Bullous Pemphigoid Clinical Trial
Official title:
NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Bullous Pemphigoid Unresponsive to Corticosteroids: Randomized, Double-Blind, Placebo Control,Parallel Assignment Study(Phase III)
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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