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

NCT04730024 | Not Yet Recruiting

• 1 other identifier: K0104-E
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

  for 5 years

Secondary Outcomes (12)

• Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)

  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

• Rate of change and Change in EASI from baseline

  for 5 years

• Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1

  for 5 years

• Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher

  for 5 years

Interventions

Not applicable(observational study) OTHER

Not applicable(observational study)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this study (K0104-E), it was planned to select subjects who participated in the K0104 clinical trial, a parent study.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kang Stem Biotech Co., Ltd.: lead

Study Sites (1)

Dongguk University Medical Center

Ilsan, South Korea

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Eundoek Yeo

CONTACT

82-2-888-1592; edyeo@kangstem.com

Seulbi Lee

CONTACT

82-2-888-1592; sblee@kangstem.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 29, 2021
• Study Start: March 27, 2022
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

KR (1)