Safety and Efficacy of FURESTEM-AD Inj. for Moderate to Severe Atopic Dermatitis (AD)

  • STATUS
    Recruiting
  • End date
    Apr 18, 2023
  • participants needed
    308
  • sponsor
    Kang Stem Biotech Co., Ltd.
Updated on 18 August 2021
topical agents

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.

Details
Condition Atopic Dermatitis, ATOPIC DERMATITIS, Eczema (Atopic Dermatitis), Eczéma (Dermatite Atopique), Dermatite Atopique, Dermatitis, Atopic
Treatment Placebo, FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL
Clinical Study IdentifierNCT05004324
SponsorKang Stem Biotech Co., Ltd.
Last Modified on18 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults aged 19 years and older at time of informed consent
Subjects diagnosed with atopic dermatitis based on the Hanifin and Rajka diagnostic criteria
Subjects with chronic atopic dermatitis that has been present for at least 1 year before 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 atopic dermatitis treatment within 24 weeks before screening, or inability to receive such treatment because of safety issues
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
Women of childbearing potential who use appropriate contraceptive methods during this trial period
Subjects who have voluntarily agreed to participate in this trial in writing

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 treated and 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 requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals or antifungals
Skin diseases, pigmentation, or extensive scarring other than atopic dermatitis that 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 time of screening
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 Exclusion Criteria 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, topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs), or topical phosphodiesterase 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 1)
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/parlor within 4 weeks before screening visit
Subjects with the history of a live (attenuated) vaccine injection within 12 weeks before baseline (Day 1) or the plan to inject a live (attenuated) vaccine within 24 weeks after randomization
Subjects who are deemed to require prohibited concomitant medications drug/therapy during the study period
Subjects with uncontrolled chronic disease that might require administration of oral corticosteroids such as uncontrolled and severe asthma
Pregnant/lactating women and men and women of childbearing potential who plan to become pregnant or who refuse to use appropriate contraceptive methods during the study period
Subjects with the history of receipt of any investigational products or devices from another 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 of the Investigator and those with other medical findings that are unsuitable for participation in the study
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