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

• Sponsor: Nihon Pharmaceutical Co., Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01408550
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Aug 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The score using Pemphigus Disease Area Index (PDAI) [15 days]

Secondary Outcome Measures

1. Pemphigoid Activity Score [8 weeks]

2. anti-BP180 antibody titers [8 weeks]

3. Oral Steroid dose [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Osaka		Japan

Sponsors and Collaborators

• Nihon Pharmaceutical Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01408550
• Other Study ID Numbers: NPB-01-06/C-01
• First Posted: Aug 3, 2011
• Last Update Posted: Oct 16, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by , ,: IVIG in pemphigoid; Patients with bullous pemphigoid unresponsive to corticosteroids
• Additional relevant MeSH terms: Pemphigoid, Bullous

Study Results

No Results Posted as of Oct 16, 2013