UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058737 |
|---|---|
| Receipt number | R000064442 |
| Scientific Title | Prospective observational study to investigate the relationships between pharmacokinetics and therapeutic efficacy of deucravacitinib in patients with psoriasis. |
| Date of disclosure of the study information | 2025/08/08 |
| Last modified on | 2025/08/08 13:55:27 |
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Basic information
Public title
Prospective observational study to investigate the relationships between pharmacokinetics and therapeutic efficacy of deucravacitinib in patients with psoriasis.
Acronym
Prospective observational study to investigate the relationships between pharmacokinetics and therapeutic efficacy of deucravacitinib in patients with psoriasis.
Scientific Title
Prospective observational study to investigate the relationships between pharmacokinetics and therapeutic efficacy of deucravacitinib in patients with psoriasis.
Scientific Title:Acronym
Prospective observational study to investigate the relationships between pharmacokinetics and therapeutic efficacy of deucravacitinib in patients with psoriasis.
Region
| Japan |
Condition
Condition
psoriasis
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study investigates the relationships between plasma concentration and efficacy of deucravacitinib in patients with psoriasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the impact of deucravacitinib pharmacokinetics on the therapeutic efficacy.
Key secondary outcomes
To explore factors influencing pharmacokinetics of deucravacitinib
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who provided a written consent to participate in the study or whose family provided a written consent to participate in the study
Key exclusion criteria
1. Patients with severe infection
2. Patients with active tuberculosis
3. Patients with severe hepatic impairment (Child-Pugh classification of C)
4. Pregnant, breastfeeding or expecting women
5. Others deemed inappropriate by the attending physician
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tasuku |
| Middle name | |
| Last name | Yokoyama |
Organization
University of Shizuoka
Division name
Laboratory of Clinical Pharmaceutics, School of Pharmaceutical Sciences
Zip code
422-8526
Address
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL
+81-54-264-5857
tyokoyama@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Tasuku |
| Middle name | |
| Last name | Yokoyama |
Organization
University of Shizuoka
Division name
Laboratory of Clinical Pharmaceutics, School of Pharmaceutical Sciences
Zip code
422-8526
Address
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL
+81-54-264-5857
Homepage URL
tyokoyama@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka general hospital
Address
4-27-1, Kitaando, Aoi-ku, Shizuoka, Japan
Tel
054-247-6111
chiken-sougou@shizuoka-pho.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
6-34
Org. issuing International ID_1
University of Shizuoka
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
静岡県立総合病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood samples will be collected on day 28 after the start of treatment with duclarabine for measurement of drug concentration in the blood.
The attending physician will evaluate the efficacy on days 28 and 84.
The relationship between drug concentration in the blood and efficacy will be examined.
Management information
Registered date
| 2025 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064442
