Phase 4
Completed N=2
Efficacy and Safety of Omalizumab in Bullous Pemphigoid
Source: ClinicalTrials.gov NCT00472030 ↗Enrolled (actual)
2
Serious AEs
50.0%
Results posted
Oct 2012
Primary outcomePrimary: Median Time From First Dose of Omalizumab Treatment to Cessation of New Blisters. — 6 weeks
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time From First Dose of Omalizumab Treatment to Cessation of New Blisters. |
6 | — |
| PRIMARY Percent Decrease in the Total Body Surface Area Affected By Active Bullous Pemphigoid Skin Disease From Day 0 to Week 24. |
22.5 | — |
| PRIMARY Median Increase in Prednisone Dosage Measured at Week 4, 8 and 24 in Patients Treated With Omalizumab and in Patients Receiving Standard Therapy. |
— | — |
| SECONDARY Decrease in Anti-BP180 IgG (Immunoglobulin G Anti-Bullous Pemphigoid 180 Antibody) Following Treatment With Omalizumab. |
92.06 | — |
| SECONDARY Decrease in Eosinophil Levels Following Treatment With Omalizumab. |
2.16 | — |
| SECONDARY Decrease in Anti-BP230 Antibody IgG (Anti-bullous Pemphigoid 230 Antibody Immunoglobulin G) At Baseline and Week 16 |
62.6 | — |
| SECONDARY Change in Histamine Release Assay Following Treatment With Omalizumab. |
— | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00472030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.