Efficacy and Safety of Omalizumab in Bullous Pemphigoid

• 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
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Janet A Fairley, MD
• 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 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]

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]

Secondary Outcome(s)

Decrease in Eosinophil Levels Following Treatment With Omalizumab. [Time Frame: Baseline, 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]

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]

Secondary ID(s)

100569

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech, Inc.

Results

• Results available: Yes
• Date Posted: 16/10/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00472030