Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Genentech, Inc.
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• Chronic urticaria (hives) for more than 6 weeks.

• No improvement with standard doses of antihistamines (loratadine 10 mg daily, desloratadine 5 mg daily, fexofenadine 180 mg daily, cetirizine 10 mg daily, or levocetirizine 5 mg daily)

Exclusion Criteria:

• Taken any oral steroids for 1 month prior to beginning the study.

• Taken any other immunomodulatory drugs (sulfasalazine, hydroxychloroquine, cyclosporine, methotrexate) for 1 month prior to beginning the study.

• Physical urticaria as a primary diagnosis.

• Known allergic precipitant of urticaria such as foods.

• Urticarial Vasculitis.

• Anemia.

• Asthma.

• Serum Immunoglobulin E (IgE) >700 IU/ml.

• Women of childbearing potential not using contraception method(s), as well as women who are pregnant and/or breastfeeding.

• Known sensitivity to omalizumab or this class of drug.

• Use of any other investigational agent in the last 1 month.

• Untreated intercurrent illness.