Efficacy and Safety of Omalizumab in Bullous Pemphigoid
Condition: Bullous Pemphigoid
MeSH terms: Pemphigoid, Bullous
Intervention: Omalizumab; prednisone
Intervention description: Patients will be treated with 150-375 milligrams of Omalizumab (Xolair), based on their baseline weight and serum Immunoglobulin E levels. Omalizumab will be administered subcutaneously on Day 1, and on Week 2, 4, 6, 8, 10, 12 and 14 treatment.; Prednisone, to a maximum dose of 0.5 mg/kg/day.
Intervention MeSH terms: Omalizumab; Prednisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bullous pemphigoid; omalizumab; xolair; IgE; autoimmunity; skin disease

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.
    

Eligibility 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.