Atopic DermatitisNCT04730024
Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj
An observational study of Atopic Dermatitis, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Not applicable(observational study)
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Mar 2022to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study (K0104-E), it was planned to select subjects who participated in the K0104 clinical trial, a parent study.
Who may be able to join
- Subject who enrolled K0104 Clinical Trial(parent study).
- Subjects who understand and voluntarily sign an informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Not applicable(observational study)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable(observational study)Other
Not applicable(observational study)
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
Measured: 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)
Measured: 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)
Measured: for 5 years
Rate of change and Change in EASI from baseline
EASI range is from 0 (clear) to 72 (severe)
Measured: for 5 years
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
Measured: for 5 years
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
Measured: 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)
Measured: for 5 years
Rate of change and Change in SCORAD index from baseline at each visit
SCORAD index range is from 0 (clear) to 103 (severe)
Measured: for 5 years
Change and rate of change in Body Surface Area (BSA)
Measured: for 5 years
Change and rate of change in total serum Immunoglobulin E (IgE)
Measured: for 5 years
Change and rate of change DLQI
Measured: for 5 years
Change and rate of change POEM
Measured: for 5 years
Change and rate of change Peak Pruritus NRS
Measured: for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start27 Mar 2022 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kang Stem Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730024
- Sponsor's protocol ID
- K0104-E
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04730024
- Acronym / sponsor ID
- K0104-E
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2022 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study (K0104-E), it was planned to select subjects who participated in the K0104 clinical trial, a parent study.
Key inclusion criteria (2 listed)
- Subject who enrolled K0104 Clinical Trial(parent study).
- Subjects who understand and voluntarily sign an informed consent form
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable(observational study)Not applicable(observational study) | Other | – |
Primary outcome
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)
Time frame: for 5 years
12 secondary outcomes
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
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
Rate of change and Change in EASI from baseline
Time frame: 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
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
Time frame: 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
Rate of change and Change in SCORAD index from baseline at each visit
Time frame: for 5 years
Change and rate of change in Body Surface Area (BSA)
Time frame: for 5 years
Change and rate of change in total serum Immunoglobulin E (IgE)
Time frame: for 5 years
Change and rate of change DLQI
Time frame: for 5 years
Change and rate of change POEM
Time frame: for 5 years
Change and rate of change Peak Pruritus NRS
Time frame: for 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eundoek Yeo (82-2-888-1592, edyeo@kangstem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event) (time frame: for 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.