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

Primary Purpose

Chronic Urticaria

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omalizumab
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Urticaria focused on measuring Chronic Idiopathic Urticaria, CIU, Urticaria, Chronic Hives, Xolair

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omalizumab

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 3, 2012
Last Updated
November 10, 2020
Sponsor
University of Colorado, Denver
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01701583
Brief Title
Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria
Official Title
Effect of Omalizumab (Xolair) on the Basophil Proteome in Patients With Chronic Idiopathic Urticaria
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Urticaria
Keywords
Chronic Idiopathic Urticaria, CIU, Urticaria, Chronic Hives, Xolair

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omalizumab
Arm Type
Experimental
Arm Description
Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Other Intervention Name(s)
Xolair
Intervention Description
Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
Primary Outcome Measure Information:
Title
Change in the Basophil Proteome
Description
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.
Time Frame
Baseline through week 13
Secondary Outcome Measure Information:
Title
Change in Basophil Proteome in Responders to Omalizumab Compared to Non-responders to Omalizumab.
Description
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.
Time Frame
Baseline through week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Dreskin, M.D., Ph.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29671921
Citation
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. Epub 2018 May 20. No abstract available.
Results Reference
result

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

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