Atopic Dermatitis
Conditions
Interventions
Skin biopsy
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in immune cell profiles in lesional skin before and after treatment with biologics. | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in immune cell profiles in lesional skin between patients who achieve remission and those who do not. | — |
Countries
Japan
Contacts
Public ContactMayumi Saki
Kyowa Kirin Co., Ltd. Medical Affairs
Outcome results
None listed