Incidence, severity and relationship of adverse events(AEs) [ Time Frame: Baseline to Week 26 ]
Incidence, severity and relationship of adverse events as assessed by CTCAE v5.0
Number of abnormalities and change from baseline in Vital signs [ Time Frame: Baseline to Week 26 ]
Supine blood pressure and pulse rate, tympanic temperature, and respiratory rate
Number of abnormalities in 12-lead electrocardiogram (ECG) [ Time Frame: Baseline to Week 26 ]
PR interval, QRS interval, RR interval, QT interval and QT interval using Friderica’s correction (QTcF)
Number of abnormalities in clinical laboratory parameter [ Time Frame: Baseline to Week 26 ]
Hematology, clinical chemistry, and urinalysis parameters
Frequency and proportion of clinically significant finding of physical examination [ Time Frame: Baseline to Week 26 ]
Assessments of the following body categories : skin, HEENT (head, eye, ears, nose, and throat), cardiovascular, respiratory, gastrointestinal, endocrine/metabolic, genitourinary, psychiatric, hematologic/lymphatics, musculoskeletal, neurologic, hepatic, and allergic/immunologic
Proportion of patients who achieved the Investigator’s Global Assessment (IGA) score of 0 or 1 [ Time Frame: Baseline to Week 8 ]
The IGA is an assessment instrument used in clinical studies to rate the severity of Atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Change and percent change in Body Surface Area (BSA) [ Time Frame: Baseline to Week 8 ]
The BSA affected by atopic dermatitis will be assessed for each major section of the body (head, trunk, arms, and legs). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Change and percent change in Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to Week 8 ]
The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.
Change and percent change in Scoring Atopic Dermatitis (SCORAD) [ Time Frame: Baseline to Week 8 ]
The SCORAD is a clinical tool for assessing the severity of Atopic Dermatitis. Total score ranged from 0 (absent disease) to 103 (severe disease).
Change and percent change in Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to Week 8 ]
The Pruritus NRS is a simple assessment tool used to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being ‘no itch’ and 10 being the’ worst itch imaginable’
Change and percent change in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline to Week 8 ]
The DLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life
Change and percent change in Patient-Oriented Eczema Measure (POEM) [ Time Frame: Baseline to Week 8 ]
The POEM is a validated 7-item questionnaire used to assess disease symptoms with a scoring system of 1 to 28. The higher score, the higher morbidity
Source: View full study details on ClinicalTrials.gov
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