UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056931 |
|---|---|
| Receipt number | R000065023 |
| Scientific Title | Retrospective Observational Study of Atopic Dermatitis Patient Treated with Tralokinumab in Japanese Real-world Practice |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2026/08/25 13:48:17 |
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Basic information
Public title
Retrospective Observational Study of Atopic Dermatitis Patient Treated with Tralokinumab in Japanese Real-world Practice
Acronym
A retrospective analysis of tralokinumab
Scientific Title
Retrospective Observational Study of Atopic Dermatitis Patient Treated with Tralokinumab in Japanese Real-world Practice
Scientific Title:Acronym
A retrospective analysis of tralokinumab
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to gather information for the appropriate use of tralokinumab, to understand the actual treatment practices, including treatment response and concomitant medications, in Japanese real-world clinical settings for AD patients treated with tralokinumab. 1 In addition to treatment content after 16 weeks of administration, the study also aims to explore whether there are any characteristic features in usefulness depending on patient background, combined therapies, etc
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Distribution of IGA scores from the start of Tralokinumab administration at16 weeks
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated with tralokinumab for the treatment of AD which is inadequately responsive to conventional therapies
Patients with medical records of at least 16 weeks or more after starting tralokinumab treatment
Key exclusion criteria
Cases where tralokinumab was clearly used outside its approved indications.
Patients with prior experience participating in clinical trials for tralokinumab.
Patients who have refused to participate in this study (i.e., refused the use of their medical records).
The opportunity for research subjects to refuse the use of their medical records in this study (opt-out) will be ensured.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kabashima |
Organization
Professor, Department of Dermatology, Kyoto University
Nonprofit 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
EBC&M LLC
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
Nonprofit Organization Skin Health Research Organization
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
| 2025 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.iyaku.info/archive/up_img/1783650749-071715.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.iyaku.info/archive/up_img/1783650749-071715.pdf
Number of participants that the trial has enrolled
127
Results
This study included 127 patients with atopic dermatitis who initiated tralokinumab between 2023 and 2025. IGA 0/1 response rates were 35.8% at Week 16 and 47.5% at Week 24. Treatment persistence rates were 94.5%, 90.6%, 85.6%, and 70.7% at Weeks 16, 24, 32, and 48, respectively. Adverse drug reactions occurred in 13 patients (17 events), all mild to moderate. Tralokinumab showed favorable effectiveness, tolerability, and treatment persistence in real-world practice.
Results date posted
| 2026 | Year | 08 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 127 patients were enrolled, and the mean age (standard deviation) was 40.8 years (17.1). Among the 127 patients, 71 were male and 56 were female, and the mean IGA score at treatment initiation was 3.2 (0.6). Most patients had moderate to severe atopic dermatitis with an IGA score of 3 or higher. Prior treatment before initiation of tralokinumab most commonly consisted of conventional therapies centered on topical treatment that had been insufficiently effective in 95 patients, while 32 patients had switched from other systemic therapies.
Participant flow
All 127 enrolled patients were included in the safety analysis and treatment persistence analyses. By Week 16, 5 patients had switched to another therapy, and 122 patients continued treatment. At Week 24, 116 patients remained on treatment. Seven patients who switched to another therapy by Week 24 were excluded, resulting in an effectiveness analysis population of 120 patients.
Adverse events
Adverse drug reactions were reported in 13 patients (17 events). All events were mild to moderate in severity, and no serious adverse reactions were observed. Treatment discontinuation due to adverse drug reactions occurred in three patients.
Outcome measures
Distribution of Investigator's Global Assessment (IGA) scores at Week 16 after initiation of tralokinumab treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study(no invasive)
Management information
Registered date
| 2025 | Year | 02 | Month | 04 | Day |
Last modified on
| 2026 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065023
