UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044388 |
|---|---|
| Receipt number | R000050703 |
| Scientific Title | Immunological analysis of patients treated with novel therapeutic agents for atopic dermatitis |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2021/06/01 10:30:55 |
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Basic information
Public title
Analysis of patients treated with novel therapeutic agents for atopic dermatitis
Acronym
Analysis of patients treated with novel therapeutic agents for atopic dermatitis
Scientific Title
Immunological analysis of patients treated with novel therapeutic agents for atopic dermatitis
Scientific Title:Acronym
Immunological analysis of patients treated with novel therapeutic agents for atopic dermatitis
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to identify immune-related factors involved in the response to novel therapeutic agents such as biologics and biomarkers that can be used as a reference for treatment selection in the analysis of atopic dermatitis in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Identify surface markers of immunocompetent cells, cytokines, and chemokines that correlate with the severity of skin symptoms and hematological findings before and after treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dupilumab or Baricitinib
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who have been diagnosed with atopic dermatitis and are scheduled to receive a biologic such as dupilumab or a small molecule targeted drug such as baricitinib
Key exclusion criteria
Patients who are receiving or have received systemic steroids or cyclosporine within the past 4 weeks.
Patients who are receiving or have received other biologics.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Otsuka |
Organization
Kindai University Hospital
Division name
Department of Dermatology
Zip code
589-8511
Address
377-2, Ohnohigashi, Osaka Sayama City, Osaka Prefecture
TEL
072-366-0221
otsukaman@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Chisa |
| Middle name | |
| Last name | Nakashima |
Organization
Kindai University Hospital
Division name
Department of Dermatology
Zip code
589-8511
Address
377-2, Ohnohigashi, Osaka Sayama City, Osaka Prefecture
TEL
072-366-0221
Homepage URL
chisa313@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kindai University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Hospital
Address
377-2, Ohnohigashi, Osaka Sayama City, Osaka Prefecture
Tel
072-366-0221
zizen@med.kindai.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
| 2021 | Year | 09 | Month | 01 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 01 | Day |
Last modified on
| 2021 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050703
