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)

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.

Study Overview

• Status: Completed
• Conditions: Bullous Pemphigoid
• Intervention / Treatment: Drug: NPB-01; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NPB-01; Active Comparator: 1 Intravenous immunoglobulin	Drug: NPB-01; Intravenous immunoglobulin
Placebo Comparator: Placebo; Placebo Comparator: 2 Physiological saline	Drug: Placebo; Physiological saline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nihon Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 27, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (Estimate): August 3, 2011

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 15, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: IVIG in pemphigoid; Patients with bullous pemphigoid unresponsive to corticosteroids
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Skin Diseases, Vesiculobullous; Pemphigoid, Bullous
• Other Study ID Numbers: NPB-01-06/C-01