Efficacy and Safety of Omalizumab in Bullous Pemphigoid

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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. Patients treated with Xolair will be compared to patients receiving standard treatment with prednisone.

The enrollment period for the study is 24 weeks: 16 weeks active treatment and 8 additional weeks of observation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Iowa
• Collaborator: Genentech, Inc.
• Treatments: Omalizumab; Prednisone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.