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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05004324
Recruitment Status : Recruiting
First Posted : August 13, 2021
Last Update Posted : August 13, 2021
Sponsor:
Information provided by (Responsible Party):
Kang Stem Biotech Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Biological: FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 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
Actual Study Start Date : June 29, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Furestem-AD Inj.

Investigational product name: FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL

baseline (0week) Experimental group will receive Investigational product (FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL).

After 12 weeks, Experimental group will receive placebo.

Biological: FURESTEM-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)

Biological: Placebo
the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)

Placebo Comparator: Placebo

Placebo

baseline (0week) Placebo comparator group will receive placebo.

After 12 weeks, Placebo comparator group will receive Investigational product (FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL).

Biological: FURESTEM-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)

Biological: Placebo
the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)




Primary Outcome Measures :
  1. EASI(Eczema Area and Severity Index)-50 [ Time Frame: 12 weeks ]
    Ratio of subject whose Eczema Area and Severity Index (EASI) decreased over 50% as contrasted with baseline value


Secondary Outcome Measures :
  1. EASI(Eczema Area and Severity Index)-75 [ Time Frame: 2,4,8,12 weeks ]
    Ratio of subjects whose Eczema Area and Severity Index (EASI) decreased over 75% as contrasted with baseline value

  2. EASI(Eczema Area and Severity Index)-50 [ Time Frame: 2,4,8 weeks ]
    Ratio of subjects whose Eczema Area and Severity Index (EASI) decreased over 50% as contrasted with baseline value

  3. EASI(Eczema Area and Severity Index) index [ Time Frame: 2,4,8,12 weeks ]
    Change and rate of change in Eczema Area and Severity Index (EASI) index as contrasted with baseline value

  4. IGA(Investigator's Global Assessment) Score [ Time Frame: 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

  5. SCORAD(SCORing Atopic Dermatitis)-50 [ Time Frame: 2,4,8,12 weeks ]
    Ratio of subjects whose SCORing Atopic Dermatitis (SCORAD) decreased over 50% as contrasted with baseline value

  6. SCORAD(SCORing Atopic Dermatitis) index [ Time Frame: 2,4,8,12 weeks ]
    Change and rate of change in SCORing Atopic Dermatitis (SCORAD) index as contrasted with baseline value

  7. BSA(Body Surface Area) [ Time Frame: 2,4,8,12 weeks ]
    Change and rate of change in Body Surface Area (BSA) as contrasted with baseline value

  8. Worst daily Pruritus NRS(Numerical Rating Scale) [ Time Frame: 2,4,8,12 weeks ]
    Rate of change in Worst daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value

  9. Average daily Pruritus NRS(Numerical Rating Scale) [ Time Frame: 2,4,8,12 weeks ]
    Rate of change in Average daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value

  10. Worst daily Pruritus NRS(Numerical Rating Scale) - 4 points [ Time Frame: 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

  11. POEM(Patient-Oriented Eczema Measure) [ Time Frame: 2,4,8,12 weeks ]
    Change and rate of change in Patient-Oriented Eczema Measure (POEM) as contrasted with baseline value

  12. DLQI(Dermatology Life Quality Index) [ Time Frame: 2,4,8,12 weeks ]
    Change and rate of change in Dermatology Life Quality Index (DLQI) as contrasted with baseline value

  13. Rescue medicine [ Time Frame: up to 12, 24 weeks ]
    Total number of use and consumed amount of rescue medicine



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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)
  6. 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)
  7. Allergen immunotherapy within 6 months before baseline (Day 1)
  8. Subjects with the history of receipt of the following treatments before baseline (Day 1)

    1. B cell-depleting agents including rituximab within 6 months
    2. Other biologics including dupilumab within 5 half-lives (if known) or 12 weeks, whichever is longer
  9. Subjects with regular use (more than two times per a week) of a tanning booth/parlor within 4 weeks before screening visit
  10. 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
  11. Subjects who are deemed to require prohibited concomitant medications drug/therapy during the study period
  12. Subjects with uncontrolled chronic disease that might require administration of oral corticosteroids such as uncontrolled and severe asthma
  13. 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
  14. 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
  15. Positive serology for hepatitis B or C, or for HIV
  16. Subjects with prior use of FURESTEM-AD
  17. Subjects with history of anaphylaxis
  18. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05004324


Contacts
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Contact: Noori Kim 2-888-1590 ext 82 nrkim@kangstem.com
Contact: Seulbi Lee 2-888-1590 ext 82 sblee@kangstem.com

Locations
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Korea, Republic of
Chosun University Hospital Recruiting
Gwangju, Jeollanam-do, Korea, Republic of, 61453
Contact: Chanho Na, professor         
Sponsors and Collaborators
Kang Stem Biotech Co., Ltd.
Investigators
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Principal Investigator: Yeonglib Park, professor (CI) Bucheon Hospital, Soonchunhyang University
Principal Investigator: Yangwon Lee, professor Konkuk University Hospital
Principal Investigator: Sanguk Son, professor Korea University
Principal Investigator: Bakrin Yoo, professor Gangdong Kyunghee University Hospital
Principal Investigator: Jihyun Lee, professor Seoul St. Mary's Hospital
Principal Investigator: Donghoon Lee, professor Seoul National University Hospital
Principal Investigator: Chanho Na, professor Chosun University Hospital
Principal Investigator: Yooin Bae, professor Hallym University Dongtan Seongsim Hospital
Principal Investigator: Hyunchang Ko, professor Yangsan Pusan National University Hospital
Principal Investigator: Younghyun Jang, professor Kyungpook National University Hospital
Principal Investigator: Jeongeun Kim, professor The Catholic University of Korea Eunpyeong St. Mary's Hospital
Principal Investigator: Minkyung Shin, professor Kyunghee University Hospital
Principal Investigator: Sanghyun Cho, professor Catholic University Incheon St. Mary's Hospital
Principal Investigator: Cheonuk Park, professor Hallym University Gangnam Seongsim Hospital
Principal Investigator: Jooyeon Ko, professor Hanyang University
Principal Investigator: Taeyoung Han, professor Nowon Eulji University Hospital
Principal Investigator: Jiyoung Ahn, professor National Medical Center
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Responsible Party: Kang Stem Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT05004324    
Other Study ID Numbers: K0106
First Posted: August 13, 2021    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kang Stem Biotech Co., Ltd.:
Atopic Dermatitis
AD
Stem cell
Furestem
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases