Last updated: August 5, 2021
Sponsor: Kang Stem Biotech Co., Ltd.
Overall Status: Active - Recruiting
Phase
3
Condition
Allergy
Dermatitis, Atopic
Atopic Dermatitis
Treatment
N/AClinical Study ID
NCT05004324
K0106
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adults aged 19 years and older at time of informed consent
- Subjects diagnosed with atopic dermatitis based on the Hanifin and Rajka diagnosticcriteria
- Subjects with chronic atopic dermatitis that has been present for at least 1 yearbefore screening
- 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)
- Subjects who have documented history of insufficient response to stable use of atopicdermatitis treatment within 24 weeks before screening, or inability to receive suchtreatment because of safety issues
- Subjects who are willing to apply a stable dose of non-medicated topical moisturizerat least twice daily for at least 7 days before the baseline (Day 1) visit and theduration of the study
- Women of childbearing potential who use appropriate contraceptive methods during thistrial period
- Subjects who have voluntarily agreed to participate in this trial in writing
Exclusion
Exclusion Criteria:
- Subjects with the following history of disease or surgery/procedure at screening
- Malignancy or lympho-proliferative disease within 5 years before screening (except completely treated carcinoma in situ of the cervix, or completely treatedand resolved non-metastatic squamous or basal cell carcinoma of the skin)
- organ transplants
- History of mental illness, drug or alcohol abuse within 2 years before screening,as per Investigator's opinion
- Subjects with the following underlying disease at screening
- Chronic active, acute infection or superficial skin infections requiringtreatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoalsor antifungals;
- Skin diseases, pigmentation, or extensive scarring other than atopic dermatitisthat may affect the efficacy evaluations of the study
- Renal dysfunction with serum creatinine level > 2.0 mg/dL at screening
- 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 timeof screening
- Subjects with the history of using leukotriene receptor antagonists, systemicsteroids, phototherapy, systemic immunosuppressants/modulators including janus kinase (JAK) inhibitors, and/or any other systemic therapy (not mentioned in ExclusionCriteria 6 and 8) to treat atopic dermatitis or symptoms of atopic dermatitis (approved or off-label use) within 4 weeks before baseline (Day 1)
- Subjects with the history of using systemic or topical antihistamines, topicalcorticosteroids (TCS), topical calcineurin inhibitors (TCIs), or topicalphosphodiesterase 4 (PDE4) inhibitors within 2 weeks before baseline (Day 1)
- Allergen immunotherapy within 6 months before baseline (Day 1)
- Subjects with the history of receipt of the following treatments before baseline (Day
- B cell-depleting agents including rituximab within 6 months
- Other biologics including dupilumab within 5 half-lives (if known) or 12 weeks,whichever is longer
- Subjects with regular use (more than two times per a week) of a tanning booth/parlorwithin 4 weeks before screening visit
- Subjects with the history of a live (attenuated) vaccine injection within 12 weeksbefore baseline (Day 1) or the plan to inject a live (attenuated) vaccine within 24weeks after randomization
- Subjects who are deemed to require prohibited concomitant medications drug/therapyduring the study period
- Subjects with uncontrolled chronic disease that might require administration of oralcorticosteroids such as uncontrolled and severe asthma
- Pregnant/lactating women and men and women of childbearing potential who plan tobecome pregnant or who refuse to use appropriate contraceptive methods during thestudy period
- Subjects with the history of receipt of any investigational products or devices fromanother clinical trial within 4 weeks or 5 half-lives (if known) pior to screening
- Positive serology for hepatitis B or C, or for HIV
- Subjects with prior use of FURESTEM-AD
- Subjects with history of anaphylaxis
- Subjects who are deemed to have difficulty in performing this study by the judgment ofthe Investigator and those with other medical findings that are unsuitable forparticipation in the study
Study Design
Total Participants: 308
Study Start date:
June 29, 2021
Estimated Completion Date:
April 30, 2023
Connect with a study center
Chosun University Hospital
Gwangju, Jeollanam-do 61453
Korea, Republic ofActive - Recruiting

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