Clinical trial NCT05004324: Safety and Efficacy of FURESTEM-AD Inj. for Moderate to Severe Atopic Dermatitis (AD)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dermatitis, Atopic
Keywords: Atopic Dermatitis
AD
Stem cell
Furestem
Lead sponsor: Kang Stem Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-13
Enrollment: 308
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: EASI(Eczema Area and Severity Index)-50
timeFrame: 12 weeks
Secondary outcomes:
measure: EASI(Eczema Area and Severity Index)-75
timeFrame: 2,4,8,12 weeks
measure: EASI(Eczema Area and Severity Index)-50
timeFrame: 2,4,8 weeks
measure: EASI(Eczema Area and Severity Index) index
timeFrame: 2,4,8,12 weeks
measure: IGA(Investigator's Global Assessment) Score
timeFrame: 2,4,8,12 weeks
measure: SCORAD(SCORing Atopic Dermatitis)-50
timeFrame: 2,4,8,12 weeks
measure: SCORAD(SCORing Atopic Dermatitis) index
timeFrame: 2,4,8,12 weeks
measure: BSA(Body Surface Area)
timeFrame: 2,4,8,12 weeks
measure: Worst daily Pruritus NRS(Numerical Rating Scale)
timeFrame: 2,4,8,12 weeks
measure: Average daily Pruritus NRS(Numerical Rating Scale)
timeFrame: 2,4,8,12 weeks
measure: Worst daily Pruritus NRS(Numerical Rating Scale) - 4 points
timeFrame: 2,4,8,12 weeks
measure: POEM(Patient-Oriented Eczema Measure)
timeFrame: 2,4,8,12 weeks
measure: DLQI(Dermatology Life Quality Index)
timeFrame: 2,4,8,12 weeks
measure: Rescue medicine
timeFrame: up to 12, 24 weeks
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
state: Jeollanam-do
Study officials:
affiliation: Bucheon Hospital, Soonchunhyang University
name: Yeonglib Park, professor (CI)
role: PRINCIPAL_INVESTIGATOR
affiliation: Konkuk University Hospital
name: Yangwon Lee, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University
name: Sanguk Son, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Gangdong Kyunghee University Hospital
name: Bakrin Yoo, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St. Mary's Hospital
name: Jihyun Lee, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Donghoon Lee, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Chosun University Hospital
name: Chanho Na, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Dongtan Seongsim Hospital
name: Yooin Bae, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Yangsan Pusan National University Hospital
name: Hyunchang Ko, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: Younghyun Jang, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea Eunpyeong St. Mary's Hospital
name: Jeongeun Kim, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyunghee University Hospital
name: Minkyung Shin, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University Incheon St. Mary's Hospital
name: Sanghyun Cho, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Gangnam Seongsim Hospital
name: Cheonuk Park, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Jooyeon Ko, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Nowon Eulji University Hospital
name: Taeyoung Han, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: National medical center
name: Jiyoung Ahn, professor
role: PRINCIPAL_INVESTIGATOR
References: