Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab

To join this study, you must be at least 12 years old. You need to have a clear diagnosis of hereditary angioedema (HAE), type 1 or type 2. This diagnosis should be confirmed by your doctor's records, including showing you have the right symptoms and specific blood test results that indicate HAE. Your medical history should also show that on-demand treatments (medicines taken during an attack) have worked for you in the past.

You should currently be taking a regular preventative medicine for your HAE, such as lanadelumab, berotralstat, or a plasma-derived C1-esterase inhibitor. You must have been on a steady dose of this medicine for at least three months before the study starts. This helps researchers see how the switch to garadacimab affects you, rather than changes in your old medicine.

There are also reasons why you might not be able to join. For example, if you have another type of angioedema alongside HAE, or if you're taking certain other medicines (like androgens or antifibrinolytics) to prevent HAE attacks. You also can't join if you're allergic to garadacimab.

If you decide to take part in this study, you will first go through a screening process to make sure you are suitable. Once confirmed, you will switch from your current HAE preventative medicine to the study medicine, garadacimab. You will receive garadacimab once a month for about three months. This will involve regular visits to the clinic where you will have health checks, blood tests, and doctors will ask about your HAE attacks and any side effects you might experience. The total duration of your participation in the study, from your initial checks to your final follow-up, will be clearly explained to you by the study team.