Efficacy and Safety Study of Omalizumab (Xolair®) to Treat Chronic Urticaria

Launched by CLINICA UNIVERSIDAD DE NAVARRA, UNIVERSIDAD DE NAVARRA · Oct 24, 2012

Keywords

ClinConnect Summary

The objective of the present study is to demonstrate with an adequate methodology the efficacy and safety of Omalizumab for a new indication that is chronic autoimmune and no autoimmune urticaria. For that purpose, The investigators will perform a Multicenter double- blinded, placebo- controlled, randomized cross-over (2x2) trial. The investigators will include 20 patients including both female and male adults non respondent to antihistamines at supra therapeutic dose. Efficacy will be evaluated through the Urticaria Activity Score 7 (UAS7), Chronic Urticaria Quality of Life validated quest...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult female and male patients
• • Diagnosis of chronic autoimmune or non autoimmune urticaria
• • The investigators defined chronic urticarial as the occurrence of widespread daily or almost daily wheals for at least 6 weeks, which may be accompanied by angioedema. While the wheals are transient, the resolution of angioedema is slower than wheals and could take up to 72 hours.
• • No response to therapeutic doses of antihistamines
• • The investigators define therapeutic doses of antihistamines the maximal dose included in the drug labeling
• • Written informed consent.
• Exclusion Criteria:
• • Urticaria vasculitis or any kind of physical urticaria
• • Total IgE value above 700 UI/l
• • Pruritus related to dermatitis or other skin condition
• • Any systemic disease that do not allow to follow up or interpretation data
• • Omalizumab treatment within the previous 12 months
• • Treatment with corticosteroids or immunosuppressive drugs within the previous 4 weeks
• • Any exclusion criteria included in the drug labeling
• • Any other condition that do not allow to accomplish the clinical trial requisites as use of drugs, alcohol.