Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria
Status:
Unknown status
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
Efficacy of omalizumab in chronic spontaneous urticaria had been demonstrated in phase II and
phase III studies. Clinical symptoms and signs had been significantly reduced with omalizumab
as doses of 150 mg and 300 mg at 4-week intervals in patients with chronic spontaneous
urticaria who remained symptomatic despite antihistamine treatment. Omalizumab had an onset
of effect within a week after initiation. Thus, the investigators hypothesize that omalizumab
will be effective in the treatment of severe acute urticaria as add on therapy with a fast
onset of action. Objective:To investigate the efficacy and safety of omalizumab in the
treatment of severe acute urticaria Study design: This prospective, interventional,
single-arm open label study will recruit patients with severe acute urticaria from emergency
departments, hospitalized and outpatient departments. The included patients will receive a
single subcutaneous dose of 300mg omalizumab therapy. The efficacy of omalizumab will be
evaluated by physical examination and assessed by Urticaria Activity Score (UAS) at baseline,
1 hour, Day 1, Day3, Day 7, and 6 weeks after omalizumab therapy. The frequency and severity
of treatment-emergent adverse events will also be evaluated