NCT00472030

Efficacy and Safety of Omalizumab in Bullous Pemphigoid

An Open Label Case Series on the Effects of Xolair (Omalizumab) in Bullous Pemphigoid

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Bullous Pemphigoid

Interventions

Type	Name	Description
DRUG	Omalizumab	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.
DRUG	prednisone	Prednisone, to a maximum dose of 0.5 mg/kg/day.

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-05-10
• Last updated: 2012-10-16
• Results posted: 2012-10-16

Locations

1 site across 1 country: United States