UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056740 |
|---|---|
| Receipt number | R000064838 |
| Scientific Title | Comparative Analysis of Psoriasis Patients in Japan and the US Based on the ESPRIT Study |
| Date of disclosure of the study information | 2025/01/20 |
| Last modified on | 2025/01/16 13:36:58 |
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Basic information
Public title
Comparative Analysis of Psoriasis Patients in Japan and the US Based on the ESPRIT Study
Acronym
Additional analysis of the ESPRIT study
Scientific Title
Comparative Analysis of Psoriasis Patients in Japan and the US Based on the ESPRIT Study
Scientific Title:Acronym
Additional analysis of the ESPRIT study
Region
| Japan |
Condition
Condition
Plaque psoriasis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare Japanese and American patients with psoriasis.
Basic objectives2
Others
Basic objectives -Others
Gene comparison between races
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interracial comparison of gene expression levels in non-lesional and lesional skin at baseline
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<ESPRIT study>
1) Patients who have given written informed consent to participate
2) Patients diagnosed with plaque psoriasis prior to enrollment
3) Patients who are aged 18 years or older at the time of informed consent
4) Patients with a PASI score >10 or BSA >10%
5) Patients who met the requirements of the package insert (LUMICEF Subcutaneous Injection 210mg Syringe)
<PAUSE study>
1) A diagnosis of plaque psoriasis for at least 6 months
2) Baseline Psoriasis Area and Severity Index (PASI) score >= 12
3) >= 10% body surface area psoriasis involvement
4) Willingness to forgo other available psoriasis therapies, live vaccines, and pregnancy during the trial
5) Ability and willingness to provide informed consent and comply with study requirements
Key exclusion criteria
<ESPRIT study>
1) Patients with pustular psoriasis
2) Patients with psoriatic erythroderma
3) Patients who have received brodalumab
4) Patients who took immunosuppressants (steroids [oral, topical*2 (including compound drug)], cyclosporine, and methotrexate) within 4 weeks before Day 1*1
*1 Day 1 is the day of the first dose of brodalumab in this study.
*2 Topical steroid (including compound drug) is allowed to be used in areas other than the planned biopsy site.
5) Patients with serious infections
6) Patients with active tuberculosis
7) Patients with history of hypersensitivity to brodalumab
<PAUSE study>
Harris KM, Smilek DE, Byron M, Lim N, Barry WT, McNamara J, Garcet S, Konrad RJ, Stengelin M, Bathala P, Korman NJ, Feldman SR, Boh EE, Barber K, Laumann AE, Helfrich YR, Krueger GG, Sofen H, Bissonnette R, Krueger JG. Effect of Costimulatory Blockade With Abatacept After Ustekinumab Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: The PAUSE Randomized Clinical Trial. JAMA Dermatol. 2021 Nov 1;157(11):1306-1315. doi: 10.1001/jamadermatol.2021.3492.
Target sample size
148
Research contact person
Name of lead principal investigator
| 1st name | Akimichi |
| Middle name | |
| Last name | Morita |
Organization
Nagoya city university
Division name
Department of Geriatric and Environmental Dermatology
Zip code
467-8601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601,JAPAN
TEL
052-851-5511
akimichi_morita@mac.com
Public contact
Name of contact person
| 1st name | Yasumasa |
| Middle name | |
| Last name | Kanai |
Organization
Kyowa Kirin Co., Ltd.
Division name
Medical Affairs Department
Zip code
100-0004
Address
Otemachi Financial City Grand Cube, 1-9-2 Otemachi, Chiyoda-ku, Tokyo 100-0004,JAPAN
TEL
03-5205-7200
Homepage URL
ma.immunology_2g.xw@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
Nagoya City University Institutional Review Board
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601,JAPAN
Tel
052-858-7215
clinical_research@med.nagoya-cu.ac.jp
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
| 2025 | Year | 01 | Month | 20 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
ESPRIT study (jRCTs041190114)
PAUSE study (NCT01999868)
Management information
Registered date
| 2025 | Year | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064838
