment.
This is a 'Phase III' study. This usually means the medicine has already gone through earlier tests and shown some promise. Now, researchers need to confirm its safety and how well it works in a larger group of people before it can be made available more widely.
Key takeaways
- This study is for people with haemophilia A.
- It's testing a new medicine called denecimig.
- The main focus is on the safety of switching from emicizumab to denecimig.
- It also looks at how easy the medicine is to use and its impact on your life.
- It's a Phase III study, meaning it's a later stage of research.
Who may be eligible?
This study is looking for adults aged 18 and over who have haemophilia A. It doesn't matter if you are male or female, anyone can take part.
It's important to note that you don't need to have specific 'inhibitors' (certain antibodies that can make treatment harder) for haemophilia A to be considered for this study; people with or without these inhibitors might be able to join.
The most important thing for eligibility related to treatment is if you are currently taking a medicine called emicizumab to help manage your haemophilia. This study is specifically for people switching from that particular medication.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have haemophilia A?
- Are you currently taking emicizumab for your haemophilia?
- Are you comfortable with potentially switching to a new medication?
- Are you able to attend study visits regularly?
What does participation involve?
If you join this study, you would switch from your current emicizumab medicine to the new denecimig medicine. You would likely have regular visits to a clinic for health checks, blood tests, and to discuss any side effects you might be experiencing. You would also be asked to fill out questionnaires about how easy the medicine delivery device is to use and how the treatment affects your life. The specific length of the study isn't detailed, but Phase III studies often last for a number of months, or even longer, depending on what researchers need to learn about the new medicine.
Potential risks and benefits
Locations (6)
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedAustria
- —UnverifiedItaly
- —UnverifiedGermany
Common questions
What is haemophilia A?
Haemophilia A is a condition where your blood doesn't clot properly, leading to longer bleeding after injuries.
What does 'inhibitors' mean in haemophilia?
Inhibitors are like antibodies your body can make that stop certain haemophilia medicines from working as well as they should.
What is a 'Phase III' study?
A Phase III study is a later-stage clinical trial looking to confirm the safety and effectiveness of a new medicine in a larger group of people.
Will I have to pay to be part of the study?
No, typically clinical trial medicines and study-related care are provided free of charge, but you should always confirm this with the study team.
Can I stop taking part if I change my mind?
Yes, you can choose to leave the study at any time, and you don't have to give a reason why. Your regular medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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