Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
This study is an extension of previous research, focusing on the long-term safety and effectiveness of a medication called barzolvolimab for adults living with Chronic Spontaneous Urticaria (CSU), also known as chronic hives. Participants in this study have already completed the main treatment and follow-up parts of earlier Phase 3 trials. The main goals are to gather more information on how the drug works over time, how safe it is, and to provide continued access to barzolvolimab for those who might benefit from it after their initial study finished. Researchers want to understand how long the drug can prevent hives from worsening or if treatment needs to be adjusted.
At a glance
What is this study about?
This study is designed for adults who have chronic spontaneous urticaria (CSU), a condition that causes itchy hives and swelling without an obvious trigger. This can be a very challenging condition to live with, and treatments aim to reduce symptoms and improve quality of life. You might know this condition as chronic hives.
Researchers are looking at a drug called barzolvolimab. This study is an important next step for people who have already taken part in earlier studies of barzolvolimab. The main idea is to see how well the drug works and how safe it is over a longer period of time. This information helps doctors understand if the drug is a good long-term option for managing CSU. It also helps fulfill a promise from the drug company to continue providing access to the treatment for those who have completed the initial studies.
By carefully watching how people respond over time, doctors can learn more about how to best use barzolvolimab for CSU. They also want to understand if there are certain signs that someone's condition might worsen, and if starting the treatment again can help. Your participation helps researchers gather vital information that could benefit many other people with chronic hives in the future.
Key takeaways
- This study is for adults with chronic hives (CSU) who finished earlier barzolvolimab studies.
- It aims to understand the long-term safety and effectiveness of barzolvolimab.
- Participation lasts roughly 52 to 68 weeks, depending on your group and treatment needs.
- You'll have regular clinic visits and keep a daily symptom diary.
- The study offers continued treatment access for qualifying participants.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you must be an adult aged 18 or older and have already successfully completed one of the previous main barzolvolimab studies (specifically, CDX0159-12 or CDX0159-13). This is crucial because this study is a continuation of that earlier research.
You'll also need to be willing to give your written consent to take part and follow all the study's instructions, including filling out a daily diary about your symptoms. If you are a woman who could become pregnant, or a man whose partner could become pregnant, you'll need to agree to use effective birth control during the study and for about five months after your last treatment.
There are also some reasons why you might not be able to join. For example, if you have another itchy skin condition that isn't CSU, or if you have any other serious medical conditions that might make taking part risky or interfere with the study. Your study doctor will go through all the specific criteria with you to make sure this study is right for you.
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?
- Have you successfully completed one of the previous barzolvolimab Phase 3 studies (CDX0159-12 or CDX0159-13)?
- Are you willing to use effective birth control if you or your partner could become pregnant?
- Can you attend regular clinic visits and complete a daily electronic diary?
- Do you have any other itchy skin conditions or serious medical problems that might interfere with the study?
What does participation involve?
If you join this study, your involvement will typically last between approximately 52 to 68 weeks. The exact length depends on your group and how your condition changes.
There are two main groups in the study. If your hives are currently well-controlled (meaning your UAS7 score is less than 16), you might be in the 'observation group'. You won't receive barzolvolimab unless your hives get worse. If your hives get worse in this group and you need to restart treatment, your time in the study could extend to about 68 weeks. If your hives are still quite active (UAS7 score of 16 or higher), you'll likely be in the 'retreatment group' and will receive barzolvolimab again, with your participation lasting about 68 weeks from when your treatment starts.
Throughout the study, you'll have regular visits to the clinic, and you'll need to keep a daily electronic diary to record your symptoms. This helps the study team track how you're feeling and how the treatment is working. You will receive the study medication (barzolvolimab) as needed, depending on your group and how your condition progresses.
Potential risks and benefits
Locations (34)
- Cahaba Dermatology & Skin Health Center, LLCVerified postcodeBirmingham, United States
- Center for Dermatology & Plastic Surgery - AvacareVerified postcodeScottsdale, United States
- Dermatology Research AssociatesVerified postcodeLos Angeles, United States
- LA Universal Research Center, Inc.Verified postcodeLos Angeles, United States
- Encore Medical Research of Boynton Beach LLCVerified postcodeBoynton Beach, United States
- Direct Helpers Research CenterVerified postcodeHialeah, United States
- Deluxe Health CenterVerified postcodeMiami Lakes, United States
- Sarasota Clinical ResearchVerified postcodeSarasota, United States
- Advanced Clinical Research Institute (ACRI) - FloridaVerified postcodeTampa, United States
- Centricity Research Columbus DermatologyVerified postcodeColumbus, United States
- Endeavor HealthVerified postcodeSkokie, United States
- The South Bend Clinic - AvacareVerified postcodeSouth Bend, United States
Common questions
What is barzolvolimab?
Barzolvolimab is a study drug being investigated as a treatment for chronic spontaneous urticaria (chronic hives).
What are 'chronic spontaneous urticaria' (CSU)?
CSU refers to chronic hives and swelling that appear without a clear cause, lasting for at least six weeks.
Why is this study important for people who have already completed the previous studies?
It helps researchers understand the long-term effects and safety of barzolvolimab and can offer continued access to the treatment for participants.
How long will I be in the study if I participate?
Depending on your group and if you need treatment, your participation will last for approximately 52 to 68 weeks.
Can I leave the study at any time?
Yes, you are free to leave the study at any time, for any reason, and this will not affect your regular 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?
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