NPB-01(intravenous immunoglobulin)therapy for patients with pemphigus unresponsive to corticosteroids:Multi-center,Randomized,Double-Blind ,Placebo Control,Parallel Assignment Study to examine dose response and efficacy of NPB-01.(Phase2+3)

NPB-01(intravenous immunoglobulin)therapy for patients with pemphigus unresponsive to corticosteroids:Multi-center,Randomized,Double-Blind ,Placebo Control,Parallel Assignment Study to examine dose response and efficacy of NPB-01.(Phase2+3) - Dose response and efficacy confirmatory study of NPB-01 for patients with pemphigus unresponsive to corticosteroids.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000532

Enrollment

Registered

2006-12-01

Start date

2004-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pemphigus

Interventions

0mg/kg per day for 5 days(placebo) 200mg/kg per day for 5 days 400mg/kg per day for 5 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with pemphigus unresponsive to corticosteroids 2)Patients with corticosteroids over 20mg/day

Exclusion criteria

Exclusion criteria: 1)Patients treated with Plasmapheresis 2)Patients treated with corticosteroids pulse therapy (methylpredonizolone over 0.5g/day) 3)Patients received intravenous immunoglobulin 4) Patients with history of shock for NPB-01 5)Patients with history of Hypersensitivity for NPB-01 6)Patients with IgA deficiency 7)Patients with impaired liver function 8)Patients with impaired renal function 9)Patients with cerebro- or cardiovascular disorders or a history of these disorders 10)Patients with a high risk of thromboembolism

Design outcomes

Primary

Measure	Time frame
Days up to protocol-off	—

Countries

Japan

Contacts

Public Contacttoshikazu okuno

NIHON PHARMACEUTICAL CO.,LTD Clinical Development Department

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026