A Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis
Phase 1: Multicenter, repeated administration, disclosure, dose escalation, Evaluate safety and tolerability and explore efficacy Phase 2a: Multicenter, repeated administration, random assignment, double blinding, parallel, Efficacy and safety are evaluated for repeated administration compared to placebo and single administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.
Dongguk University Medical Center
Ilsan, South Korea
COMPLETEDSeoul National Hospital
Seoul, South Korea
RECRUITINGSafety Assessment
safety information including drug tolerability
Time frame: 24 weeks follow-up after first treatment
Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)
Time frame: 24 weeks follow-up after first treatment
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)
Time frame: 24 weeks follow-up after first treatment
Rate of change and Change in EASI from baseline
EASI range is from 0 (clear) to 72 (severe)
Time frame: 24 weeks follow-up after first treatment
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
IGA score is from 0 (clear) to 5 (severe)
Time frame: 24 weeks follow-up after first treatment
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
IGA score is from 0 (clear) to 5 (severe)
Time frame: 24 weeks follow-up after first treatment
Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)
Time frame: 24 weeks follow-up after first treatment
Rate of change and Change in SCORAD index from baseline at each visit
SCORAD index range is from 0 (clear) to 103 (severe)
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Time frame: 24 weeks follow-up after first treatment
Change and rate of change in Body Surface Area (BSA)
Time frame: 24 weeks follow-up after first treatment
Change and rate of change in total serum Immunoglobulin E (IgE)
Time frame: 24 weeks follow-up after first treatment
Change and rate of change in Cytokine
CCL17(TARC), CCL18(PARC), CCL26(eotaxin-3), CCL27(CTACK), IL-4, IL-17A, IL-22, SCCA2
Time frame: 24 weeks follow-up after first treatment
Change and rate of change DLQI
Time frame: 24 weeks follow-up after first treatment
Change and rate of change POEM
Time frame: 24 weeks follow-up after first treatment
Change and rate of change Peak Pruritus NRS
Time frame: 24 weeks follow-up after first treatment
Change and rate of change eosinophil
Time frame: 24 weeks follow-up after first treatment
Use the number and total amount of rescue
only Phase 2a
Time frame: 24 weeks follow-up after first treatment