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Sponsors and Collaborators: |
University of Iowa Genentech |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00472030 |
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.
Condition | Intervention | Phase |
---|---|---|
Bullous Pemphigoid |
Drug: omalizumab Drug: prednisone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Case Series on the Effects of Xolair (Omalizumab) in Bullous Pemphigoid |
Estimated Enrollment: | 12 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Omalizumab treatment.
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Drug: omalizumab
Subcutaneous administration of omalizumab, dose dependent on weight and circulating levels of IgE. Omalizumab will be administered every 4 weeks for 12 weeks. Additional injections will be given on weeks 2,6,10 and 14 if required based on weight and IgE levels.
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2: Active Comparator
The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
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Drug: prednisone
Prednisone, to a maximum dose of 0.5 mg/kg/day.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Debra S Brandt, BSN | 319-353-6439 | debra-brandt@uiowa.edu |
Contact: Janet A Fairley, MD | 319-356-3609 | janet-fairley@uiowa.edu |
United States, Iowa | |
University of Iowa, Department of Dermatology | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Debra S Brandt, BSN 319-353-6439 debra-brandt@uiowa.edu | |
Contact: Janet A Fairley, MD 319-356-3609 janet-fairley@uiowa.edu | |
Principal Investigator: Janet A Fairley, MD |
Principal Investigator: | Janet A Fairley, MD | University of Iowa |
Responsible Party: | University of Iowa ( Janet A. Fairley, M.D. ) |
Study ID Numbers: | 100569 |
Study First Received: | May 8, 2007 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00472030 History of Changes |
Health Authority: | United States: Food and Drug Administration |
bullous pemphigoid omalizumab xolair |
IgE autoimmunity skin disease |
Anti-Inflammatory Agents Prednisone Autoimmune Diseases Skin Diseases Skin Diseases, Vesiculobullous Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Anti-Asthmatic Agents Anti-Allergic Agents Glucocorticoids Hormones Pemphigoid, Bullous Bullous Pemphigoid Omalizumab |
Anti-Inflammatory Agents Respiratory System Agents Prednisone Autoimmune Diseases Skin Diseases, Vesiculobullous Skin Diseases Immune System Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Anti-Allergic Agents Glucocorticoids Hormones Pharmacologic Actions Pemphigoid, Bullous Therapeutic Uses Omalizumab |