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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01701583
Recruitment Status : Completed
First Posted : October 5, 2012
Results First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.

Condition or disease Intervention/treatment Phase
Chronic Urticaria Drug: Omalizumab Phase 4

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Omalizumab (Xolair) on the Basophil Proteome in Patients With Chronic Idiopathic Urticaria
Study Start Date : April 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
Drug Information available for: Omalizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Omalizumab
Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
 Drug: Omalizumab
Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
Other Name: Xolair


Outcome Measures
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Primary Outcome Measures :
  1. Change in the Basophil Proteome [ Time Frame: Baseline through week 13 ]
    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.


Secondary Outcome Measures :
  1. Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab. [ Time Frame: Baseline through week 13 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701583


Locations
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United States, Colorado
University of Colorado Hospital
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Genentech, Inc.
Investigators
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Principal Investigator: Stephen Dreskin, M.D., Ph.D. University of Colorado, Denver
More Information
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Publications of Results:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01701583    
Other Study ID Numbers: 12-0780
First Posted: October 5, 2012    Key Record Dates
Results First Posted: December 4, 2020
Last Update Posted: December 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Chronic Idiopathic Urticaria
CIU
Urticaria
Chronic Hives
Xolair
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents