Bullous PemphigoidPhase 3NCT01408550
Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids
A Phase 3 study testing NPB-01 in people with Bullous Pemphigoid, run by Nihon Pharmaceutical Co., Ltd at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- NPB-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2011to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with corticosteroids over 0.4mg/kg/day(Prednisolone) at informed consent.
- Patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent.
- Patients who the score using Pemphigus Disease Area Index(PDAI) is score10 and more before study medication received.
- Patients who the score using Pemphigus Disease Area Index(PDAI) is not improve before study medication received.
- Patients with twenty years old at informed consent.
- Patients with hospitalization during five consecutive days of study medication and seven consecutive days after administration of study medication .
Who cannot join
- Patients treated with plasmapheresis at 28 days before informed consent.
- Patients treated with corticosteroids pulse therapy(methylprednisolone over 0.5g/day) at 14 days before informed consent.
- Patients treated with intravenous immunoglobulin at 56 days before informed consent.
- Patients who receive or adjust in increments immunosuppressants at 14 days before informed consent.
- Patients with malignancy or a history of this disease.
- Patients with history of shock for NPB-01.
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- Patients with history of hypersensitivity for NPB-01.
- Patients with IgA deficiency.
- Patients with impaired liver function.
- Patients with impaired renal function.
- Patients with cerebro- or cardiovascular disorders.
- Patients with high risk of thromboembolism.
- Patients with hemolytic/hemorrhagic anemia.
- Patients with decreased cardiac function.
- Patients with decreased platelet.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Bullous Pemphigoid
- Being tested
- NPB-01, Placebo
- Keywords
- IVIG in pemphigoid, Patients with bullous pemphigoid unresponsive to corticosteroids
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPB-01Drug
Intravenous immunoglobulin
PlaceboDrug
Physiological saline
| Study group | Role | What they receive |
|---|---|---|
| NPB-01 | Active comparator | Active Comparator: 1 Intravenous immunoglobulin Receives: Drug: NPB-01 |
| Placebo | Placebo comparator | Placebo Comparator: 2 Physiological saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score using Pemphigus Disease Area Index (PDAI)
Measured: 15 days
Secondary outcomes (3)
Pemphigoid Activity Score
Measured: 8 weeks
anti-BP180 antibody titers
Measured: 8 weeks
Oral Steroid dose
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nihon Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408550
- Sponsor's protocol ID
- NPB-01-06/C-01
- Status last verified
- Oct 2013
- First submitted
- 27 Jul 2011
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01408550
- Acronym / sponsor ID
- NPB-01-06/C-01
- Conditions
- Bullous Pemphigoid
- Keywords
- IVIG in pemphigoid, Patients with bullous pemphigoid unresponsive to corticosteroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Nihon Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPB-01 | Active comparator | Drug: NPB-01Active Comparator: 1 Intravenous immunoglobulin |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator: 2 Physiological saline |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with corticosteroids over 0.4mg/kg/day(Prednisolone) at informed consent.
- Patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent.
- Patients who the score using Pemphigus Disease Area Index(PDAI) is score10 and more before study medication received.
- Patients who the score using Pemphigus Disease Area Index(PDAI) is not improve before study medication received.
- Patients with twenty years old at informed consent.
Key exclusion criteria (15 listed)
- Patients treated with plasmapheresis at 28 days before informed consent.
- Patients treated with corticosteroids pulse therapy(methylprednisolone over 0.5g/day) at 14 days before informed consent.
- Patients treated with intravenous immunoglobulin at 56 days before informed consent.
- Patients who receive or adjust in increments immunosuppressants at 14 days before informed consent.
- Patients with malignancy or a history of this disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPB-01Intravenous immunoglobulin | Drug | NPB-01 |
| PlaceboPhysiological saline | Drug | Placebo |
Primary outcome
The score using Pemphigus Disease Area Index (PDAI)
Time frame: 15 days
3 secondary outcomes
Pemphigoid Activity Score
Time frame: 8 weeks
anti-BP180 antibody titers
Time frame: 8 weeks
Oral Steroid dose
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NPB-01 in people with Bullous Pemphigoid, run by Nihon Pharmaceutical Co., Ltd at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score using Pemphigus Disease Area Index (PDAI) (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.