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

University of Colorado, Denver10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Urticaria

Interventions

OmalizumabDRUG

Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Colorado Hospital

Denver, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline through week 13

Secondary Outcomes

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.

Time frame: Baseline through week 13

Data from ClinicalTrials.gov

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