(Those who have already started treatment with dupilumab will not be eligible to enroll.)
NOTE: The study participant will continue to see their own treating physician for their regularly scheduled visits while taking part in this study. There are no additional in-person study visits.
Since this is an “observational only” study it will not affect your doctor’s (or your child’s doctor’s) chronic spontaneous urticaria treatment plan. Additionally, since the information being collected will be gathered remotely, you (or your child) will not need to go to a clinical trial site. You will, however, need to sign an informed consent form (ICF) indicating that you agree to participate (or that you will allow your child to participate) in the study.
If you agree, data about the study participant and their chronic spontaneous urticaria will be collected from medical records and from questionnaires that participants will fill out about their condition and how it affects their quality of life, for example.
Your/your child’s regular treating physician will NOT need to perform any additional patient assessments or lab tests. Any assessments of the medical condition will occur at regularly scheduled doctor’s appointments.
Study participation is expected to last about 24 months.
Chronic spontaneous urticaria (a type of hives or rash) is characterized by “wheals” and angioedema (or defined irregular swellings on the skin) that suddenly occur over a period of at least 6 weeks. During these flare-up periods, the wheals are very itchy, though usually resolve in under 24 hours. Even so, they tend to recur on a daily basis and are worse at night and can affect sleep.
Hives most commonly occur on the back, arms and legs and they can be painful (may burn or sting) as well as itch.
Believed to be due to an overactive immune system (i.e., an autoimmune disorder), chronic urticaria typically lasts for several years before resolving on its own.
Dupilumab is a medicine used to treat chronic spontaneous urticaria in adults and teens aged 12 and older who still have symptoms despite taking antihistamines. It was approved by the FDA on April 18, 2025. Dupilumab works by blocking certain proteins in the body that cause inflammation, which helps reduce symptoms of allergic diseases.
First-line treatment for chronic spontaneous urticaria usually involves taking higher doses of antihistamines, but only about half get relief with this approach. As an injectable (shot), dupilumab offers a new option for those who continue to have symptoms.
Although dupilumab has been studied in chronic spontaneous urticaria clinical trials, little is known about how well it works for the treatment of the condition in the real-world setting. Thus, the main purpose of this study is to gather information on how the drug is prescribed for a CSU rash. For example, we want to learn which physician specialties (such as dermatologists) are prescribing it and to which types of patients, how long it’s taken, and how well it works in the real world.
Researchers also want to learn what other treatments people have tried for their CSU, how taking dupilumab affects their quality of life, and how satisfied they are, overall, with dupilumab.
Again, participation in the study will last about two years, however, enrollees can withdraw from the study at any time and for any reason.