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NCT Number: NCT04730024

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

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

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongguk University Medical Center

Ilsan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Not applicable(observational study)

Other

Not applicable(observational study)

Primary outcomes

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

    Time frame: for 5 years

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Eundoek Yeo

CONTACT

[email protected]

82-2-888-1592

Seulbi Lee

CONTACT

[email protected]

82-2-888-1592

Sponsors and collaborators

Lead sponsor

Kang Stem Biotech Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Jan 29, 2021
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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