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

November 10, 2020 updated by: University of Colorado, Denver

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Xolair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline through week 13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline through week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Stephen Dreskin, M.D., Ph.D., University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (ESTIMATE)

October 5, 2012

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-0780

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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