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CompletedNCT00809822NPB-01Updated Oct 25, 2010

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

A Phase 2 interventional study of NPB-01 and Placebo in Bullous Pemphigoid, sponsored by Nihon Pharmaceutical Co., Ltd. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2010-10-25.

Sponsored by Nihon Pharmaceutical Co., Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and conflict 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 evaluate using 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.

02

Conditions studied

  • Bullous Pemphigoid

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Keywords

  • IVIG in pemphigoid
  • Patients with bullous pemphigoid unresponsive to corticosteroids
03

In context

Pemphigoid, Bullous

73 studies on the registry are indexed under Pemphigoid, Bullous; 11 are open to participants now.

This study's planned enrollment of 20 is below the median of 29 across 43 interventional studies indexed under Pemphigoid, Bullous.

Browse Pemphigoid, Bullous studies →

Lead sponsor

Nihon Pharmaceutical Co., Ltd is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with corticosteroids over 20mg/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 pemphigoid activity score is score1 and more before study medication received.
  4. Patients who symptom 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.

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    1

    Intravenous immunoglobulin

    Drug: NPB-01

  • Placebo comparator
    2

    Physiological saline

    Drug: Placebo

Interventions

  • DrugNPB-01

    Intravenous immunoglobulin

  • DrugPlacebo

    Physiological saline

06

What researchers measure

Primary outcomes

  1. Skin lesion area (%), Number of new blisters/day, Pemphigoid Activity Score, Pemphigus Disease Area Index(PDAI), anti-BP180 and -BP230 antibody titers, Steroid dose, Time to escape from the protocol and its ratio

    Time frame: 57 days

07

Study locations

1 site
  • Osaka, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00809822
Lead sponsor
Nihon Pharmaceutical Co., Ltd
First posted
Dec 17, 2008
Start date
Nov 2008
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Oct 25, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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