Woman and Man
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Extract
The primary objective is to demonstrate the superiority of omalizumab 300 mg versus placebo in patients with moderate to severe CSU regarding QoL measures. This will be done by evaluating the change of total CU-Q2oL scores in moderate to severe CSU patients with a history of angioedema and insufficient treatment response to a high dose of nsH1-antihistamines (second line treatment: up to 4x of the approved nsH1-Antihistamine dose). Scores will be calculated from baseline (visit 2) to week 28 (visit 9) with secondary objective(s).
Inclusion criteria
- moderate to severe chronic spontaneous urticaria with angioedema