Effect of Anti-IgE in Chronic Urticaria

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT00130234

Collaborator

Genentech, Inc. (Industry)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being done to find out if a drug called Xolair (omalizumab), an anti-IgE antibody, is safe and effective for people with chronic urticaria (hives) with persistent symptoms in spite of taking antihistamines.

Condition or Disease	Intervention/Treatment	Phase
Urticaria	Drug: Xolair® (Omalizumab)	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Effect of Anti-IgE in Chronic Urticaria

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.