Study

A study to evaluate efficacy of remibrutinib compared to dupilumab at early timepoints in adults with chronic spontaneous urticaria inadequately controlled by second generation H1-antihistamines

The purpose of this randomized, double-blind, double-dummy study is to evaluate efficacy of remibrutinib in comparison to dupilumab in treating adult participants who have Chronic Spontaneous Urticaria (CSU). The study will compare the efficacy of remibrutinib with dupilumab to see which one works better in helping people with CSU who haven't found relief with use of second-generation antihistamines.

Why this Research Matters

You will be in the study for up to 28 weeks and during that time, you will need to visit the Study Doctor up to 8 times, which is about once every two weeks. At the study visits, the following procedures should happen: a physical examination, vital signs, taking blood and urine samples, and ECG (a heart tracing recording). At the first visit (screening), you will also be asked about your medical history and any medications that you are currently taking. Every day during the core study treatment period (up to Week 12), you will be asked to record information in the morning and in the evening about your CSU symptoms through a form called a "participant recorded outcome measure". You will be given an electronic device to record this information. This device will be provided to you at your first site visit. You will also be asked to record information about your background medication, if you had to take additional medication for your CSU (called "rescue medication"), or if you had to contact your doctor because of your CSU.

Who can Participate

Adult

Participants eligible for inclusion in this study must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Male and female adult participants equal to or greater than 18 years of age at the time of signing the informed consent 3. CSU duration for equal to or greater than 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation) 4. Diagnosis of CSU inadequately controlled by sgH1-AH at the time of randomization 5. Documentation of hives within three months before randomization (either at screening and/or at randomization; or documented in the participants medical history) 6. Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol 7. Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1) Please contact the study team if you have any questions about whether you are eligible for this study.