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

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.

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Key information

Conditions

Bullous Pemphigoid Autoimmune Diseases Immune System Diseases Pemphigoid, Bullous Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

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.

Treatment and study plan

NPB-01

Drug

Intravenous immunoglobulin

Placebo

Drug

Physiological saline

Primary outcomes

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

Time frame: 57 days

Sponsors and collaborators

Lead sponsor

Nihon Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Acronym: NPB-01

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Dec 17, 2008
Registry last updated: Oct 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed