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

Chronic Urticaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701583
• Other study ID #: 12-0780
• Status: Completed
• Phase: Phase 4
• Start date: April 2013
• Est. completion date: October 2017

Study information

• Verified date: November 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Urticaria
• Urticaria

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stitt JM, Dzieciatkowska M, Edwards MG, Hansen K, Hedlund G, Dreskin SC. The basophil proteome in chronic spontaneous urticaria distinguishes responders to omalizumab from non-responders. Clin Exp Allergy. 2018 Jul;48(7):898-901. doi: 10.1111/cea.13149. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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