Status:
COMPLETED
Efficacy and Safety of Omalizumab in Bullous Pemphigoid
Lead Sponsor:
University of Iowa
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Bullous Pemphigoid
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective is to test the safety and efficacy of Xolair in the treatment of the autoimmune blistering disease, bullous pemphigoid (BP). This is a pilot, open label case-control study. Pati...
Detailed Description
Objectives: The primary objective is to test the safety and efficacy of Omalizumab (Xolair) in the treatment of the autoimmune blistering disease, bullous pemphigoid (BP). Study Rationale: The curren...
Eligibility Criteria
Inclusion
- Patients must have the clinical and histological findings consistent with bullous pemphigoid. Clinically this is defined as urticarial plaques and/or vesicles and bullae. Histologically patients must show characteristic eosinophilic spongiosis and/or subepidermal separation of the skin consistent with BP.
- Patients must have either a positive direct (IgG and/or C3 at the BMZ) or indirect (IgG on the roof of salt-split skin) immunofluorescence microscopy features of pemphigoid.
- Patients of both sexes, all races and ethnic backgrounds that are 18 years of age or older will be eligible to participate in this study.
- Patients much have more than 5% total body surface involved, since patients with less extensive disease are often treated with topical measures only.
Exclusion
- Women of childbearing potential not using the contraception method(s) specified during this study. Women of childbearing potential must use proven birth control methods (such as - abstinence, birth control pills, intrauterine device, barrier method combined with gel or foam with spermicide, tubal ligation, or a partner who has had a vasectomy).
- Women who are pregnant or breastfeeding.
- Patients under the age of 18.
- Patients unable to give informed consent.
- Known sensitivity to study drug(s) or class of study drug(s).
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
- Any cancer other than non-melanoma skin cancer in the past 5 years.
- All non-melanoma skin cancers must have been adequately treated at entrance to the study.
- Use of any other investigational agent in the last 30 days.
- Treatment with prednisone in the past 2 weeks.
- Weight or serum IgE levels that place the patient outside standard dosing guidelines for Xolair.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00472030
Start Date
August 1 2007
End Date
December 1 2010
Last Update
October 16 2012
Active Locations (1)
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1
University of Iowa, Department of Dermatology
Iowa City, Iowa, United States, 52242