Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results From the K0104 Extension Study

Kang Stem Biotech Co., Ltd.1 site in 1 country102 target enrollmentMarch 27, 2022

ConditionsAtopic Dermatitis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: Kang Stem Biotech Co., Ltd.
Enrollment: 102
Locations: 1
Primary Endpoint: Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
Status: Not Yet Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A multi-center, open, long-term follow-up study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results from the K0104 Extension Study

Registry

clinicaltrials.gov

Start Date

March 27, 2022

End Date

June 30, 2030

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Kang Stem Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject who enrolled K0104 Clinical Trial(parent study).
•Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria

•Subjects who are expected to be unable to perform at least one follow-up during this study (K0104-E)
•Subjects who has received/administered clinical trial drugs or medical devices by participating in other clinical trials until the first visit of this trial (K0104-E) after the completion of K0104 clinical trial
•Subjects who are judged to be unsuitable for other researchers to participate in the research

Outcomes

Primary Outcomes

Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)

Time Frame: for 5 years

Secondary Outcomes

Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1(for 5 years)
Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)(for 5 years)
Change and rate of change in Body Surface Area (BSA)(for 5 years)
Change and rate of change DLQI(for 5 years)
Change and rate of change Peak Pruritus NRS(for 5 years)
Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)(for 5 years)
Rate of change and Change in EASI from baseline(for 5 years)
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)(for 5 years)
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher(for 5 years)
Rate of change and Change in SCORAD index from baseline at each visit(for 5 years)
Change and rate of change POEM(for 5 years)
Change and rate of change in total serum Immunoglobulin E (IgE)(for 5 years)