Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national
diagnostic criteria. Patients who meet all inclusion criteria and do not conflict with 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 be evaluated the score using pemphigus disease area index
(PDAI) and 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.