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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Biological: FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL; Biological: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 308
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Noori Kim; Phone Number: 82 2-888-1590; Email: nrkim@kangstem.com
• Study Contact Backup: Name: Seulbi Lee; Phone Number: 82 2-888-1590; Email: sblee@kangstem.com

Study Locations

• Korea, Republic of
  • Jeollanam-do
    • Gwangju, Jeollanam-do, Korea, Republic of, 61453
      • Recruiting
      • Chosun university hospital
      • Contact: Chanho Na, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EASI(Eczema Area and Severity Index)-50	Ratio of subject whose Eczema Area and Severity Index (EASI) decreased over 50% as contrasted with baseline value	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EASI(Eczema Area and Severity Index)-75	Ratio of subjects whose Eczema Area and Severity Index (EASI) decreased over 75% as contrasted with baseline value	2,4,8,12 weeks
EASI(Eczema Area and Severity Index)-50	Ratio of subjects whose Eczema Area and Severity Index (EASI) decreased over 50% as contrasted with baseline value	2,4,8 weeks
EASI(Eczema Area and Severity Index) index	Change and rate of change in Eczema Area and Severity Index (EASI) index as contrasted with baseline value	2,4,8,12 weeks
IGA(Investigator's Global Assessment) Score	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	2,4,8,12 weeks
SCORAD(SCORing Atopic Dermatitis)-50	Ratio of subjects whose SCORing Atopic Dermatitis (SCORAD) decreased over 50% as contrasted with baseline value	2,4,8,12 weeks
SCORAD(SCORing Atopic Dermatitis) index	Change and rate of change in SCORing Atopic Dermatitis (SCORAD) index as contrasted with baseline value	2,4,8,12 weeks
BSA(Body Surface Area)	Change and rate of change in Body Surface Area (BSA) as contrasted with baseline value	2,4,8,12 weeks
Worst daily Pruritus NRS(Numerical Rating Scale)	Rate of change in Worst daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value	2,4,8,12 weeks
Average daily Pruritus NRS(Numerical Rating Scale)	Rate of change in Average daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value	2,4,8,12 weeks
Worst daily Pruritus NRS(Numerical Rating Scale) - 4 points	Proportion of patients at least 4 points reduction in Worst daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value	2,4,8,12 weeks
POEM(Patient-Oriented Eczema Measure)	Change and rate of change in Patient-Oriented Eczema Measure (POEM) as contrasted with baseline value	2,4,8,12 weeks
DLQI(Dermatology Life Quality Index)	Change and rate of change in Dermatology Life Quality Index (DLQI) as contrasted with baseline value	2,4,8,12 weeks
Rescue medicine	Total number of use and consumed amount of rescue medicine	up to 12, 24 weeks

Collaborators and Investigators

• Sponsor: Kang Stem Biotech Co., Ltd.
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; AD; Stem cell; Furestem
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: K0106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No