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

NCT01408550 | Completed Phase 3

• 1 other identifier: NPB-01-06/C-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Bullous Pemphigoid

Keywords

IVIG in pemphigoid; Patients with bullous pemphigoid unresponsive to corticosteroids

Outcome Measures

Primary Outcomes (1)

• The score using Pemphigus Disease Area Index (PDAI)

  15 days

Secondary Outcomes (3)

• Pemphigoid Activity Score

  8 weeks

• anti-BP180 antibody titers

  8 weeks

• Oral Steroid dose

  8 weeks

Study Arms (2)

NPB-01

ACTIVE COMPARATOR

Active Comparator: 1 Intravenous immunoglobulin

Drug: NPB-01

Placebo

PLACEBO COMPARATOR

Placebo Comparator: 2 Physiological saline

Drug: Placebo

Interventions

NPB-01 DRUG

Intravenous immunoglobulin

NPB-01

Placebo DRUG

Physiological saline

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nihon Pharmaceutical Co., Ltd: lead

Study Sites (1)

Unknown Facility

Osaka, Japan

Location

MeSH Terms

Conditions

Pemphigoid, Bullous

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: August 3, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

JP (1)