Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis

A Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis

A Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Biological: FURESTEM-AD inj

Detailed Description

Phase 1: Multicenter, repeated administration, disclosure, dose escalation, Evaluate safety and tolerability and explore efficacy

Phase 2a: Multicenter, repeated administration, random assignment, double blinding, parallel, Efficacy and safety are evaluated for repeated administration compared to placebo and single administration.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Eundeok Yeo; Phone Number: 82-2-888-1592; Email: edyeo@kangstem.com

Study Locations

• Korea, Republic of
  • Ilsan, Korea, Republic of
    • Completed
    • Dongguk University Medical Center
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National Hospital
    • Contact: Donghoon Lee, 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. Of either gender, aged >=19
2. Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
3. Chronic Atopic Dermatitis that has been present for at least 3 years
4. EASI>=16 at screening and baseline visit
5. IGA>=3, SCORAD index>=25, BSA >=10% of AD involvement at screegning and baseline visit
6. Subjects with documented record of inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks before participating in the study, or whom are inadvisable due to safety risks
7. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. Subjects with medical history or surgery/procedure history
2. Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region)
3. Renal dysfunction with creatinine >2.0 mg/dL at screening
4. Hepatic dysfunction with ALT or AST levels 2.5 times higher than the normal range at screening
5. ALC<800/mm3 at screening
6. Subjects with live vaccine administration within 12 weeks before baseline
7. Receipt of leukotriene receptor antagonists, systemic steroids, systemic or topical antihistamines, phototherapy, or systemic immunosuppressants/modulators including janus kinase (JAK) inhibitors, and/or any other systemic therapy within 4 weeks before Baseline
8. Receipt of topical steroids(class1~6), topical tacrolimus or pimecrolimus within 2 weeks before Baseline
9. Subjects who need prohibited medication during clinical period
10. Pregnant, breast-feeding women or women who plan to become pregnant during this study
11. Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
12. Subjects with experience of administering FURESTEM-AD inj.
13. Any other condition which the investigator judges would make patient unsuitable for study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High-dose repeat administration group; FURESTEM-AD Inj 1.0 x 10^8 cells /body 3 repeated subcutaneous injection at 4 week intervals	Biological: FURESTEM-AD inj; Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.
EXPERIMENTAL: High-dose single administration group; FURESTEM-AD Inj 1.0 x 10^8 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals	Biological: FURESTEM-AD inj; Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.
EXPERIMENTAL: Low-dose repeat administration group; FURESTEM-AD Inj 5.0 x 10^7 cells /body 3 repeated subcutaneous injection at 4 week intervals	Biological: FURESTEM-AD inj; Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.
EXPERIMENTAL: Low-dose single administration group; FURESTEM-AD Inj 5.0 x 10^7 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals	Biological: FURESTEM-AD inj; Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.
PLACEBO_COMPARATOR: Placebo; Normal saline(0.9% NaCl) 3 repeated subcutaneous injection at 4 week intervals	Biological: FURESTEM-AD inj; Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment	safety information including drug tolerability	24 weeks follow-up after first treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)		24 weeks follow-up after first treatment
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)		24 weeks follow-up after first treatment
Rate of change and Change in EASI from baseline	EASI range is from 0 (clear) to 72 (severe)	24 weeks follow-up after first treatment
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1	IGA score is from 0 (clear) to 5 (severe)	24 weeks follow-up after first treatment
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher	IGA score is from 0 (clear) to 5 (severe)	24 weeks follow-up after first treatment
Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)		24 weeks follow-up after first treatment
Rate of change and Change in SCORAD index from baseline at each visit	SCORAD index range is from 0 (clear) to 103 (severe)	24 weeks follow-up after first treatment
Change and rate of change in Body Surface Area (BSA)		24 weeks follow-up after first treatment
Change and rate of change in total serum Immunoglobulin E (IgE)		24 weeks follow-up after first treatment
Change and rate of change in Cytokine	CCL17(TARC), CCL18(PARC), CCL26(eotaxin-3), CCL27(CTACK), IL-4, IL-17A, IL-22, SCCA2	24 weeks follow-up after first treatment
Change and rate of change DLQI		24 weeks follow-up after first treatment
Change and rate of change POEM		24 weeks follow-up after first treatment
Change and rate of change Peak Pruritus NRS		24 weeks follow-up after first treatment
Change and rate of change eosinophil		24 weeks follow-up after first treatment
Use the number and total amount of rescue	only Phase 2a	24 weeks follow-up after first treatment

Collaborators and Investigators

• Sponsor: Kang Stem Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 27, 2021
• Primary Completion (ANTICIPATED): January 31, 2023
• Study Completion (ANTICIPATED): May 31, 2023

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (ACTUAL): January 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; hUCB-MSC
• 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: K0104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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