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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPB-01 | Active Comparator | Active Comparator: 1 Intravenous immunoglobulin |
|
| Placebo | Placebo Comparator | Placebo Comparator: 2 Physiological saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPB-01 | Drug | Intravenous immunoglobulin |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The score using Pemphigus Disease Area Index (PDAI) | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pemphigoid Activity Score | 8 weeks | |
| anti-BP180 antibody titers | 8 weeks | |
| Oral Steroid dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan |
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| ID | Term |
|---|---|
| D010391 | Pemphigoid, Bullous |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
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| Drug |
Physiological saline |
|
| 8 weeks |
| D007154 | Immune System Diseases |