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

NCT05004324 | Unknown Phase 3

• 1 other identifier: K0106
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Keywords

Atopic Dermatitis; AD; Stem cell; Furestem

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• EASI(Eczema Area and Severity Index)-75

  2,4,8,12 weeks

• EASI(Eczema Area and Severity Index)-50

  2,4,8 weeks

• EASI(Eczema Area and Severity Index) index

  2,4,8,12 weeks

• IGA(Investigator's Global Assessment) Score

  2,4,8,12 weeks

• SCORAD(SCORing Atopic Dermatitis)-50

  2,4,8,12 weeks

Study Arms (2)

Furestem-AD Inj.

EXPERIMENTAL

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; Biological: Placebo

Placebo

PLACEBO COMPARATOR

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; Biological: Placebo

Interventions

FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL BIOLOGICAL

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

Furestem-AD Inj.; Placebo

Placebo BIOLOGICAL

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

Furestem-AD Inj.; Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Kang Stem Biotech Co., Ltd.: lead

Study Sites (1)

Chosun University Hospital

Gwangju, Jeollanam-do, 61453, South Korea

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noori Kim

CONTACT

2-888-1590; nrkim@kangstem.com

Seulbi Lee

CONTACT

2-888-1590; sblee@kangstem.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: August 13, 2021
• Study Start: June 29, 2021
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)