Chronic Spontaneous Urticaria (Persistent Hives) Study for Adults
Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about whether the study drug benralizumab works, and to see how safe it is for people with chronic spontaneous urticaria (CSU), which is a form of persistent hives. Benralizumab, in this study, is considered experimental since it is not approved by any health authority for patients with CSU. It is, however, approved for use in patients with severe eosinophilic asthma.
Who can participate?
Adults who have been diagnosed with CSU who experience itching and wheals (hives) for at least 6 weeks despite taking an antihistamine may be eligible to participate.
- Adult Studies
What will happen in the study?
This study includes at least 16 visits over approximately 60 weeks (one visit approximately every 4 weeks). During the first 24 weeks of the study, you have a 75% chance of receiving the study drug, benralizumab, and a 25% chance of receiving a placebo.
During the following 28 weeks of the study, all participants will receive active study drug. During the first two weeks, you will receive 2 injections at study visits and after the first 12 weeks you will receive 1 injection per study visit. After each injection, you will be required to stay at Cincinnati Children’s for at least 1 hour to ensure you do not have any reactions.
During your time in the study, we will complete the following:
- Ask about your medical history and your current and past medications and treatments
- Collect your vital signs
- Perform a physical examination
- Perform an electrocardiogram to see how your heart works
- Collect blood samples
- Perform a skin biopsy
- Administer the study drug via an injection
- Ask you to complete questionnaires
What are the good things that can happen from this research?
It is possible that participants may see improvement in symptoms when taking the study drug. The information obtained during this study may help better treat patients with CSU in the future.
What are the bad things that can happen from this research?
Participants may have side effects while in this study. With any drug, unusual, unexpected or previously not reported reactions and side effects may occur. Possible side effects that may occur that have been seen in 3% or more patients include headaches, sinus infection, common cold, worsening asthma, bronchitis, the flu, increased blood pressure, upper respiratory tract infection, and nasal congestion. We will discuss possible risks and discomforts in further detail with those interested in learning more about the study.
Will you/your child be paid to be in this research study?
You will receive up to $1,150 for completing 16 study visits over 1 year and 3 months.