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

This study is currently recruiting participants.
Verified February 2014 by University of Colorado, Denver
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01701583
First received: October 3, 2012
Last updated: February 26, 2014
Last verified: February 2014

October 3, 2012
February 26, 2014
April 2013
December 2014   (final data collection date for primary outcome measure)
Change in the basophil proteome [ Time Frame: Baseline through week 13 ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01701583 on ClinicalTrials.gov Archive Site
Change in basophil proteome in responders to omalizumab compared to non-responders to omalizumab [ Time Frame: Baseline through week 13 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria
Effect of Omalizumab (Xolair) on the Basophil Proteome in Patients With Chronic Idiopathic Urticaria

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Urticaria
Drug: Omalizumab
Other Name: Xolair
Experimental: Omalizumab
Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
Intervention: Drug: Omalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
December 2014
December 2014   (final data collection date for primary outcome measure)

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 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.
Both
18 Years to 65 Years
No
Contact: Jenny Stitt, M.D. 303-724-7205 jenny.stitt@ucdenver.edu
Contact: Stephen Dreskin, M.D., Ph.D. 303-724-7190 Stephen.dreskin@ucdenver.edu
United States
 
NCT01701583
12-0780
Yes
University of Colorado, Denver
University of Colorado, Denver
Genentech
Principal Investigator: Stephen Dreskin, M.D., Ph.D. University of Colorado, Denver
University of Colorado, Denver
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP