UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055398 |
|---|---|
| Receipt number | R000063284 |
| Scientific Title | Additional analysis to evaluate activity index of pustulotic arthro-osteitis <A Phase 3, Placebo-Controlled, Double-Blind Comparative Study of KHK4827 With an Open-Label Extension in Subjects With Palmoplantar Pustulosis> |
| Date of disclosure of the study information | 2024/09/03 |
| Last modified on | 2025/09/04 15:41:23 |
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Basic information
Public title
Additional analysis to evaluate activity index of pustulotic arthro-osteitis
<A Phase 3, Placebo-Controlled, Double-Blind Comparative Study of KHK4827 With an Open-Label Extension in Subjects With Palmoplantar Pustulosis>
Acronym
Additional analysis of 4827-009 study on pustulotic arthro-osteitis
Scientific Title
Additional analysis to evaluate activity index of pustulotic arthro-osteitis
<A Phase 3, Placebo-Controlled, Double-Blind Comparative Study of KHK4827 With an Open-Label Extension in Subjects With Palmoplantar Pustulosis>
Scientific Title:Acronym
Additional analysis of 4827-009 study on pustulotic arthro-osteitis
Region
| Japan |
Condition
Condition
Pustulotic arthro-osteitis
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate activity index of pustulotic arthro-osteitis
Basic objectives2
Others
Basic objectives -Others
Disease understanding
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation analysis of MRI Chest Area of edema and major non-imaging indexes
Correlation analysis of MRI Chest Intensity of edema and major non-imaging indexes
Correlation analysis of MRI Sacroiliac joints (SPACC) and major non-imaging indexes
Correlation analysis of MRI spine (SPARCC) and major non-imaging indexes
Key secondary outcomes
Correlation analysis of MRI Chest Area of edema and other non-imaging indexes
Correlation analysis of MRI Chest Intensity of edema and other non-imaging indexes
Correlation analysis of MRI Sacroiliac joints (SPACC) and other non-imaging indexes
Correlation analysis of MRI spine (SPARCC) and other non-imaging indexes
Correlation analysis of other imaging indexes and non-imaging indexes
Correlation analysis of MRI Chest Area of edema and other imaging indexes
Correlation analysis of MRI Chest Intensity of edema and other imaging indexes
Correlation analysis of MRI Sacroiliac joints (SPACC) and other imaging indexes
Correlation analysis of MRI spine (SPARCC) and other imaging indexes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients participating in 4827-009 study who met criteria for pustulotic arthro-osteitis as defined by the study
Key exclusion criteria
Patients who participated in the trial but did not obtain either all the imaging indexes or all the non-imaging indexes.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Nozaki |
Organization
Keio university
Division name
Department of Radiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
nozaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Akiyo |
| Middle name | |
| Last name | Nozaki |
Organization
Kyowa Kirin Co., Ltd.
Division name
Clinical Development Center
Zip code
100-0004
Address
Otemachi Financial City Grand Cube, 1-9-2 Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
Homepage URL
khk4827.ppp-clinical.st@kyowakirin.com
Sponsor or person
Institute
Kyowa Kirin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee / Research Ethical Review Committee of Kyowa Kirin Co., Ltd
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan / 1-9-2, Otemachi, Chiyoda-ku, Tokyo 100-0004, Japan
Tel
03-3353-1211 / 03-5205-7200
med-rinri-jimu@adst.keio.ac.jp / researchethics.fj@kyowakirin.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
A Phase 3, Placebo-Controlled, Double-Blind Comparative Study of KHK4827 With an Open-Label Extension in Subjects With Palmoplantar Pustulosis (NCT04061252)
Management information
Registered date
| 2024 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063284
