Effect of Anti-IgE in Chronic Urticaria

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being done to find out if a drug called Xolair (omalizumab), an anti-IgE antibody, is safe and effective for people with chronic urticaria (hives) with persistent symptoms in spite of taking antihistamines.

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

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Genentech, Inc.
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• Males and non-pregnant, non-breastfeeding females

• Chronic urticaria defined as symptoms >50% of the days or 3 days per week for more than 12 weeks

• History of angioedema

• Chronic daily therapy with anti-histamines and stable doses of antihistamines for at least 4 weeks.

• High baseline score for pruritis (at least 2 on a 3 point scale)

• No other etiology identified for chronic urticaria such as drug-related or physical urticaria as determined by history, physical examination and laboratory studies

Exclusion Criteria:

• Concomitant use of systemic corticosteroids for 1 month prior to enrollment. Topical steroid use will not be permitted, but inhaled topical steroids are allowed.

• Current use of immunosuppressive medication (cyclosporine, IVIg, methotrexate, cyclophosphamide). Any such medication will be discontinued for at least 6 weeks before screening.

• Treatment with any investigational agent within 30 days of screening

• Previous treatment with omalizumab

• Recent history of drug or alcohol abuse (within 3 years prior to study)

• Active atopic dermatitis requiring the use of topical steroid agents

• Clinically relevant cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other major systemic disease making the protocol or interpretation of the study results difficult.