Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids.

Summary

Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and conflict the exclusion criteria will receive NPB-01(intravenous immunoglobulin) 400mg/kg/day for five consecutive days or Placebo(physiological saline). Subsequently, efficacy of NPB-01 for therapy of bullous pemphigoid will evaluate using pemphigoid activity score involving skin lesion area and Number of new blisters. As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by 57 days after the start of the study treatment.

Timeline

Start

2008-11

Primary completion

2010-10

Completion

2010-10

Drugs

Indications