Astria STAR-0215-302 trial for Navenibart in Hereditary Angioedema
Researchers are studying a new medicine called navenibart for hereditary angioedema (HAE), a condition causing unpredictable swelling attacks. These attacks can be very painful and disabling. Navenibart is designed to help prevent these attacks. This study, called ORBIT-EXPANSE, is particularly interested in checking the safety and how well people cope with navenibart over a long period, up to five years. It's for adults and teenagers (aged 12 and older) who have already taken part in a previous navenibart trial (ALPHA-ORBIT). The information gathered will help improve future treatments for HAE, even if there's no direct benefit for every individual participant.
At a glance
What is this study about?
Hereditary angioedema (HAE) is a rare condition that causes sudden and painful swelling. These swelling attacks can affect different parts of the body, like the face, arms, legs, and even the throat, which can be very serious. Currently, people with HAE take medicines to stop attacks once they start, or to prevent them from happening. However, sometimes these treatments need to be taken very often, which can be difficult for patients.
This study is looking at a new medicine called navenibart. Navenibart is a type of medicine that works with your body's immune system. It aims to prevent HAE attacks by blocking a specific natural process in the body that causes the swelling. Early studies have suggested that navenibart could be helpful in preventing these attacks. The company that makes navenibart, Astria Therapeutics, wants to learn more about how it works in people with HAE.
The main goal of this study, called ORBIT-EXPANSE, is to understand how safe navenibart is and how well people tolerate it when taken over a long time. This includes both adults (18 and older) and teenagers (12-17 years old). Participants will be in the study for up to five years. The information gathered from this research will help doctors and scientists better understand HAE and develop more effective and convenient treatments in the future.
Key takeaways
- New medicine (navenibart) for hereditary angioedema (HAE) is being studied.
- Aims to check long-term safety and how well people tolerate the medicine.
- For adults and teenagers (12+) who completed a previous navenibart study (ALPHA-ORBIT).
- Participants will receive navenibart through under-the-skin injections.
- Study could last up to five years.
- Results will help improve future HAE treatments.
Who may be eligible?
This study is for people who have hereditary angioedema (HAE) and have already taken part in a previous study for navenibart called ALPHA-ORBIT (STAR-0215-301). You would have either completed the ALPHA-ORBIT study or left it early but still received at least two doses of the study medicine and had at least two months of follow-up after the second dose.
You cannot take part if you have been in another medical study (apart from ALPHA-ORBIT) in the last 30 days, or if you've had certain study medicines (other than navenibart) recently. Also, if you've taken certain blood pressure medicines (called ACE inhibitors) or hormone-containing medicines (like some contraceptives or hormone replacement therapy) in the last 30 days, you won't be able to join.
Finally, if you know you are allergic to any of the ingredients in navenibart, this study would not be suitable for you. The study is open to both men and women, aged 12 years and older.
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.
- I have hereditary angioedema (HAE).
- I previously took part in the ALPHA-ORBIT study (STAR-0215-301).
- I completed the ALPHA-ORBIT study or met specific criteria if I left it early.
- I have not taken part in another recent medical study (apart from ALPHA-ORBIT).
- I have not recently used certain blood pressure or hormone medicines.
- I am not allergic to any ingredients in navenibart.
What does participation involve?
If you join this study, your involvement could last for up to five years. All participants will receive the study medicine, navenibart, which is given as an injection just under the skin.
For adults who were in the ALPHA-ORBIT study, the first part of this new study will last at least six months. If you received navenibart in ALPHA-ORBIT, you'll continue with the same dose. If you received a placebo (a dummy treatment) in ALPHA-ORBIT, you'll start receiving 600mg of navenibart every three months. After this first part, adults may be able to discuss changing their dose with the study doctors. Teenagers in the study will continue to receive navenibart at the same dose they had in the ALPHA-ORBIT study.
Potential risks and benefits
Locations (6)
- Frimley Health NHS Foundation TrustCity onlyCamberley, England
- Barts Health NHS TrustCity onlyLondon, England
- North Bristol NHS TrustCity onlyBristol, England
- Royal Free London NHS Foundation TrustCity onlyLondon, England
- University Hospitals Plymouth NHS TrustCity onlyPlymouth, England
- Cambridge University Hospitals NHS Foundation TrustUnverifiedCambridge, England
Common questions
What is hereditary angioedema (HAE)?
HAE is a rare genetic condition that causes sudden, unpredictable, and often painful attacks of swelling in different parts of the body.
What does navenibart do?
Navenibart is a new medicine being studied to help prevent HAE attacks by blocking a natural process in the body that leads to swelling.
How is navenibart given?
Navenibart is given as an injection just under the skin, using a small needle.
How long will I be in the study?
If you join, your participation could last for up to five years.
Will I definitely receive the study medicine?
Yes, all participants in this study will receive navenibart.
How to find out more
. Clinical Trial Inquiries
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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