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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01408550
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : October 16, 2013
Information provided by:
Nihon Pharmaceutical Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Bullous Pemphigoid Drug: NPB-01 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus Steroids

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

Primary Outcome Measures :
  1. The score using Pemphigus Disease Area Index (PDAI) [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Pemphigoid Activity Score [ Time Frame: 8 weeks ]
  2. anti-BP180 antibody titers [ Time Frame: 8 weeks ]
  3. Oral Steroid dose [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01408550

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Osaka, Japan
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd

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Responsible Party: Nihon Pharmaceutical Co., Ltd, Clinical Development Department Identifier: NCT01408550     History of Changes
Other Study ID Numbers: NPB-01-06/C-01
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Keywords provided by Nihon Pharmaceutical Co., Ltd:
IVIG in pemphigoid
Patients with bullous pemphigoid unresponsive to corticosteroids
Additional relevant MeSH terms:
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Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs