Clinical trial NCT03269773: Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)
Official title: A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Stem cell
Cell therapy
skin disease
Umbilical cord Blood
UCB-MSC
hUCB-MSC
AD
furestem
dermatitis
eczema
Lead sponsor: Kang Stem Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-09-01
Enrollment: 197
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: This is multi-center, randomized, double-blind, parallel, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic atopic dermatitis


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\>=12 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. Subjects who need prohibited medication during clinical period
4. Pregnant, breast-feeding women or women who plan to become pregnant during this study
5. Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
6. Any other condition which the investigator judges would make patient unsuitable for study participation

Primary outcomes:
measure: over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)
timeFrame: 12 week
Secondary outcomes:
measure: over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75)
timeFrame: 12 week
measure: Change and rafe of change in EASI index
timeFrame: 24weeks
measure: Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1
timeFrame: 24weeks
measure: Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points
timeFrame: 24weeks
measure: over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50)
timeFrame: 24weeks
measure: Change and rafe of change in SCORAD index
timeFrame: 24weeks
measure: Change and rafe of change in Body Surface Area (BSA)
timeFrame: 24weeks
measure: Change in total serum Immunoglobulin E (IgE)
timeFrame: 24weeks
measure: Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis)
timeFrame: 24weeks
measure: Total number of use and consumed amount of rescue medicine
timeFrame: 24weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: Dongguk University Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Catholic Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Healthcare System
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References: