Effect of Anti-IgE in Chronic Urticaria

Completed · Phase 2

Conditions studied: Urticaria

In brief

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.

Key facts

Study ID

NCT00130234

Run by

Johns Hopkins University

People needed

20

Starts

2004-11-01

Expected to finish

2007-09-01

Last updated by the study team

2008-05-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins Asthma and Allergy Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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