CSU is a condition that causes your immune cells to mistakenly receive signals to swarm and attack skin cells, leading to inflammation. It results in itchy hives and swelling that come and go without a clear reason. People with CSU often refer to their condition as having “hives” or “chronic hives.” It can be very uncomfortable and affect sleep and daily life.
Every day can feel uncertain when you live with chronic spontaneous urticaria (CSU). Sudden flare-ups can disrupt almost any activity leaving you with relentless discomfort. We're currently evaluating a study medicine that is a pill you swallow daily to see if it can potentially help get better control of CSU symptoms. If you are interested in exploring options, we invite you to learn about our clinical trial.
We are looking for people living with CSU, often referred to as chronic hives, to see if a study medicine that is a pill you swallow daily can potentially help control symptoms and reduce flare-ups. If you choose to take part in this clinical trial, you’ll receive care from a team of dedicated specialists who could help us continue to make progress for CSU research.
Who may participate
You may be able to take part in this clinical trial if you are over 18 years or older, have been diagnosed with CSU at least 3 months ago, or are currently taking antihistamines that are not controlling your CSU symptoms.
There will be other requirements that the study team will talk about with you.
Joining a clinical trial is an important and personal decision. We thank you for considering taking part as something that may be right for you.
Condition
Chronic spontaneous urticaria (CSU)
Age
18 years and older
Sex
Male or Female
Each clinical trial has its own guidelines for who can take part, called eligibility criteria. However, only the study team can determine if you are able to take part in the clinical trial.
What to expect
If you decide to take part in this clinical trial, you will start the Screening Period where the study team will see if this clinical trial is a good fit for you.
The Screening Period takes about 1 month, followed by a 6-month Treatment Period. After you have finished the Treatment Period, there will be a 1-month Follow-up Period. The clinical trial will last for a total of around 8 months with 8 in-person visits, plus 1 follow-up visit that can be a phone call.
For the first 3 months of Treatment Period, 2/3 (66%) of participants will receive the study medicine and 1/3 (33%) will receive the placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. However, ALL participants will receive the study medicine after the first 3 months.
You may be able to take part in this clinical trial if you are over 18 and have uncontrolled chronic spontaneous urticaria (CSU) despite taking medicine. You may also be able to take part if you have never taken medicine for CSU.
Length of study treatment
Up to 6 months
Number of study visits
8 in-person visits, plus 1 follow-up visit that can be a phone call
Long-term follow-up
You will receive a phone call approximately 1 month after the Treatment Period
Benefits of this Clinical Trial
Benefits of this Clinical Trial
If you have CSU, often referred to as chronic hives, this clinical trial offers the opportunity to explore a potential treatment that may better control your symptoms and reduce flare-ups.
Additionally,
- You will receive care from dedicated specialists
- All clinical trial-related care, including study medicine, will be provided at no cost
- Travel support related to the the clinical trial may also be provided
- You will gain access to the latest research and may help advance the future of CSU treatments
About chronic spontaneous urticaria (CSU)
About chronic spontaneous urticaria (CSU)
Frequently asked questions
Why is this research important?
The clinical trial will assess a potential new treatment for CSU, often referred to as chronic hives, hoping to improve symptoms and reduce flare-ups.
Who can take part in the clinical trial?
Adults over the age of 18 who are diagnosed with CSU and are not responding to their current antihistamines are able to take part in the clinical trial. A doctor will assess each potential participant to ensure the clinical trial is a good fit.
Will I have to pay for anything during the clinical trial?
No, all clinical trial-related care, including study medication, will be provided at no cost.
Will I get the study medicine or a placebo?
For the first 3 months of study treatment, 2 out of 3 (66%) participants will receive the study medicine and 1 out of 3 (33%) will receive the placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.
However, all participants will receive the study medicine after the first 3 months.
What types of tests can I expect during the clinical trial?
Your study doctor will conduct a physical exam and a series of tests similar to those you may have at a regular doctor’s visit.
