Evalution the Safety and Efficacy in Atopic Dermatitis Patients

• Conditions: Atopic Dermatitis
• Interventions: Other: Not applicable(observational study)

• Registration Number: NCT03962387
• Lead Sponsor: Kang Stem Biotech Co., Ltd.

Brief Summary

A multi-center, open, long-term follow-up study to evaluate the efficacy and safety of FURESTEM-AD inj. in patients with moderate to severe chronic atopic dermatitis: 5-year results from the K0102 extension study

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-28
• Study Start: 2019-04-05
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-24
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-16
• Primary Completion: 2024-01-02
• Study Completion: 2024-01-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1. Subject who enrolled K0102 Clinical Trial(parent study).
2. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria

1. In case follow-up is not possible from end of K0102 clinical trial to end of this study period
2. Any other condition which the investigator judges would make patient unsuitable for study participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atopic Dermatitis	Not applicable(observational study)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of change in EASI from baseline	3 years
Change in EASI from baseline	3 years	EASI range is from 0 (clear) to 72 (severe)
Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)	3 years
Rate of change in SCORAD index from baseline at each visit	3 years
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at Week 12 (EASI-75)	3 years
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at Week 12 (EASI-50)	3 years
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1	3 years
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher	3 years
Change in SCORAD index from baseline at each visit	3 years	SCORAD index range is from 0 (clear) to 103 (severe)
Rate of change in Body Surface Area(BSA) of the lesion from baseline	3 years
Change in Body Surface Area(BSA) of the lesion from baseline	3 years	BSA range is from 0 (clear) to 100 (severe)
Change in total serum Immunoglobulin E(IgE) from baseline	3 years

Trial Locations

Locations (1)

The Catholic University of Korea, Seoul ST. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of