Status:
COMPLETED
Effect of Anti-IgE in Chronic Urticaria
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Urticaria
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ta...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00130234
Start Date
November 1 2004
End Date
September 1 2007
Last Update
May 7 2008
Active Locations (1)
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1
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224-6821