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

Study Overview
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Brief Summary
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This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.

Detailed Description
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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.

Official Title
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Effect of Omalizumab (Xolair) on the Basophil Proteome in Patients With Chronic Idiopathic Urticaria

Conditions
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Chronic Urticaria

Intervention / Treatment
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* Drug: Omalizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omalizumab<br>Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center. | Drug: Omalizumab<br>* Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.<br>* Other names: Xolair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Basophil Proteome | In patients with chronic urticaria who respond clinically to omalizumab, the proteome of blood basophils will be measured at baseline (pre-treatment) and at weeks 6 and 13 (post-treatment). The number of participants with a change observed in basophil proteome out of the total number of participants, stratified by responders and non-responders, is reported. | Baseline through week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab. | Change in basophil proteome in responders to omalizumab compared to non-responders to omalizumab. However, there was insufficient data from weeks 6 and 13 to analyze this outcome. | Baseline through week 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Idiopathic Urticaria, CIU, Urticaria, Chronic Hives, Xolair