Efficacy and Safety of Omalizumab in Bullous Pemphigoid

Conditions

• Bullous Pemphigoid

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — DRUG
  Patients will be treated with 150-375 milligrams of Omalizumab (Xolair), based on their baseline weight and serum Immunoglobulin E levels. Omalizumab will be administered subcutaneously on Day 1, and on Week 2, 4, 6, 8, 10, 12 and 14 treatment.
• prednisone — DRUG
  Prednisone, to a maximum dose of 0.5 mg/kg/day.

Study Details

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.

Key Dates

First listed

May 10, 2007

Start date

Aug 31, 2007

Status verified

Sep 2012

Primary completion

Dec 31, 2010

Completion

Dec 31, 2010

Study Design

Enrollment

2 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Omalizumab
  Patients will be treated with 150-375 milligrams of Omalizumab (Xolair), based on their baseline weight and serum Immunoglobulin E levels. Omalizumab will be administered subcutaneously on Day 1, and on Week 2, 4, 6, 8, 10, 12 and 14 treatment.
• Active Comparator: Prednisone
  The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.

Primary Outcome Measure

Median Time From First Dose of Omalizumab Treatment to Cessation of New Blisters. [ Time Frame: Up to 24 weeks ]

Locations (1)

Find similar trials in Iowa City, IA

Related Studies

• Autoimmune Blistering Diseases Study
  Recruiting · University of Pennsylvania · Philadelphia, Pennsylvania