At a glance
ClinicalIndex Comparison Record- ✓Clinical and histological findings consistent with bullous pemphigoid: urticarial plaques and/or vesicles and bullae with eosinophilic spongiosis and/or subepidermal separation.
- ✓Positive direct immunofluorescence (IgG and/or C3 at the basement membrane zone) or indirect immunofluorescence (IgG on the roof of salt-split skin).
- ✓Age ≥18 years.
- ✓More than 5% total body surface area involved.
- ✕Pregnant or breastfeeding women.
- ✕Known sensitivity to omalizumab or monoclonal antibody class.
- ✕Cancer history other than non-melanoma skin cancer in the past 5 years.
- ✕Use of any investigational agent within the last 30 days.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Case Series on the Effects of Xolair (Omalizumab) in Bullous Pemphigoid
In Brief
A Phase 4 clinical trial evaluating Omalizumab and prednisone for Bullous Pemphigoid. Completed, enrolled 2 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.