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

Kang Stem Biotech Co., Ltd.11 sites in 1 country197 target enrollmentApril 25, 2018

ConditionsAtopic Dermatitis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: Kang Stem Biotech Co., Ltd.
Enrollment: 197
Locations: 11
Primary Endpoint: over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 25, 2018

End Date

June 20, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kang Stem Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Of either gender, aged \>=19
•Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
•Chronic Atopic Dermatitis that has been present for at least 3 years
•EASI\>=12 at screening and baseline visit
•IGA\>=3, SCORAD index\>=25, BSA \>=10% of AD involvement at screegning and baseline visit
•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
•Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria

•Subjects with medical history or surgery/procedure history
•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)
•Subjects who need prohibited medication during clinical period
•Pregnant, breast-feeding women or women who plan to become pregnant during this study
•Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
•Any other condition which the investigator judges would make patient unsuitable for study participation

Outcomes

Primary Outcomes

over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)

Time Frame: 12 week

Secondary Outcomes

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)
Total number of use and consumed amount of rescue medicine(24weeks)
Change and rafe of change in Body Surface Area (BSA)(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)
Change in total serum Immunoglobulin E (IgE)(24weeks)
Change and rafe of change in SCORAD index(24weeks)
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)
over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50)(24weeks)