Bullous Pemphigoid Clinical Trial
Official title:
An Open Label Case Series on the Effects of Xolair (Omalizumab) in Bullous Pemphigoid
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.
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 current treatment for bullous pemphigoid is non-specific
immunosuppression, causing great morbidity in these patients. Recently, pathogenic
Immunoglogulin Class E autoantibodies have been identified in these patients. Development of
a more targeted approach to treatment may reduce morbidity.
Methodology: This is a pilot, open-label case-control study. Patients treated with
Omalizumab (Xolair) will be compared to patients receiving standard treatment with
prednisone.
Number of centers and patients: This is a single center study that will enroll 12 patients.
Population: Bullous pemphigoid patients, meeting clinical, histological and immunologic
criteria for the disease will be enrolled. Pregnant women, children less than 18 years of
age, and patients unable to give consent will be excluded from this preliminary study.
Investigational drug: Xolair® (Omalizumab)
Study duration: 24 weeks: 16 weeks of active treatment, 8 additional weeks of observation
Evaluation criteria: Primary: 1. Time to cessation of new blister formation. 2. Percent body
surface area of skin involved before and after treatment 3. Total and average daily dose of
prednisone required in 30, 60 and 180 days after starting Xolair. Secondary: 1. Number of
circulating eosinophils 2. Measurement of circulating anti-BMZ (basement membrane zone)
autoantibodies 3. Histamine release assay.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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