A Long-Term Study of Navenibart in Participants With Hereditary Angioedema
This study is for people aged 12 and older who have a condition called hereditary angioedema (HAE). It's a long-term study looking at a medicine called navenibart. This medicine aims to help manage HAE. Only people who have already taken part in a specific previous study (called STAR-0215-301) can join this one. The study has two parts. In the first part, everyone gets a set dose of navenibart. In the second part, the dose might be adjusted to best suit each person's needs. The main goal is to understand how well navenibart works and if it's safe over a longer period.
At a glance
What is this study about?
You might be reading this because you, or someone you know, has a condition called hereditary angioedema, or HAE. HAE causes sudden and often painful swelling attacks. This study is looking at a new medicine called navenibart that aims to help people manage their HAE attacks more effectively.
This is a long-term study, which means it will follow people over an extended period. Doctors want to understand how safe and effective navenibart is when taken for a longer time. They also want to see if adjusting the dose to fit each person's individual needs makes a difference in how well the medicine works and if it’s more comfortable to use.
This study is for people who have already been part of a previous study testing navenibart (called STAR-0215-301). It’s designed to continue gathering important information about this potential new treatment for HAE. The information collected will help doctors and researchers understand if navenibart could be a good long-term option for people with HAE.
Key takeaways
- This study is for people with Hereditary Angioedema (HAE) aged 12 and older.
- It's a long-term study to check the safety and effectiveness of a medicine called navenibart.
- Only people who previously participated in the STAR-0215-301 study can join.
- The study has two parts: a fixed dose and then a personalised dose option.
- You can leave the study at any time without affecting your medical care.
Who may be eligible?
To be able to join this study, you must have been part of an earlier study called STAR-0215-301. It’s important that you either finished that study right up to day 181, or if you left early, you still received at least two doses of the study medicine and had at least two months of follow-up after the second dose. The study doctors will also check if you meet all other necessary requirements.
There are also some reasons why you might not be able to join. For example, if you've recently taken part in another medical study (other than STAR-0215-301) or used an experimental drug within the last 30 days. You also can't join if you've taken certain blood pressure medicines (called ACE inhibitors) or medicines containing estrogen (like some contraceptive pills or hormone replacement therapy) within 30 days before starting this study.
Finally, if you know you are sensitive or allergic to any of the ingredients in the navenibart medicine, you won't be able to take part.
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.
- Have I previously taken part in the STAR-0215-301 study for HAE?
- Did I finish the STAR-0215-301 study or receive at least 2 doses of the study medicine if I left early?
- Have I avoided other experimental medicines or studies (other than STAR-0215-301) in the last 30 days?
- Have I avoided certain blood pressure medicines (ACE inhibitors) or estrogen-containing medicines in the last 30 days?
- Am I aware of being allergic or sensitive to any ingredients in the study medicine?
What does participation involve?
The study is for people aged 12 and older. It's a long-term study, and will involve regular visits to the clinic for assessments. These visits will help the study team monitor your health, how well the medicine is working, and if you have any side effects. You will receive the study medicine, navenibart. In the first part of the study, everyone will take a set dose. In the second part, your doctor might adjust the dose to best suit your personal needs. We can't give an exact total duration here, but it's designed to be a long-term follow-up to the previous study.
Potential risks and benefits
Locations (28)
- Site 2Verified postcodeScottsdale, United States
- Site 3Verified postcodeLittle Rock, United States
- Site 7Verified postcodeSan Diego, United States
- Site 4Verified postcodeSanta Monica, United States
- Site 1Verified postcodeWalnut Creek, United States
- Site 5Verified postcodeCentennial, United States
- Site 19Verified postcodeColorado Springs, United States
- Site 21Verified postcodeWheaton, United States
- Site 6Verified postcodeCincinnati, United States
- Site 9Verified postcodeHershey, United States
- Site 22Verified postcodeSanto André, Brazil
- Site 20Verified postcodeSofia, Bulgaria
Common questions
What is hereditary angioedema (HAE)?
HAE is a rare genetic condition that causes unexpected and sudden swelling in various parts of the body, such as the face, hands, feet, belly, or throat.
What is navenibart?
Navenibart is the name of the medicine being tested in this study, which aims to help prevent or reduce HAE attacks.
Why is this study only for people who were in a previous study?
This study is a follow-up to an earlier study (STAR-0215-301). It’s designed to continue collecting information on the long-term safety and effectiveness of navenibart in people who have already started the treatment.
Will I get paid for taking part?
The study information does not mention payment, but you should ask the study team if there is any reimbursement for travel expenses or time.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, for any reason, without needing to explain why, and it will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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