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

• Status: Completed
• Trial end date: 2014-05-09
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Omalizumab

Criteria

Inclusion Criteria:

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

• 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 of H1-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 of similar 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.