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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Antibodies, Monoclonal; Clemastine; Loratadine; Omalizumab

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