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

NCT00809822 | Completed Phase 2

• 1 other identifier: NPB-01-06/E-01
• Study Type: interventional
• Target: 20
• 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 conflict 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 evaluate using 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)

• Skin lesion area (%), Number of new blisters/day, Pemphigoid Activity Score, Pemphigus Disease Area Index(PDAI), anti-BP180 and -BP230 antibody titers, Steroid dose, Time to escape from the protocol and its ratio

  57 days

Study Arms (2)

1

ACTIVE COMPARATOR

Intravenous immunoglobulin

Drug: NPB-01

2

PLACEBO COMPARATOR

Physiological saline

Drug: Placebo

Interventions

NPB-01 DRUG

Intravenous immunoglobulin

1

Placebo DRUG

Physiological saline

2

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 20mg/day(Prednisolone) at informed consent.
• Patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent.
• Patients who pemphigoid activity score is score1 and more before study medication received.
• Patients who symptom 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.

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 17, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 25, 2010

Record last verified: 2010-10

Locations

JP (1)