Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids
Information source: Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bullous Pemphigoid
Intervention: NPB-01 (Drug); Placebo (Drug)
Phase: Phase 3
Sponsored by: Nihon Pharmaceutical Co., Ltd
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
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.
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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: The score using Pemphigus Disease Area Index (PDAI)
Pemphigoid Activity Score
anti-BP180 antibody titers
Oral Steroid dose
Minimum age: 20 Years.
Maximum age: N/A.
1. Patients with corticosteroids over 0. 4mg/kg/day(Prednisolone) at informed consent.
2. Patients with continued treatment for bullous pemphigoid without add or change the
treatment after informed consent.
3. Patients who the score using Pemphigus Disease Area Index(PDAI) is score10 and more
before study medication received.
4. Patients who the score using Pemphigus Disease Area Index(PDAI) is not improve before
study medication received.
5. Patients with twenty years old at informed consent.
6. Patients with hospitalization during five consecutive days of study medication and
seven consecutive days after administration of study medication .
1. Patients treated with plasmapheresis at 28 days before informed consent.
2. Patients treated with corticosteroids pulse therapy(methylprednisolone over 0. 5g/day)
at 14 days before informed consent.
3. Patients treated with intravenous immunoglobulin at 56 days before informed consent.
4. Patients who receive or adjust in increments immunosuppressants at 14 days before
5. Patients with malignancy or a history of this disease.
6. Patients with history of shock for NPB-01.
7. Patients with history of hypersensitivity for NPB-01.
8. Patients with IgA deficiency.
9. Patients with impaired liver function.
10. Patients with impaired renal function.
11. Patients with cerebro- or cardiovascular disorders.
12. Patients with high risk of thromboembolism.
13. Patients with hemolytic/hemorrhagic anemia.
14. Patients with decreased cardiac function.
15. Patients with decreased platelet.
Locations and Contacts
Starting date: August 2011
Last updated: October 15, 2013