Chronic Spontaneous Urticaria Clinical Trial
Official title:
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.
The primary objective of the study is to rule out an increase of >3mmHg in 24-hour average Systolic Blood Pressure at steady state (Week 4) compared to baseline. ABPM was chosen for the blood pressure assessment in this trial as recommended by the FDA for drugs intended for chronic use (Assessment of Pressor Effects of Drugs Guidance for Industry (FDA 2022)).
The primary objective of the study is to rule out an increase of >3mmHg in 24-hour average Systolic Blood Pressure at steady state (Week 4) compared to baseline. ABPM was chosen for the blood pressure assessment in this trial as recommended by the FDA for drugs intended for chronic use (Assessment of Pressor Effects of Drugs Guidance for Industry (FDA 2022)). It allows the observation over a 24-hour period and the measure of an individual's blood pressure throughout an entire day. This ABPM study will be performed in a patient population similar to the ongoing Phase 3 studies. The study duration will be up to 20 weeks. The treatment duration will be up to 12 weeks and the visit frequency will be once every 4 weeks with additional 2 visits for application of the ABPM device before baseline and Week 4 visits. ;
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