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

Bullous Pemphigoid Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408550
• Other study ID #: NPB-01-06/C-01
• Status: Completed
• Phase: Phase 3
• First received: July 27, 2011
• Last updated: October 15, 2013
• Start date: August 2011
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Nihon Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bullous Pemphigoid
• Pemphigoid, Bullous

Intervention

Drug:
• NPB-01
Intravenous immunoglobulin
• Placebo
Physiological saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nihon Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The score using Pemphigus Disease Area Index (PDAI)		15 days	No
Secondary	Pemphigoid Activity Score		8 weeks	No
Secondary	anti-BP180 antibody titers		8 weeks	No
Secondary	Oral Steroid dose		8 weeks	No