The purpose of this open-label study is to assess the efficacy and safety of a novel treatment algorithm for sequencing remibrutinib and omalizumab in the treatment of adult participants with chronic spontaneous urticaria (CSU) who are inadequately controlled by second-generation H1-antihistamines (sgH1-AH).
Male and female adults (age ≥18 years) at the time of signing the informed consent.
CSU duration for ≥2 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation).
The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of sgH1-AH during this time period.
UAS7 score (range: 0-42) ≥16.
Previous use of remibrutinib, other Bruton's tyrosine kinase (BTK) inhibitors or prior exposure to biologics with any effect in CSU (e.g., ligelizumab, omalizumab, dupilumab, barzolvolimab).
Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or hematological disorders, or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence by the participant.
Significant bleeding risk or coagulation disorders.
History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAIDs), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion).
Parallel
Remibrutinib
DrugRemibrutinib 25 mg twice a day.
Omalizumab
DrugOmalizumab 300 mg every 4 weeks.
Proportion of participants achieving Urticaria Activity Score over 7 days (UAS7) ≤6 (yes/no)
UAS7 is a validated patient-reported measure of chronic spontaneous urticaria disease activity over 7 days. It is calculated as the sum of the weekly Hives Severity Score (HSS7) and the weekly Itch Severity Score (ISS7) and ranges from 0 to 42. Lower scores indicate lower disease activity / better disease control, and a score of ≤6 indicates well-controlled disease. HSS7 and ISS7 are each derived from daily diary entries over the 7 days preceding the visit.
Proportion of participants achieving UAS7 ≤6 (yes/no)
UAS7 is calculated as the sum of the HSS7 and ISS7 and ranges from 0 to 42. Lower scores indicate lower disease activity / better disease control, and a score of ≤6 indicates well-controlled disease. HSS7 and ISS7 are each derived from daily diary entries over the 7 days preceding the visit.
Proportion of participants achieving UAS7 =0 (yes/no)
UAS7 is calculated as the sum of the HSS7 and ISS7 and ranges from 0 to 42, with 0 indicating no urticaria activity over the 7-day assessment period and higher scores indicating worse disease activity.
Proportion of participants achieving Angioedema Activity Score over 7 days (AAS7) =0.
AAS7 is a validated tool assessing angioedema activity, recorded once daily in the evening in the eDiary. If no angioedema is reported on a given day, the daily score is 0. Weekly AAS7 scores range from 0 to 105, with higher scores indicating greater angioedema severity; therefore, 0 represents absence of angioedema.
Proportion of participants achieving of Dermatology Life Quality Index (DLQI) =0/1
DLQI is a 10-item dermatology-specific quality-of-life instrument assessing the impact of skin disease over the previous 7 days. The total score ranges from 0 to 30, with higher scores indicating worse disease-related quality of life. A score of 0-1 corresponds to no effect on the participant's life.
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