UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061150 |
|---|---|
| Receipt number | R000069294 |
| Scientific Title | Atopic Dermatitis - Treatment Response EVALuation and UsEr Satisfaction with Tralokinumab in Standard Clinical Practice in Japan |
| Date of disclosure of the study information | 2026/04/08 |
| Last modified on | 2026/04/03 13:14:43 |
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Basic information
Public title
Atopic Dermatitis - Treatment Response EVALuation and UsEr Satisfaction with Tralokinumab in Standard Clinical Practice in Japan
Acronym
The ADValue Study
Scientific Title
Atopic Dermatitis - Treatment Response EVALuation and UsEr Satisfaction with Tralokinumab in Standard Clinical Practice in Japan
Scientific Title:Acronym
The ADValue Study
Region
| Japan | Europe |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This observational study aims to assess the 52-week real-world effectiveness, safety, and patient-reported outcomes of tralokinumab. Furthermore, the data will be integrated with international studies to characterize the global clinical profile of the treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess disease control after 52 weeks of treatment with tralokinumab based on patient-reported outcome measures.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed AD requiring systemic drug therapy
2. Initiating treatment with tralokinumab according to the treating physician's decision
3. Patients >= 15 years of age
4. Written informed consent obtained prior to enrolment, as follows:
-Patients aged >= years: obtained directly from the patient.
-Patients aged 15 to 17 years: obtained from the legal guardian, and written assent is additionally obtained from the adolescent who is capable of forming an opinion and understanding the information provided.
Key exclusion criteria
1.Enrolment in an interventional study
2.Prior enrolment in this study
3.Prior treatment with tralokinumab (including prior use in a clinical trial).
4.Lack of capability by patient/or caregiver to give informed consent
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kabashima |
Organization
Professor, Department of Dermatology, Kyoto University
Non-Profit Organization Health Institute Research of Skin
Division name
Department of Dermatology
Zip code
101-0047
Address
Fukuda Building 2F, 1-8-9 Uchikanda, Chiyoda-ku, 101-0047,Tokyo, Japan
TEL
03-6435-3868
info@npo-hifu.net
Public contact
Name of contact person
| 1st name | Motohiro |
| Middle name | |
| Last name | Honda |
Organization
EBC&M LLC
Division name
Clinical Division
Zip code
1050011
Address
Shibamatsuobiru 4F, 2-9-1 Shibakoen, Minato-ku, Tokyo-to
TEL
0364353833
Homepage URL
crs5-info@ebc-m.com
Sponsor or person
Institute
LEO Pharma K.K.
Institute
Department
Personal name
Funding Source
Organization
LEO Pharma K.K.
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
Non-Profit Organization Health Institute Research of Skin
Address
Fukuda Bldg. 2F, 1-8-9 Uchikanda, Chiyoda-ku, Tokyo-to
Tel
03-6435-3868
info@npo-hifu.net
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
| 2026 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, prospective observational study with interim analysis
Management information
Registered date
| 2026 | Year | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069294
