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

Completed · Phase 4

Conditions studied: Chronic Urticaria

In brief

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

Key facts

Study ID

NCT01701583

Run by

University of Colorado, Denver

People needed

10

Starts

2013-04-01

Expected to finish

2017-10-01

Last updated by the study team

2020-12-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University of Colorado Hospital — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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