Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria

A Randomized, 24 Weeks, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Omalizumab in Adult Patients With Chronic Urticaria Who Exhibit IgE Against Thyroperoxidase

This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.

Inclusion criteria:

• Males or females from 18-70 years of age
• Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700 IU/mL
• Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to randomization or time of pre-screening
• Diagnosis of moderate to severe chronic urticaria
• Subject's current episode of chronic urticaria according to the European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum (EAACI/GA2LEN/EDF) guideline at the time of screening
• Current episode of chronic urticaria has not responded to the approved marketed dose of antihistamine for 2 weeks or longer
• Urticaria activity score (UAS) ≥ 0 at any of the 7 days of the first section of the screening period
• UAS7 ≥ 10 at the time of randomization

Exclusion criteria:

• Females of child-bearing potential or breast feeding
• Present or past medical conditions that could have interfered with the study results
• Randomized into any other omalizumab study or who had received omalizumab
• Received investigational drugs within 30 days of enrollment