A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.

Ki vehet részt

• Signed informed consent obtained prior to participation in the study
• Male and female adult participants >= 18 years of age
• CSU duration for >= 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation)
• Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of baseline (Day 1)
• Documentation of hives within three months before baseline (either at screening and/or at baseline (Day 1); or documented in the participants' medical history)
• Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the protocol
• Participants had no more than 2 missing UPDD entries (either morning or evening) in the 7 days prior to baseline (Day 1)

Ki nem vehet részt

• Participants taking/requiring medications prohibited by the protocol (including those known to interfere with blood pressure assessments in the study)
• Ongoing or past history of hypertension and/or SBP >= 140 or =< 90 OR DBP >= 90 or =< 60 mmHg at screening
• Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease 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 of the participant
• Participants unable to tolerate 24-hour ambulatory blood pressure measurement using automatic ABPM device
• Participants working night shifts