Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)

A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis

This is multi-center, randomized, double-blind, parallel, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic atopic dermatitis

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Biological: FURESTEM-AD Inj.; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Ilsan, Korea, Republic of
    • Dongguk University Medical Center
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Hanyang University Medical Center
  • Seoul, Korea, Republic of, 137-701
    • Catholic Medical Center
  • Seoul, Korea, Republic of
    • Chung-Ang University Healthcare System
  • Suwon, Korea, Republic of
    • Ajou University Hospital

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>=12 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. Subjects who need prohibited medication during clinical period
4. Pregnant, breast-feeding women or women who plan to become pregnant during this study
5. Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
6. 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo; 0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5mL)
EXPERIMENTAL: FURESTEM-AD Inj.; hUCB-MSC 5.0x10^7 cells	Biological: FURESTEM-AD Inj.; 0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5 mL). Treatment group: FURESTEM-AD® inj. 5.0 X 107 cells/1.5 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)	12 week

Secondary Outcome Measures

Outcome Measure	Time Frame
over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75)	12 week
Change and rafe of change in EASI index	24weeks
Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1	24weeks
Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points	24weeks
over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50)	24weeks
Change and rafe of change in SCORAD index	24weeks
Change and rafe of change in Body Surface Area (BSA)	24weeks
Change in total serum Immunoglobulin E (IgE)	24weeks
Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis)	24weeks
Total number of use and consumed amount of rescue medicine	24weeks

Collaborators and Investigators

• Sponsor: Kang Stem Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2018
• Primary Completion (ACTUAL): March 30, 2019
• Study Completion (ACTUAL): June 20, 2019

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (ACTUAL): September 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: eczema; Cell therapy; Atopic Dermatitis; AD; Stem cell; skin disease; dermatitis; furestem; hUCB-MSC; UCB-MSC; Umbilical cord Blood
• 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: K0102

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