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

Launched by NOVARTIS · Jun 1, 2007

Keywords

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Gender

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Eligibility criteria

• 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