Dermatitis, Atopic
Conditions
Keywords
Atopic Dermatitis, AD, Stem cell, Furestem
Brief summary
This clinical trial study is two-stage, multi-center, randomized, double-blind, placebo controlled, phase 3 clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic atopic dermatitis.
Interventions
BIOLOGICALFURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL
the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)
BIOLOGICALPlacebo
the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)
Sponsors
Kang Stem Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 19 years and older at time of informed consent 2. Subjects diagnosed with atopic dermatitis based on the Hanifin and Rajka diagnostic criteria 3. Subjects with chronic atopic dermatitis that has been present for at least 1 year before screening 4. Subjects with moderate to severe atopic dermatitis as indicated by: * EASI score ≥ 16 points at the time of screening and baseline (Day 1), * IGA score ≥ 3 points at the time of screening and baseline (Day 1), and * BSA affected by atopic dermatitis ≥ 10% at the time of screening and baseline (Day 1) 5. Subjects who have documented history of insufficient response to stable use of atopic dermatitis treatment within 24 weeks before screening, or inability to receive such treatment because of safety issues 6. Subjects who are willing to apply a stable dose of non-medicated topical moisturizer at least twice daily for at least 7 days before the baseline (Day 1) visit and the duration of the study 7. Women of childbearing potential who use appropriate contraceptive methods during this trial period 8. Subjects who have voluntarily agreed to participate in this trial in writing
Exclusion criteria
1. Subjects with the following history of disease or surgery/procedure at screening 1. Malignancy or lympho-proliferative disease within 5 years before screening (except completely treated carcinoma in situ of the cervix, or completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin) 2. organ transplants 3. History of mental illness, drug or alcohol abuse within 2 years before screening, as per Investigator's opinion 2. Subjects with the following underlying disease at screening 1. Chronic active, acute infection or superficial skin infections requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals or antifungals; 2. Skin diseases, pigmentation, or extensive scarring other than atopic dermatitis that may affect the efficacy evaluations of the study 3. Renal dysfunction with serum creatinine level \> 2.0 mg/dL at screening 4. Liver dysfunction with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 2.5 times the upper limit of the normal range (ULN) at the time of screening 5. Subjects with the history of using leukotriene receptor antagonists, systemic steroids, phototherapy, systemic immunosuppressants/modulators including janus kinase (JAK) inhibitors, and/or any other systemic therapy (not mentioned in
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EASI(Eczema Area and Severity Index)-50 | 12 weeks | Ratio of subject whose Eczema Area and Severity Index (EASI) decreased over 50% as contrasted with baseline value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EASI(Eczema Area and Severity Index)-50 | 2,4,8 weeks | Ratio of subjects whose Eczema Area and Severity Index (EASI) decreased over 50% as contrasted with baseline value |
| EASI(Eczema Area and Severity Index) index | 2,4,8,12 weeks | Change and rate of change in Eczema Area and Severity Index (EASI) index as contrasted with baseline value |
| IGA(Investigator's Global Assessment) Score | 2,4,8,12 weeks | Proportion of subjects who Investigator's Global Assessment (IGA) score 0 or 1 and at least 2 points reduction in IGA score as contrasted with baseline value |
| SCORAD(SCORing Atopic Dermatitis)-50 | 2,4,8,12 weeks | Ratio of subjects whose SCORing Atopic Dermatitis (SCORAD) decreased over 50% as contrasted with baseline value |
| SCORAD(SCORing Atopic Dermatitis) index | 2,4,8,12 weeks | Change and rate of change in SCORing Atopic Dermatitis (SCORAD) index as contrasted with baseline value |
| BSA(Body Surface Area) | 2,4,8,12 weeks | Change and rate of change in Body Surface Area (BSA) as contrasted with baseline value |
| EASI(Eczema Area and Severity Index)-75 | 2,4,8,12 weeks | Ratio of subjects whose Eczema Area and Severity Index (EASI) decreased over 75% as contrasted with baseline value |
| Average daily Pruritus NRS(Numerical Rating Scale) | 2,4,8,12 weeks | Rate of change in Average daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value |
| Worst daily Pruritus NRS(Numerical Rating Scale) - 4 points | 2,4,8,12 weeks | Proportion of patients at least 4 points reduction in Worst daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value |
| POEM(Patient-Oriented Eczema Measure) | 2,4,8,12 weeks | Change and rate of change in Patient-Oriented Eczema Measure (POEM) as contrasted with baseline value |
| DLQI(Dermatology Life Quality Index) | 2,4,8,12 weeks | Change and rate of change in Dermatology Life Quality Index (DLQI) as contrasted with baseline value |
| Rescue medicine | up to 12, 24 weeks | Total number of use and consumed amount of rescue medicine |
| Worst daily Pruritus NRS(Numerical Rating Scale) | 2,4,8,12 weeks | Rate of change in Worst daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value |
Countries
South Korea
Contacts
Primary ContactNoori Kim
Backup ContactSeulbi Lee
Outcome results
None listed