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

NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Bullous Pemphigoid Unresponsive to Corticosteroids: Randomized, Double-Blind, Placebo Control,Parallel Assignment Study(Phase III)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01408550

Enrollment

Registered

2011-08-03

Start date

2011-08-31

Completion date

2013-09-30

Last updated

2013-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bullous Pemphigoid

Keywords

IVIG in pemphigoid, Patients with bullous pemphigoid unresponsive to corticosteroids

Brief 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.

Interventions

DRUGNPB-01

Intravenous immunoglobulin

DRUGPlacebo

Physiological saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

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 .

Exclusion criteria

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 informed consent. 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.

Design outcomes

Primary

Measure	Time frame
The score using Pemphigus Disease Area Index (PDAI)	15 days

Secondary

Measure	Time frame
Pemphigoid Activity Score	8 weeks
anti-BP180 antibody titers	8 weeks
Oral Steroid dose	8 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026