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

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