Xolair® (Omalizumab) in Urticaria - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Urticaria

Intervention / Treatment

Drug: Xolair® (Omalizumab)

Detailed Description

Omalizumab (Xolair®) is a recombinant humanized monoclonal antibody that binds specifically to the FcEpsilonR1 binding site on human IgE. The binding of omalizumab inhibits the ability of IgE to bind to basophils or mast cells. Free IgE levels fall by 89% and 98% over 16 and 24 weeks of therapy respectively (Busse, 2001). Total IgE levels rise in patients treated with omalizumab though almost all IgE is bound and thus inactive. Omalizumab has also been shown to decrease expression of the FcEpsilonR1 receptor on both basophils and mast cells (Beck et al, 2004). Omalizumab recently received FDA approval for the treatment of moderate to severe persistent allergic asthma in pediatric (12 years of age and above) and adult patients. Studies have also shown efficacy in the treatment of allergic rhinitis and similar anti-IgE compounds have been efficacious as food allergy therapeutics (Casale, 2001, and Leung 2003).

Given the efficacy of omalizumab in the treatment of moderate to severe allergic asthma, the researchers will conduct a double-blind study to evaluate the safety and efficacy of omalizumab in a small number of patients with chronic urticaria with persistent symptoms in spite of background antihistamine therapy. Omalizumab is currently not indicated for patients with chronic urticaria. The primary hypothesis is that omalizumab will lead to a reduction in serum IgE levels and blood basophil high affinity IgE receptor expression in subjects with chronic idiopathic urticaria. Additionally, clinical outcomes such as quality of life, symptoms scores, and medication use will be explored. This study should allow for further understanding of the role IgE plays in chronic urticaria.

Study Type

Interventional

Enrollment

20

Phase

Phase 2

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
- Maryland
  - Baltimore, Maryland, United States, 21224-6821
    - Johns Hopkins Asthma and Allergy Center

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Males and non-pregnant, non-breastfeeding females
Chronic urticaria defined as symptoms >50% of the days or 3 days per week for more than 12 weeks
History of angioedema
Chronic daily therapy with anti-histamines and stable doses of antihistamines for at least 4 weeks.
High baseline score for pruritis (at least 2 on a 3 point scale)
No other etiology identified for chronic urticaria such as drug-related or physical urticaria as determined by history, physical examination and laboratory studies

Exclusion Criteria:

Concomitant use of systemic corticosteroids for 1 month prior to enrollment. Topical steroid use will not be permitted, but inhaled topical steroids are allowed.
Current use of immunosuppressive medication (cyclosporine, IVIg, methotrexate, cyclophosphamide). Any such medication will be discontinued for at least 6 weeks before screening.
Treatment with any investigational agent within 30 days of screening
Previous treatment with omalizumab
Recent history of drug or alcohol abuse (within 3 years prior to study)
Active atopic dermatitis requiring the use of topical steroid agents
Clinically relevant cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other major systemic disease making the protocol or interpretation of the study results difficult.

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: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Collaborators and Investigators

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

Sponsor

Johns Hopkins University

Collaborators

Genentech, Inc.

Investigators

Principal Investigator: Sarbjit Saini, M.D., Johns Hopkins Asthma and Allergy Center, Division of Allergy and Clinical Immunology

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

November 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

August 12, 2005

First Submitted That Met QC Criteria