Clinical trial NCT04725136: Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Atopic Dermatitis
Keywords: hUCB-MSC
Atopic Dermatitis
Lead sponsor: Kang Stem Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-26
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

1. Of either gender, aged \>=19
2. Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
3. Chronic Atopic Dermatitis that has been present for at least 3 years
4. EASI\>=16 at screening and baseline visit
5. IGA\>=3, SCORAD index\>=25, BSA \>=10% of AD involvement at screegning and baseline visit
6. 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
7. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. Subjects with medical history or surgery/procedure history
2. 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)
3. Renal dysfunction with creatinine \>2.0 mg/dL at screening
4. Hepatic dysfunction with ALT or AST levels 2.5 times higher than the normal range at screening
5. ALC\<800/mm3 at screening
6. Subjects with live vaccine administration within 12 weeks before baseline
7. 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
8. Receipt of topical steroids(class1\~6), topical tacrolimus or pimecrolimus within 2 weeks before Baseline
9. Subjects who need prohibited medication during clinical period
10. Pregnant, breast-feeding women or women who plan to become pregnant during this study
11. Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
12. Subjects with experience of administering FURESTEM-AD inj.
13. Any other condition which the investigator judges would make patient unsuitable for study participation

Primary outcomes:
measure: Safety Assessment
timeFrame: 24 weeks follow-up after first treatment
Secondary outcomes:
measure: Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)
timeFrame: 24 weeks follow-up after first treatment
measure: Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)
timeFrame: 24 weeks follow-up after first treatment
measure: Rate of change and Change in EASI from baseline
timeFrame: 24 weeks follow-up after first treatment
measure: Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
timeFrame: 24 weeks follow-up after first treatment
measure: Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
timeFrame: 24 weeks follow-up after first treatment
measure: Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)
timeFrame: 24 weeks follow-up after first treatment
measure: Rate of change and Change in SCORAD index from baseline at each visit
timeFrame: 24 weeks follow-up after first treatment
measure: Change and rate of change in Body Surface Area (BSA)
timeFrame: 24 weeks follow-up after first treatment
measure: Change and rate of change in total serum Immunoglobulin E (IgE)
timeFrame: 24 weeks follow-up after first treatment
measure: Change and rate of change in Cytokine
timeFrame: 24 weeks follow-up after first treatment
measure: Change and rate of change DLQI
timeFrame: 24 weeks follow-up after first treatment
measure: Change and rate of change POEM
timeFrame: 24 weeks follow-up after first treatment
measure: Change and rate of change Peak Pruritus NRS
timeFrame: 24 weeks follow-up after first treatment
measure: Change and rate of change eosinophil
timeFrame: 24 weeks follow-up after first treatment
measure: Use the number and total amount of rescue
timeFrame: 24 weeks follow-up after first treatment
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: Dongguk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National Hospital
Study officials:
References: