Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Biological: FURESTEM-AD inj


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Of either gender, aged >=19 Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria Chronic Atopic Dermatitis that has been present for at least 3 years EASI>=16 at screening and baseline visit IGA>=3, SCORAD index>=25, BSA >=10% of AD involvement at screegning and baseline visit Subjects with documented record of inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks before participating in the study, or whom are inadvisable due to safety risks Subjects who understand and voluntarily sign an informed consent form Exclusion Criteria: Subjects with medical history or surgery/procedure history Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region) Renal dysfunction with creatinine >2.0 mg/dL at screening Hepatic dysfunction with ALT or AST levels 2.5 times higher than the normal range at screening ALC<800/mm3 at screening Subjects with live vaccine administration within 12 weeks before baseline Receipt of leukotriene receptor antagonists, systemic steroids, systemic or topical antihistamines, phototherapy, or systemic immunosuppressants/modulators including janus kinase (JAK) inhibitors, and/or any other systemic therapy within 4 weeks before Baseline Receipt of topical steroids(class1 6), topical tacrolimus or pimecrolimus within 2 weeks before Baseline Subjects who need prohibited medication during clinical period Pregnant, breast-feeding women or women who plan to become pregnant during this study Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks Subjects with experience of administering FURESTEM-AD inj. Any other condition which the investigator judges would make patient unsuitable for study participation

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose repeat administration group<br>FURESTEM-AD Inj 1.0 x 10^8 cells /body 3 repeated subcutaneous injection at 4 week intervals | Biological: FURESTEM-AD inj<br>* 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.<br>|
| Experimental: High-dose single administration group<br>FURESTEM-AD Inj 1.0 x 10^8 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals | Biological: FURESTEM-AD inj<br>* 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.<br>|
| Experimental: Low-dose repeat administration group<br>FURESTEM-AD Inj 5.0 x 10^7 cells /body 3 repeated subcutaneous injection at 4 week intervals | Biological: FURESTEM-AD inj<br>* 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.<br>|
| Experimental: Low-dose single administration group<br>FURESTEM-AD Inj 5.0 x 10^7 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals | Biological: FURESTEM-AD inj<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Normal saline(0.9% NaCl) 3 repeated subcutaneous injection at 4 week intervals | Biological: FURESTEM-AD inj<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | safety information including drug tolerability | 24 weeks follow-up after first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50) |  | 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) |  | 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) | 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) | 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) | 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) |  | 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) | 24 weeks follow-up after first treatment | 
| Change and rate of change in Body Surface Area (BSA) |  | 24 weeks follow-up after first treatment | 
| Change and rate of change in total serum Immunoglobulin E (IgE) |  | 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 | 24 weeks follow-up after first treatment | 
| Change and rate of change DLQI |  | 24 weeks follow-up after first treatment | 
| Change and rate of change POEM |  | 24 weeks follow-up after first treatment | 
| Change and rate of change Peak Pruritus NRS |  | 24 weeks follow-up after first treatment | 
| Change and rate of change eosinophil |  | 24 weeks follow-up after first treatment | 
| Use the number and total amount of rescue | only Phase 2a | 24 weeks follow-up after first treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hUCB-MSC, Atopic Dermatitis