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Completed

NCT Number: NCT01701583

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

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

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Key information

Conditions

Chronic Urticaria Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Hospital

Denver, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omalizumab

Drug

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

Other names: Xolair

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Oct 5, 2012
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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