Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A phase 4 open-label study to evaluate the safety after switching to CSL312 (Garadacimab) from current prophylactic HAE treatment in subjects with HAE ≥ 12 years of age

This research is a follow-up study for people aged 12 and older who have a health condition called Hereditary Angioedema, often shortened to HAE. HAE causes sudden, unpredictable swelling attacks. The study investigates a medication known as garadacimab. Participants will switch from their current HAE prevention treatment to garadacimab. The main goal is to carefully check for any new or worsening side effects that might happen after this switch. Researchers will count how many people experience side effects, how often they occur, and how severe they are. This information helps doctors understand the long-term safety of garadacimab when used in a real-world setting.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

CSL Behring LLC

Enrolment target

Start

15 Aug 2025

Hereditary Angioedema (HAE)

What is this study about?

This study is looking into a medicine called garadacimab for people who have Hereditary Angioedema, or HAE. HAE is a rare condition that causes unexpected and often painful swelling attacks in various parts of the body, like the hands, feet, face, or airways. These attacks can be quite frightening and disruptive to daily life. Many people with HAE take medication regularly to try and prevent these attacks from happening, which is called prophylactic treatment.

This particular study is designed to see how safe garadacimab is when people switch to it from their previous preventative HAE medication. It's an "open-label" study, which means both the patients and their doctors will know they are receiving garadacimab. This is a "Phase 4" study, meaning the medicine is already approved for use, and researchers are gathering more information about its effects, especially its safety, when used by a wider group of people in typical medical settings.

The main aim of the study is to keep a close eye on any side effects that people experience after starting garadacimab. The researchers will count how many people have side effects, how many side effects happen in total, and whether these side effects lead to someone stopping the study. They will also look at how severe any side effects are. By collecting this detailed safety information, doctors can get a better understanding of garadacimab's profile and help patients make informed choices about their treatment.

Key takeaways

The study is for people aged 18 and over with Hereditary Angioedema (HAE).
It evaluates the safety of switching to a new medication called garadacimab.
Researchers will closely monitor for any side effects after the switch.
It's a Phase 4 study, gathering more safety data for an already approved drug.
Your health will be regularly checked throughout your participation.

Who may be eligible?

To join this study, everyone must be at least 18 years old. Both men and women can take part.

You would also need to have Hereditary Angioedema (HAE) and already be taking a regular preventative medication for your HAE. The study involves switching from your current HAE prevention treatment to garadacimab.

The research team will have a more detailed list of criteria to make sure the study is right for you and that taking part would be safe. They will discuss all of these points with you thoroughly.

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 a diagnosis of Hereditary Angioedema (HAE)?
Are you currently taking a regular medication to prevent HAE attacks?
Are you open to switching to a new HAE prevention medication (garadacimab)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would switch from your current regular HAE medication to garadacimab. You would have regular appointments with the study team. During these appointments, doctors and nurses would check your health, ask about any side effects you might be having, and take blood samples. These checks are important to see how your body is responding to the new medication and to monitor your overall health and safety.

The study will also involve keeping track of any HAE attacks you might have and how you feel in general. You might also be asked about your preference for garadacimab compared to your previous treatment. The total duration of the study will be explained in detail by the research team, including how many visits you would need and how long each visit might be.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as trying a new medication for your HAE that may be effective for you. However, as with any medication, there are potential risks, including side effects from garadacimab. The research team will explain all known and potential side effects in detail. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is Hereditary Angioedema (HAE)?

HAE is a rare genetic condition that causes sudden and painful swelling attacks in different parts of the body, like the skin or airways.

What is garadacimab?

Garadacimab is a medication for treating Hereditary Angioedema (HAE). This study investigates its safety when people switch to it from another treatment.

What does 'open-label' mean?

Open-label means that everyone involved – including the patients and their doctors – knows which medication the patient is receiving in the study.

Why is this study being done?

This study aims to collect more information about the long-term safety of garadacimab, especially focusing on side effects after people switch from their usual HAE prevention medication.

Can I stop participating in the study if I want to?

Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, without your medical care being affected.