This study consists of two phases (Phase I and Phase II). Phase II will be conducted sequentially after the safety of SCM-AGH is secured in Phase I. Phase I: Multicenter in Korea, Randomized, Open-label, Parallel arm Phase II: Multicenter in Korea, Double-blind, Placebo-controlled, Parallel arm
Phase I (Multicenter, Randomized, Open-label, Parallel arm Design) Twenty subjects with moderate to severe Atopic Dermatitis(AD) are planned to be enrolled from 6 sites in Korea and administered with SCM-AGH by intravenous (IV) infusion 3 times at two-week intervals and evaluated for safety during the safety evaluation period (12 weeks after first infusion). Phase II (Multicenter, Double-blind, Placebo-controlled, Parallel arm) Phase II of the study is randomized, double-blind, placebo-controlled, parallel arm comparison study in adult subjects with moderate to severe AD. 72 subjects with moderate to severe AD are planned to be enrolled from 6 sites in Korea. Following up to a 4-week Screening period, subjects will be randomly assigned to one of the following treatment arms: SCM-AGH or placebo in the ratio of 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
Inha University Hospital
Incheon, South Korea
over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)
An EASI score is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index). The minimum EASI score is 0 and the maximum EASI score is 72. Higher scores mean worse outcome.
Time frame: Week 12
Score change from Baseline in Eczema Area and Severity Index(EASI) score
An EASI score is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index). The minimum EASI score is 0 and the maximum EASI score is 72. Higher scores mean worse outcome.
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Percentage of subjects who have EASI-75 (improvement of ≥75% in EASI score from Baseline)
An EASI score is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index). The minimum EASI score is 0 and the maximum EASI score is 72. Higher scores mean worse outcome.
Time frame: Weeks 12, 16, 20 and 24
Percentage of subjects who have EASI-90 (improvement of ≥90% in EASI score from Baseline)
An EASI score is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index). The minimum EASI score is 0 and the maximum EASI score is 72. Higher scores mean worse outcome.
Time frame: Weeks 12, 16, 20 and 24
Percentage of subjects who have the Investigator's Global Assessment (IGA) score of 0 or 1
This assessment is the overall investigator's overall global assessment for the whole body. Minimum 0 to Maximum 4. 0 means No inflammatory signs of atopic dermatitis, 4 means Marked erythema \& Disease is widespread in extent.
Time frame: Weeks 12, 16, 20 and 24
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Percentage of subjects whose Investigator Global Assessment (IGA) score is decreased by 2 points or more
This assessment is the overall investigator's overall global assessment for the whole body. Minimum 0 to Maximum 4. 0 means No inflammatory signs of atopic dermatitis, 4 means Marked erythema \& Disease is widespread in extent.
Time frame: Weeks 12, 16, 20 and 24
Score change from Baseline on Pruritus Numerical Rating Scale (NRS)
The NRS is comprised of two items and represents the numbers 0 ("no itch") to 10 ("worst imaginable itch") in the average score of itch and the worst score of itch.
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Percentage of subjects whose Pruritus Numerical Rating Scale (NRS) is improved by 3 points or more
The NRS is comprised of two items and represents the numbers 0 ("no itch") to 10 ("worst imaginable itch") in the average score of itch and the worst score of itch.
Time frame: Weeks 12, 16, 20 and 24
Percentage change from Baseline in Body Surface Area (BSA) affected by Atopic Dermatitis (AD)
BSA involvement of AD will be assessed for each part of the body using "Wallace rule of nines". This BSA is not calculated by weight and height unlike usual BSA calculation, the Wallace rule of nines is a tool used in pre-hospital and emergency medicine to estimate the total body surface area (BSA) affected by a burn. However, this study, the rule of nines will be used to measure the estimated BSA of atopic dermatitis.
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Score change from Baseline in the SCORing Atopic Dermatitis (SCORAD) index
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). Dermatologists may use this tool before and after treatment to determine whether the treatment has been effective. Maximum value is up to 103 which is the worst outcome.
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Score change from Baseline in the Dermatology Life Quality Index (DLQI)
The Dermatology Life Quality Index questionnaire is designed for use in adults. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Score change from Baseline the Patient-Oriented Eczema Measure (POEM)
POEM scores are 0-2 (clear/almost clear); 3-7 (mild); 8-16 (moderate); 17-24 (severe); 25-28 (very severe)
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Change from Baseline in biomarker (Immunoglobulin E [IgE])
biomarkers will be evaluated from the baseline to each time point. Unit of Measure is IU/mL.
Time frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
Change from Baseline in biomarker (eosinophil count)
biomarkers will be evaluated from the baseline to each time point. Unit of measure is cells/μL.
Time frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
Change from Baseline in biomarker (interleukin [IL]-13)
biomarkers will be evaluated from the baseline to each time point. Unit of measure is pg/mL.
Time frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
Change from Baseline in biomarker (interleukin [IL]-17)
biomarkers will be evaluated from the baseline to each time point. Unit of measure is pg/mL.
Time frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
Change from Baseline in biomarker (thymus and activation-regulated chemokine [TARC])
biomarkers will be evaluated from the baseline to each time point. Unit of measure is pg/mL.
Time frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
Change from Baseline in biomarker (interleukin [IL]-22)
biomarkers will be evaluated from the baseline to each time point. Unit of measure is pg/mL.
Time frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24