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

Primary Purpose

Bullous Pemphigoid

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

NPB-01

Placebo

About this trial

This is an interventional treatment trial for Bullous Pemphigoid focused on measuring IVIG in pemphigoid, Patients with bullous pemphigoid unresponsive to corticosteroids

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with corticosteroids over 0.4mg/kg/day(Prednisolone) at informed consent.
Patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent.
Patients who the score using Pemphigus Disease Area Index(PDAI) is score10 and more before study medication received.
Patients who the score using Pemphigus Disease Area Index(PDAI) is not improve before study medication received.
Patients with twenty years old at informed consent.
Patients with hospitalization during five consecutive days of study medication and seven consecutive days after administration of study medication .

Exclusion Criteria:

Patients treated with plasmapheresis at 28 days before informed consent.
Patients treated with corticosteroids pulse therapy(methylprednisolone over 0.5g/day) at 14 days before informed consent.
Patients treated with intravenous immunoglobulin at 56 days before informed consent.
Patients who receive or adjust in increments immunosuppressants at 14 days before informed consent.
Patients with malignancy or a history of this disease.
Patients with history of shock for NPB-01.
Patients with history of hypersensitivity for NPB-01.
Patients with IgA deficiency.
Patients with impaired liver function.
Patients with impaired renal function.
Patients with cerebro- or cardiovascular disorders.
Patients with high risk of thromboembolism.
Patients with hemolytic/hemorrhagic anemia.
Patients with decreased cardiac function.
Patients with decreased platelet.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NPB-01

Placebo

Arm Description

Active Comparator: 1 Intravenous immunoglobulin

Placebo Comparator: 2 Physiological saline

Outcomes

Primary Outcome Measures

The score using Pemphigus Disease Area Index (PDAI)

Secondary Outcome Measures

Pemphigoid Activity Score

anti-BP180 antibody titers

Oral Steroid dose

Full Information

NCT ID

NCT01408550

First Posted

July 27, 2011

Last Updated

October 15, 2013

Sponsor

Nihon Pharmaceutical Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01408550

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nihon Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bullous Pemphigoid

Keywords

IVIG in pemphigoid, Patients with bullous pemphigoid unresponsive to corticosteroids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NPB-01

Arm Type

Active Comparator

Arm Description

Active Comparator: 1 Intravenous immunoglobulin

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Comparator: 2 Physiological saline

Intervention Type

Drug

Intervention Name(s)

NPB-01

Intervention Description

Intravenous immunoglobulin

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Physiological saline

Primary Outcome Measure Information:

Title

The score using Pemphigus Disease Area Index (PDAI)

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Pemphigoid Activity Score

Time Frame

8 weeks

Title

anti-BP180 antibody titers

Time Frame

8 weeks

Title

Oral Steroid dose

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with corticosteroids over 0.4mg/kg/day(Prednisolone) at informed consent. Patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent. Patients who the score using Pemphigus Disease Area Index(PDAI) is score10 and more before study medication received. Patients who the score using Pemphigus Disease Area Index(PDAI) is not improve before study medication received. Patients with twenty years old at informed consent. Patients with hospitalization during five consecutive days of study medication and seven consecutive days after administration of study medication . Exclusion Criteria: Patients treated with plasmapheresis at 28 days before informed consent. Patients treated with corticosteroids pulse therapy(methylprednisolone over 0.5g/day) at 14 days before informed consent. Patients treated with intravenous immunoglobulin at 56 days before informed consent. Patients who receive or adjust in increments immunosuppressants at 14 days before informed consent. Patients with malignancy or a history of this disease. Patients with history of shock for NPB-01. Patients with history of hypersensitivity for NPB-01. Patients with IgA deficiency. Patients with impaired liver function. Patients with impaired renal function. Patients with cerebro- or cardiovascular disorders. Patients with high risk of thromboembolism. Patients with hemolytic/hemorrhagic anemia. Patients with decreased cardiac function. Patients with decreased platelet.

Facility Information:

City

Osaka

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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