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

University of Colorado Denver (CU Denver)

Status and phase

Completed

Phase 4

Conditions

Chronic Urticaria

Treatments

Drug: Omalizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01701583

12-0780

Details and patient eligibility

About

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

Full description

The purpose of this study is to evaluate for changes in the proteins produced in white blood cells (basophils) in patients with chronic hives who are treated with and respond to omalizumab.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.