Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060684) titled 'Exploratory Study on Cutaneous Immune Cell Profiling in Japanese Patients with Moderate-to-Severe Atopic Dermatitis Treated with Biologics' on March 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Kyowa Kirin Co., Ltd.

Condition: Condition - Atopic Dermatitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To analyze cutaneous immune cell profile before and after treatment with approved biologics in Japanese atopic dermatitis patients. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Skin biopsy

Eligibility: Age-lower limit - 18 years-old

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.

Individuals aged >=18 years at the time of informed consent. Key exclusion criteria - 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.



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 Size - 35

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069381

Disclaimer: Curated by HT Syndication.