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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04730024
• Other study ID #: K0104-E
• Status: Not yet recruiting
• Start date: March 27, 2022
• Est. completion date: June 30, 2030

Study information

• Verified date: January 2021
• Source: Kang Stem Biotech Co., Ltd.
• Contact: Eundoek Yeo
• Phone: 82-2-888-1592
• Email: edyeo[@]kangstem.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Not applicable(observational study)
Not applicable(observational study)

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Medical Center	Ilsan

Sponsors (1)

Lead Sponsor	Collaborator
Kang Stem Biotech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)		for 5 years
Secondary	Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)		for 5 years
Secondary	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
Secondary	Rate of change and Change in EASI from baseline	EASI range is from 0 (clear) to 72 (severe)	for 5 years
Secondary	Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1		for 5 years
Secondary	Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher		for 5 years
Secondary	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
Secondary	Rate of change and Change in SCORAD index from baseline at each visit	SCORAD index range is from 0 (clear) to 103 (severe)	for 5 years
Secondary	Change and rate of change in Body Surface Area (BSA)		for 5 years
Secondary	Change and rate of change in total serum Immunoglobulin E (IgE)		for 5 years
Secondary	Change and rate of change DLQI		for 5 years
Secondary	Change and rate of change POEM		for 5 years
Secondary	Change and rate of change Peak Pruritus NRS		for 5 years