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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00472030
Date of registration: 08/05/2007
Prospective Registration: Yes
Primary sponsor: University of Iowa
Public title: Efficacy and Safety of Omalizumab in Bullous Pemphigoid
Scientific title: An Open Label Case Series on the Effects of Xolair (Omalizumab) in Bullous Pemphigoid
Date of first enrolment: August 2007
Target sample size: 2
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00472030
Study type:  Interventional
Study design:   
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Janet A Fairley, MD
Address: 
Telephone:
Email:
Affiliation:  University of Iowa
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must have the clinical and histological findings consistent with bullous
pemphigoid. Clinically this is defined as urticarial plaques and/or vesicles and
bullae. Histologically patients must show characteristic eosinophilic spongiosis
and/or subepidermal separation of the skin consistent with BP.

- Patients must have either a positive direct (IgG and/or C3 at the BMZ) or indirect
(IgG on the roof of salt-split skin) immunofluorescence microscopy features of
pemphigoid.

- Patients of both sexes, all races and ethnic backgrounds that are 18 years of age or
older will be eligible to participate in this study.

- Patients much have more than 5% total body surface involved, since patients with less
extensive disease are often treated with topical measures only.

Exclusion Criteria:

- Women of childbearing potential not using the contraception method(s) specified during
this study. Women of childbearing potential must use proven birth control methods
(such as - abstinence, birth control pills, intrauterine device, barrier method
combined with gel or foam with spermicide, tubal ligation, or a partner who has had a
vasectomy).

- Women who are pregnant or breastfeeding.

- Patients under the age of 18.

- Patients unable to give informed consent.

- Known sensitivity to study drug(s) or class of study drug(s).

- Patients with severe medical condition(s) that in the view of the investigator
prohibits participation in the study.

- Any cancer other than non-melanoma skin cancer in the past 5 years.

- All non-melanoma skin cancers must have been adequately treated at entrance to the
study.

- Use of any other investigational agent in the last 30 days.

- Treatment with prednisone in the past 2 weeks.

- Weight or serum IgE levels that place the patient outside standard dosing guidelines
for Xolair.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Bullous Pemphigoid
Intervention(s)
Drug: Omalizumab
Drug: prednisone
Primary Outcome(s)
Median Increase in Prednisone Dosage Measured at Week 4, 8 and 24 in Patients Treated With Omalizumab and in Patients Receiving Standard Therapy. [Time Frame: Week 4, Week 8 and Week 24]
Median Time From First Dose of Omalizumab Treatment to Cessation of New Blisters. [Time Frame: Up to 24 weeks]
Percent Decrease in the Total Body Surface Area Affected By Active Bullous Pemphigoid Skin Disease From Day 0 to Week 24. [Time Frame: Up to 24 weeks]
Secondary Outcome(s)
Change in Histamine Release Assay Following Treatment With Omalizumab. [Time Frame: Up to 24 weeks]
Decrease in Anti-BP180 IgG (Immunoglobulin G Anti-Bullous Pemphigoid 180 Antibody) Following Treatment With Omalizumab. [Time Frame: Up to 24 weeks]
Decrease in Anti-BP230 Antibody IgG (Anti-bullous Pemphigoid 230 Antibody Immunoglobulin G) At Baseline and Week 16 [Time Frame: Up to 24 weeks]
Decrease in Eosinophil Levels Following Treatment With Omalizumab. [Time Frame: Baseline, 24 weeks.]
Secondary ID(s)
100569
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Genentech, Inc.
Ethics review
Results
Results available: Yes
Date Posted: 16/10/2012
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00472030
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