Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)
This study, called ADX-324-302, is for people who have already completed a previous trial for a condition called hereditary angioedema (HAE). HAE is a rare genetic disorder that causes episodes of severe swelling. This new study is an 'extension study,' meaning it follows on from the earlier trial. Its main purpose is to gather more information about how safe the medicine, ADX-324, is over a longer period and how well it helps control swelling attacks in people with Type 1 and Type 2 HAE. Researchers will also look at how the body handles the medicine and how it affects people's quality of life. This study is for adults aged 18 and over who have HAE.
At a glance
What is this study about?
This study is a follow-up for people who have taken part in a previous clinical trial for hereditary angioedema (HAE). HAE is a conditions where people experience sudden, severe swelling in different parts of their body, which can be painful and sometimes life-threatening. The medicine being studied is called ADX-324.
The main goal of this particular study is to learn more about the long-term effects of ADX-324. While the previous study looked at its initial safety and effectiveness, this extension study will help doctors understand how well the medicine works over a longer time and if it continues to be safe for people with Type 1 and Type 2 HAE.
Researchers will also be checking how the body processes the medication and if it helps improve the daily lives of people living with HAE. This study is an important step in making sure new medicines are both safe and helpful for patients.
Key takeaways
- This is an extension study for people with HAE who finished a previous trial.
- It aims to learn more about the long-term safety and effectiveness of ADX-324 for HAE.
- Participation involves continued medication and regular health check-ups.
- The study includes adult participants (18 years and older) with Type 1 or Type 2 HAE.
- Your well-being and access to acute HAE treatment are important throughout the study.
Who may be eligible?
To join this study, you must have a confirmed diagnosis of hereditary angioedema (HAE), either Type 1 or Type 2. You would also need to have completed the previous study called ADX-324-301. It's also important that you have access to treatments for HAE attacks, such as certain medications that stop the swelling.
There are a few reasons why someone might not be able to join. For example, if you had a bad reaction to the study medicine (ADX-324) in the previous ADX-324-301 study, you wouldn't be able to participate in this extension. The study is open to adults aged 18 and older, both men and women.
- Do you have a confirmed diagnosis of hereditary angioedema (HAE) Type 1 or Type 2?
- Have you already completed the previous ADX-324-301 study?
- Are you 18 years of age or older?
- Do you have access to treatments for HAE attacks, if needed?
- Did you have a negative reaction to the study drug in the previous ADX-324-301 study? (If yes, you might not be eligible).
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would continue to receive doses of the study medicine, ADX-324. The study team would closely monitor your health and how you respond to the medicine. This will involve regular visits to the study clinic for assessments, which might include blood tests, physical examinations, and questionnaires about your health and how you are feeling. The exact number and frequency of visits, as well as the total duration you would be involved, would be explained in detail by the study team, as this is an extension study and builds upon previous participation.
Potential risks and benefits
Locations (48)
- ADARx Clinical SiteLitchfield Park, United States· Not yet recruiting
- ADARx Clinical SiteLittle Rock, United States· Not yet recruiting
- ADARx Clinical SiteSan Diego, United States· Not yet recruiting
- ADARx Clinical SiteWalnut Creek, United States· Not yet recruiting
- ADARx Clinical SiteOrlando, United States· Not yet recruiting
- ADARx Clinical SiteChevy Chase, United States· Not yet recruiting
- ADARx Clinical SiteWheaton, United States· Not yet recruiting
- ADARx Clinical SiteDetroit, United States· Not yet recruiting
- ADARx Clinical SiteSt Louis, United States· Not yet recruiting
- ADARx Clinical SiteLas Vegas, United States· Recruiting
- ADARx Clinical SiteNew York, United States· Not yet recruiting
- ADARx Clinical SiteCincinnati, United States· Not yet recruiting
+36 more sites — see the official record for the full list.
Common questions
What is an 'extension study'?
An extension study is a follow-up study for people who have already taken part in an earlier trial. It helps researchers gather more information about a medicine over a longer period.
What is hereditary angioedema (HAE)?
HAE is a rare genetic condition that causes sudden and repeated episodes of severe swelling in different parts of the body.
What is ADX-324?
ADX-324 is the specific medicine being studied in this trial for its potential to treat hereditary angioedema.
Will I receive treatment for my HAE attacks during the study?
Yes, if you join this study, you must still have access to your usual and approved treatments to manage any HAE attacks you might experience.
Who can participate in this study?
This study is for adults aged 18 and over who have a confirmed diagnosis of Type 1 or Type 2 HAE and have already completed the previous ADX-324-301 study.
How to find out more
Lupe Gallegos
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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