Overview

This trial is active, not recruiting.

Condition chronic urticaria
Treatment omalizumab
Phase phase 4
Target IgE
Sponsor University of Colorado, Denver
Collaborator Genentech, Inc.
Start date April 2013
End date April 2016
Trial size 12 participants
Trial identifier NCT01701583, 12-0780

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
omalizumab Xolair
Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.

Primary Outcomes

Measure
Change in the basophil proteome
time frame: Baseline through week 13

Secondary Outcomes

Measure
Change in basophil proteome in responders to omalizumab compared to non-responders to omalizumab
time frame: Baseline through week 13

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Effect of Omalizumab (Xolair) on the Basophil Proteome in Patients With Chronic Idiopathic Urticaria
Principal investigator Stephen Dreskin, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.