Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High-dose repeat administration group FURESTEM-AD Inj 1.0 x 10^8 cells /body 3 repeated subcutaneous injection at 4 week intervals |
Biological: FURESTEM-AD inj
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.
|
| Experimental: High-dose single administration group 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
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.
|
| Experimental: Low-dose repeat administration group FURESTEM-AD Inj 5.0 x 10^7 cells /body 3 repeated subcutaneous injection at 4 week intervals |
Biological: FURESTEM-AD inj
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.
|
| Experimental: Low-dose single administration group 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
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.
|
| Placebo Comparator: Placebo Normal saline(0.9% NaCl) 3 repeated subcutaneous injection at 4 week intervals |
Biological: FURESTEM-AD inj
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.
|
Outcome Measures
Primary Outcome Measures
- Safety Assessment [24 weeks follow-up after first treatment]
safety information including drug tolerability
Secondary Outcome Measures
- 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 [24 weeks follow-up after first treatment]
EASI range is from 0 (clear) to 72 (severe)
- Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1 [24 weeks follow-up after first treatment]
IGA score is from 0 (clear) to 5 (severe)
- Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher [24 weeks follow-up after first treatment]
IGA score is from 0 (clear) to 5 (severe)
- 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 [24 weeks follow-up after first treatment]
SCORAD index range is from 0 (clear) to 103 (severe)
- 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 [24 weeks follow-up after first treatment]
CCL17(TARC), CCL18(PARC), CCL26(eotaxin-3), CCL27(CTACK), IL-4, IL-17A, IL-22, SCCA2
- 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 [24 weeks follow-up after first treatment]
only Phase 2a
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dongguk University Medical Center | Ilsan | Korea, Republic of | ||
| 2 | Seoul National Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Kang Stem Biotech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K0104