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

January 25, 2021 updated by: Kang Stem Biotech Co., Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
Time Frame: for 5 years
for 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kang Stem Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 27, 2022

Primary Completion (Anticipated)

June 30, 2030

Study Completion (Anticipated)

June 30, 2030

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 29, 2021

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K0104-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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