A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
This research study is looking into a new treatment called barzolvolimab for adults who have chronic spontaneous urticaria (CSU), more commonly known as chronic hives. These are hives that appear without a clear cause and have lasted for at least six months, even with regular antihistamine medication. The study wants to find out how well barzolvolimab works to control hives, whether it's safe to use, and how people tolerate it, compared to a placebo (a dummy treatment). Participants will receive either barzolvolimab or placebo for a period, followed by all participants receiving the active medicine. The study involves multiple visits and tracking your symptoms. It's a type of study that compares the new drug to standard care to see if it offers a better solution for managing chronic hives.
At a glance
What is this study about?
Imagine constantly dealing with itchy, red, and swollen patches on your skin, known as hives, that keep coming back without a clear reason. This condition is called Chronic Spontaneous Urticaria (CSU), and it can be very frustrating, affecting daily life. Even with commonly prescribed antihistamines, many people find their hives don't fully go away. This study is exploring a new potential treatment called barzolvolimab, which doctors hope might offer better relief for those struggling with CSU.
The main goal of this study is to understand if barzolvolimab is an effective and safe option for adults whose CSU isn't properly controlled by their current antihistamine medication. Researchers will compare how well the new medicine works against a 'placebo' – which looks like the active medicine but contains no active drug. This comparison helps doctors clearly see the effects of barzolvolimab itself. They will also keep a close eye on any side effects to make sure the medicine is well-tolerated.
This is a large-scale study involving many people across different locations, ensuring the results are reliable. It's designed to be 'double-blind,' which means neither you nor your study doctor will know whether you are receiving barzolvolimab or the placebo. This helps prevent any bias from influencing the results. By taking part, you could contribute to finding new and better ways to manage chronic hives, potentially improving the lives of many others in the future.
Key takeaways
- This study investigates a new treatment, barzolvolimab, for chronic spontaneous urticaria (CSU).
- It's for adults whose chronic hives are not well-controlled by antihistamines.
- The study compares barzolvolimab against a placebo (dummy treatment).
- Participation involves regular clinic visits and keeping a daily symptom diary.
- The total study duration is about 72 weeks.
- You will not know if you're receiving the active drug or placebo for the first 24 weeks.
Who may be eligible?
To be considered for this study, you need to be an adult (18 years or older) and have been diagnosed with chronic spontaneous urticaria (CSU) for at least six months. Your hives must still be active and bothering you, even if you're regularly taking non-drowsy antihistamines. Specifically, your hives need to have been present for at least six weeks, and you should be on a steady dose of antihistamines for at least four weeks before starting the study. Your study doctor will also check if your hive activity is at a certain level using special scores.
There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, you won't be able to take part. Also, if you have other skin conditions that cause itching, certain infections like HIV or hepatitis, or if you've had a severe allergic reaction (anaphylaxis) in the past, the study might not be suitable for you. You also cannot have received a live vaccine recently or plan to get one during the study.
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 had chronic hives for at least 6 months that still bother you even with antihistamines?
- Are you willing to use effective contraception if you or your partner could become pregnant?
- Are you able to attend regular clinic visits and record your daily symptoms?
- Are you NOT pregnant or breastfeeding?
What does participation involve?
If you decide to take part, the first step is a 'screening period' that could last up to four weeks. During this time, the study team will carry out health checks and tests to make sure you're a good fit for the study. After screening, you'll enter the main treatment part of the study, which lasts about 24 weeks. During this period, you will be randomly assigned to receive either barzolvolimab or a placebo (a dummy medicine).
Following that, all participants will receive barzolvolimab for about 28 weeks. After these treatment periods, there will be a 16-week 'treatment-free' period where you won't be taking the study medicine but will still be monitored. Throughout the study, you'll have regular visits to the clinic for health checks and to discuss your symptoms. You'll also be asked to keep a daily electronic diary to record your hive symptoms. The total duration of your participation, including all periods, will be around 72 weeks.
Potential risks and benefits
Locations (245)
- Allervie Clinical Research - CullmanVerified postcodeCullman, United States
- Research Solutions of Arizona PCVerified postcodeLitchfield Park, United States
- Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.Verified postcodeScottsdale, United States
- Center for Dermatology & Plastic SurgeryVerified postcodeScottsdale, United States
- Kern Research, Inc.Verified postcodeBakersfield, United States
- UCLA Clinical Trials Contracts & Strategic RelationsVerified postcodeLos Angeles, United States
- California Allergy and Asthma Medical GroupVerified postcodeLos Angeles, United States
- LA Universal Research Center, Inc.Verified postcodeLos Angeles, United States
- Allergy and Asthma Associates of Southern CalVerified postcodeMission Viejo, United States
- Huntington Asthma & Allergy CenterVerified postcodePasadena, United States
- Apex Clinical ResearchVerified postcodeSan Diego, United States
- WR-MCCRVerified postcodeSan Diego, United States
Common questions
What are 'chronic spontaneous urticaria'?
These are persistent hives that appear on your skin for at least six weeks, without a clear trigger, even with usual treatments like antihistamines.
What is barzolvolimab?
Barzolvolimab is a new medicine being tested to see if it can help control chronic hives better than existing treatments.
What does 'placebo' mean?
A placebo is a dummy treatment that looks like the real medicine but doesn't contain any active drug. It helps researchers compare the true effects of the new medicine.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know during the first part of the study. This is called 'double-blind' and helps make the study results fair.
How long will I be in the study?
If you are eligible and agree to participate, you will be in the study for a total of about 72 weeks, including screening, treatment, and follow-up periods.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.