Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj

Not yet recruiting

• Conditions: Atopic Dermatitis

• Registration Number: NCT04730024
• Lead Sponsor: Kang Stem Biotech Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-25
• Last Update Submitted: 2021-01-25
• Study First Posted: 2021-01-29
• Last Update Posted: 2021-01-29
• Study Start: 2022-03-27
• Primary Completion: 2030-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

Exclusion Criteria

1. Subjects who are expected to be unable to perform at least one follow-up during this study (K0104-E)
2. 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
3. Subjects who are judged to be unsuitable for other researchers to participate in the research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)	for 5 years

Secondary Outcome Measures

Name	Time	Method
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	SCORAD index range is from 0 (clear) to 103 (severe)
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	EASI range is from 0 (clear) to 72 (severe)
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
Change and rate of change POEM	for 5 years
Change and rate of change in total serum Immunoglobulin E (IgE)	for 5 years

Trial Locations

Locations (1)

Dongguk University Medical Center; 🇰🇷 Ilsan, Korea, Republic of