Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy

Inclusion Criteria:

• Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1-antihistaminetreatment

• Presence of itch an hives for more than 6 weeks

• UAS7 score of more than 14 (range 0-42)

• Patient has history of insufficient response to 4x of the approved dose ofH1-antihistamines

• CSU diagnosis for more than 6 months

• Angioedema at least 4x in the last 6 months

Exclusion Criteria:

• Patients with non urticaria associated angioedema

• History of hypersensitivity to omalizumab or the rescue medication or to drugs ofsimilar chemical structure

• Evidence of parasitic infection

• Previous treatment with omalizumab within the last 6 months prior to screening

• History of anaphylactic shock

• Woman who are pregnant or breast feeding

• Other protocol-defined inclusion/exclusion criteria may apply.