Efficacy and Safety of Omalizumab in Bullous Pemphigoid
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.
Description
Objectives: The primary objective is to test the safety and efficacy of Xolair in the treatment of the autoimmune blistering disease, bullous pemphigoid (BP).
Study Rationale: The current treatment for BP is non-specific immunosuppression, causing great morbidity in these patients. Recently, pathogenic IgE class 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 Xolair will be compared to patients receiving standard treatment with prednisone.
Number of centers & 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 < 18, and patients unable to give consent will be excluded from this preliminary study.
Investigational drug: Xolair® (Omalizumab)
Study duration: 24 weeks: 16 weeks active treatment, 8 additional weeks of observation
Evaluation criteria: Primary: 1. Time to cessation of new blister formation. 2. Percent body surface 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. circulating eosinophils 2. Measurement of circulating anti-BMZ (basement membrane zone) autoantibodies 3. Histamine release assay.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Bullous Pemphigoid
Intervention
omalizumab, prednisone
Location
University of Iowa, Department of Dermatology
Iowa City
Iowa
United States
52242
Status
Recruiting
Source
University of Iowa
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00472030
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Pemphigoid Gestationis
An itching, autoimmune, bullous SKIN disease that occurs during the last two trimesters of PREGNANCY and PUERPERIUM. It also affects non-pregnant females with tissue of PLACENTA origin, such as CHORIOCARCINOMA; or HYDATIDIFORM MOLE. It exhibits antigenic and clinical similarity to bullous pemphigoid (PEMPHIGOID, BULLOUS). This disease does not involve herpes viruses (old name, herpes gestationis).
Pemphigoid, Bullous
A chronic and relatively benign subepidermal blistering disease usually of the elderly and without histopathologic acantholysis.
Pemphigoid, Benign Mucous Membrane
A chronic blistering disease with predilection for mucous membranes and less frequently the skin, and with a tendency to scarring. It is sometimes called ocular pemphigoid because of conjunctival mucous membrane involvement.
Ichthyosiform Erythroderma, Congenital
Designation for several severe forms of ichthyosis, present at birth, that are characterized by hyperkeratotic scaling. Infants may be born encased in a collodion membrane which begins shedding within 24 hours. This is followed in about two weeks by persistent generalized scaling. The forms include bullous (HYPERKERATOSIS, EPIDERMOLYTIC), non-bullous (ICHTHYOSIS, LAMELLAR), wet type, and dry type.
Prednisone
A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
Clinical Trials
Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid
The aim of the study is to assess that it will be possible to control with a single cycle of rituximab patient with bullous pemphigoid.
Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids.
Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and conflict the exclusion crite...
Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid
Bullous pemphigoid (BP) is the most common blistering auto-immune disease of skin with an incidence estimated to 400 new cases per year. Topical corticosteroid therapy is considered the st...
Rituximab in the Treatment of Patients With Bullous Pemphigoid
This study will determine the safety of treatment of bullous pemphigoid in patients resistant to therapy with systemic corticosteroids, with rituximab plus systemic corticosteroids.
Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid
To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid.
PubMed Articles
Coexistence of psoriasis and bullous pemphigoid: remission with low-dose methotrexate.
The coexistence of psoriasis vulgaris and bullous pemphigoid is rare. Here, we report a 90-year-old patient with a 20-year history of psoriasis. She developed vesicles and bullae suddenly and was diag...
Trauma-Associated Juvenile Bullous Pemphigoid in a Teenager with Crohn's Disease.
Bullous pemphigoid is an autoimmune blistering disorder rarely seen in the pediatric population. We report a case of trauma-associated bullous pemphigoid presenting in a 15-year-old boy with Crohn...
Bullous Pemphigoid: A Case Series with Emphasis on Long-Term Remission off Therapy.
Abstract Background: Bullous Pemphigoid (BP) is the most common blistering autoimmune skin disease. Combination methotrexate (MTX) and prednisone therapy is an effective short-term treatment for BP....
Pemphigoid diseases: Pathogenesis, diagnosis, and treatment.
Pemphigoid diseases (including bullous pemphigoid, mucous membrane pemphigoid, pemphigoid gestationis, linear IgA dermatosis, lichen planus pemphigoides, and anti-p200 pemphigoid) are a subgroup of au...
Role of IgE in bullous pemphigoid: a review and rationale for IgE directed therapies.
Bullous pemphigoid (BP) is an autoimmune blistering disorder that is characterized by elevated total serum IgE and both IgG and IgE class autoantibodies directed against the hemidesmosomal proteins BP...
