This study is comparing how well remibrutinib (Rhapsido) and dupilumab (Dupixent) work in adults with Chronic Spontaneous Urticaria (CSU).
Chronic Spontaneous Urticaria (CSU) is a condition that causes itchy hives that last for more than 6 weeks without a known cause. These hives can be uncomfortable and frustrating to live with. This study is comparing two treatments, remibrutinib (Rhapsido) and dupilumab (Dupixent), to learn how well they work for people with CSU. Before you can join the study, you will come to a clinic visit that includes a physical exam, blood and urine tests, heart tests (ECG), and answering questions about your health. If you join the study, you will be randomly assigned to one of two groups. One group will take remibrutinib tablets and a placebo injection, while the other group will take dupilumab injections and placebo tablets. A placebo looks like the study drug but contains no active medicine. You will not be able to choose your group. Neither you nor the study team will know which treatment you are getting. You will take your study treatment for 12 weeks and use an electronic diary to record your CSU symptoms each morning and evening. You will also record any medications you take for CSU and any CSU-related healthcare visits. Throughout the study, the study team will check your health through physical exams, blood and urine tests, and heart tests (ECG). You will be in the study for 4 months and attend 8 clinic visits. You may earn up to $816 for completing all study visits.
You may be able to join this study if you are 18 years or older and have had CSU for at least 6 months before joining the study. You must also have CSU that persists despite using standard treatment. The study team can talk to you about any eligibility related questions you have and decide whether you can join this study.
Protocol Number: 25-0964
Principal Investigator