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

This study is currently recruiting participants.
Verified June 2013 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: June 13, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Urticaria
 Drug: Omalizumab
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Omalizumab (Xolair) on the Basophil Proteome in Patients With Chronic Idiopathic Urticaria

Resource links provided by NLM:

MedlinePlus related topics: Hives
Drug Information available for: Omalizumab
U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omalizumab
Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
 Drug: Omalizumab
Other Name: Xolair

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701583

Contacts
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

Locations
United States, Colorado
University of Colorado Hospital Recruiting
Denver, Colorado, United States, 80045
Principal Investigator: Stephen Dreskin, M.D., Ph.D.            
Sub-Investigator: Jenny Stitt, M.D.            
Sponsors and Collaborators
University of Colorado, Denver
Genentech
Investigators
Principal Investigator: Stephen Dreskin, M.D., Ph.D. University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01701583     History of Changes
Other Study ID Numbers: 12-0780
Study First Received: October 3, 2012
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
Chronic Idiopathic Urticaria
CIU
Urticaria
Chronic Hives
Xolair

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on June 18, 2013