UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060684 |
|---|---|
| Receipt number | R000069381 |
| Scientific Title | Exploratory Study on Cutaneous Immune Cell Profiling in Japanese Patients with Moderate-to-Severe Atopic Dermatitis Treated with Biologics |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/13 15:19:13 |
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Basic information
Public title
Exploratory Study on Cutaneous Immune Cell Profiling in Japanese Patients with Moderate-to-Severe Atopic Dermatitis Treated with Biologics
Acronym
INSPIRE-AD
Scientific Title
Exploratory Study on Cutaneous Immune Cell Profiling in Japanese Patients with Moderate-to-Severe Atopic Dermatitis Treated with Biologics
Scientific Title:Acronym
INSPIRE-AD
Region
| Japan |
Condition
Condition
Atopic Dermatitis
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze cutaneous immune cell profile before and after treatment with approved biologics in Japanese atopic dermatitis patients.
Basic objectives2
Others
Basic objectives -Others
Change in immune cell profiles in lesional skin before and after treatment with biologics.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in immune cell profiles in lesional skin before and after treatment with biologics.
Key secondary outcomes
Differences in immune cell profiles in lesional skin between patients who achieve remission and those who do not.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Skin biopsy
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
<Patients with Atopic Dermatitis (AD)>
1. Adult patients (>=18 years of age at the time of informed consent) with moderate-to-severe AD
2. Patients who are eligible for treatment with biologics for AD in accordance with the guidelines for the proper use of biologics and who are either:
- scheduled to receive biologic therapy for the first time (target agents: dupilumab, tralokinumab, lebrikizumab), or
- within 30 weeks (24 weeks + 6 weeks) after initiation of biologic therapy.
3. Patients who are able to provide skin biopsy specimens collected prior to initiation of biologic therapy.
<Healthy Adults>
Individuals aged >=18 years at the time of informed consent.
Key exclusion criteria
<Patients with Atopic Dermatitis (AD)>
Patients who have received, or are scheduled to receive, any of the following treatments within 4 weeks prior to the skin biopsy conducted before initiation of biologic therapy:
(1) Systemic corticosteroids.
(2) Systemic administration of cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, or other immunosuppressive agents.
(3) Oral administration of Janus kinase (JAK) inhibitors.
(4) Phototherapy.
<Healthy Adults>
1. Individuals who are prescribed medications for dermatitis (including topical therapies) or anti-allergic medications at the time of enrollment.
2. Individuals who have been diagnosed with any of the following diseases and are receiving treatment (including topical therapies) for the respective condition at the time of enrollment:
bronchial asthma, allergic conjunctivitis, depression, anxiety disorders, sleep disorders, obstructive sleep apnea syndrome, schizophrenia, dyslipidemia, atherosclerosis, diabetes mellitus, hypertension, coronary artery disease, psoriatic arthritis, Graves' disease, Hashimoto's thyroiditis, chronic obstructive pulmonary disease, end-stage renal disease, chronic kidney disease, Crohn's disease, ulcerative colitis, celiac disease, systemic lupus erythematosus, rheumatoid arthritis
Individuals with concomitant serious infections.
3. Individuals with active tuberculosis.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Saki |
Organization
Kyowa Kirin Co., Ltd.
Division name
Medical Affairs
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
hqmarinkensuit.sh@kyowakirin.com
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Saki |
Organization
Kyowa Kirin Co., Ltd.
Division name
Medical Affairs
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
Homepage URL
hqmarinkensuit.sh@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
Non-Profit Organization MINS
Address
5-20-9-401, Mita, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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 | 03 | 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
| 2025 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Change in cutaneous immune cell profile before and after treatment with approved biologics in Japanese atopic dermatitis patients
Management information
Registered date
| 2026 | Year | 02 | Month | 16 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069381
