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

NCT ID: NCT01701583

Last Updated: 2020-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Urticaria

Keywords

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Chronic Idiopathic Urticaria CIU Urticaria Chronic Hives Xolair

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omalizumab

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

Group Type EXPERIMENTAL

Omalizumab

Intervention Type DRUG

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

Interventions

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Omalizumab

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

Intervention Type DRUG

Other Intervention Names

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Xolair

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Dreskin, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Hospital

Denver, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 29671921 (View on PubMed)

Other Identifiers

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12-0780

Identifier Type: -

Identifier Source: org_study_id