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

This study has been completed.
Sponsor:
Information provided by:
Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01408550
First received: July 27, 2011
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Bullous Pemphigoid
Drug: NPB-01
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Nihon Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • The score using Pemphigus Disease Area Index (PDAI) [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pemphigoid Activity Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • anti-BP180 antibody titers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Oral Steroid dose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: August 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408550

Locations
Japan
Osaka, Japan
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
  More Information

No publications provided

Responsible Party: Nihon Pharmaceutical Co., Ltd, Clinical Development Department
ClinicalTrials.gov Identifier: NCT01408550     History of Changes
Other Study ID Numbers: NPB-01-06/C-01
Study First Received: July 27, 2011
Last Updated: October 15, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Nihon Pharmaceutical Co., Ltd:
IVIG in pemphigoid
Patients with bullous pemphigoid unresponsive to corticosteroids

Additional relevant MeSH terms:
Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014