JRCT ID: jRCT1050240261
Registered date:05/02/2025
QSP model building in patients with atopic dermatitis after treatment with nemolizumab
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Atopic dermatitis |
Date of first enrollment | 05/02/2025 |
Target sample size | 338 |
Countries of recruitment | |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | This study will perform modeling a mathematical model using laboratory values and clinical scores of healthy people and AD patients. The goodness of fit of the model is assessed using an evaluation value calculated from the difference between predicted and measured values when adjusting the model parameters. |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 13age old |
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Age maximum | <= 80age old |
Gender | Both |
Include criteria | Various information (subject background, laboratory values, clinical scores, etc.) obtained in clinical studies in AD patients and healthy subjects (jRCT2080223684, jRCT2080223838, jRCT2080225290, jRCT1030230474) and, where appropriate, in vitro and in vivo data will be used. |
Exclude criteria | Various information (subject background, laboratory values, clinical scores, etc.) obtained in clinical studies in AD patients and healthy subjects (jRCT2080223684, jRCT2080223838, jRCT2080225290, jRCT1030230474) and, where appropriate, in vitro and in vivo data will be used. |
Related Information
Primary Sponsor | Fujita Tomoyuki |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Susumu Hashimoto |
Address | 93 Chudoji Awatacho, Shimogyo-ku, Kyoto Kyoto Japan 600-8815 |
Telephone | +81-75-325-3255 |
hashimoto_dcl@mii.maruho.co.jp | |
Affiliation | Maruho Co.,Ltd. Kyoto R&D Center |
Scientific contact | |
Name | Tomoyuki Fujita |
Address | 93 Chudoji Awatacho, Shimogyo-ku, Kyoto Kyoto Japan 600-8815 |
Telephone | +81-75-325-3255 |
fujita_dzl@mii.maruho.co.jp | |
Affiliation | Maruho Co.,Ltd. Kyoto R&D Center |