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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04730024
Recruitment Status : Not yet recruiting
First Posted : January 29, 2021
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Kang Stem Biotech Co., Ltd.

Study Description
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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

Condition or disease Intervention/treatment
Atopic Dermatitis Other: Not applicable(observational study)

Study Design
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Study Type : Observational
Estimated Enrollment : 102 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Estimated Study Start Date : March 27, 2022
Estimated Primary Completion Date : June 30, 2030
Estimated Study Completion Date : June 30, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Groups and Cohorts
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Intervention Details:
  • Other: Not applicable(observational study)
    Not applicable(observational study)

Outcome Measures
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Primary Outcome Measures :
  1. Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event) [ Time Frame: for 5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Rate of change and Change in EASI from baseline [ Time Frame: for 5 years ]
    EASI range is from 0 (clear) to 72 (severe)

  4. Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1 [ Time Frame: for 5 years ]
  5. Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher [ Time Frame: for 5 years ]
  6. 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 ]
  7. 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)

  8. Change and rate of change in Body Surface Area (BSA) [ Time Frame: for 5 years ]
  9. Change and rate of change in total serum Immunoglobulin E (IgE) [ Time Frame: for 5 years ]
  10. Change and rate of change DLQI [ Time Frame: for 5 years ]
  11. Change and rate of change POEM [ Time Frame: for 5 years ]
  12. Change and rate of change Peak Pruritus NRS [ Time Frame: for 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730024


Contacts
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Contact: Eundoek Yeo 82-2-888-1592 edyeo@kangstem.com
Contact: Seulbi Lee 82-2-888-1592 sblee@kangstem.com

Locations
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Korea, Republic of
Dongguk University Medical Center
Ilsan, Korea, Republic of
Sponsors and Collaborators
Kang Stem Biotech Co., Ltd.
More Information
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Responsible Party: Kang Stem Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04730024    
Other Study ID Numbers: K0104-E
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases