Atopic DermatitisPhase 1/2NCT04725136
Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis
A Phase 1/2 study testing FURESTEM-AD inj in people with Atopic Dermatitis, run by Kang Stem Biotech Co., Ltd. at 2 sites in South Korea.
Trial summary
A Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis 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?
- FURESTEM-AD inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 27 Jan 2021to 31 May 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
Who may be able to join
- Of either gender, aged >=19
- Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
- Chronic Atopic Dermatitis that has been present for at least 3 years
- EASI>=16 at screening and baseline visit
- IGA>=3, SCORAD index>=25, BSA >=10% of AD involvement at screegning and baseline visit
- Subjects with documented record of inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks before participating in the study, or whom are inadvisable due to safety risks
- Subjects who understand and voluntarily sign an informed consent form
Who cannot join
- Subjects with medical history or surgery/procedure history
- Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region)
- Renal dysfunction with creatinine >2.0 mg/dL at screening
- Hepatic dysfunction with ALT or AST levels 2.5 times higher than the normal range at screening
- ALC<800/mm3 at screening
- Subjects with live vaccine administration within 12 weeks before baseline
Show all 13Show fewer
- Receipt of leukotriene receptor antagonists, systemic steroids, systemic or topical antihistamines, phototherapy, or systemic immunosuppressants/modulators including janus kinase (JAK) inhibitors, and/or any other systemic therapy within 4 weeks before Baseline
- Receipt of topical steroids(class1~6), topical tacrolimus or pimecrolimus within 2 weeks before Baseline
- Subjects who need prohibited medication during clinical period
- Pregnant, breast-feeding women or women who plan to become pregnant during this study
- Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
- Subjects with experience of administering FURESTEM-AD inj.
- Any other condition which the investigator judges would make patient unsuitable for study participation
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 1 recruiting
- Completed
Dongguk University Medical Center
Ilsan
- Recruiting
Seoul National Hospital
Seoul
Donghoon Lee, Professor
About this study
Official title: A Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis
A Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis
Read the detailed description
Phase 1: Multicenter, repeated administration, disclosure, dose escalation, Evaluate safety and tolerability and explore efficacy
Phase 2a: Multicenter, repeated administration, random assignment, double blinding, parallel, Efficacy and safety are evaluated for repeated administration compared to placebo and single administration.
- Conditions
- Atopic Dermatitis
- Being tested
- FURESTEM-AD inj
- Keywords
- hUCB-MSC, Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FURESTEM-AD injBiological
Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.
| Study group | Role | What they receive |
|---|---|---|
| High-dose repeat administration group | Experimental | FURESTEM-AD Inj 1.0 x 10^8 cells /body 3 repeated subcutaneous injection at 4 week intervals Receives: Biological: FURESTEM-AD inj |
| High-dose single administration group | Experimental | FURESTEM-AD Inj 1.0 x 10^8 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals Receives: Biological: FURESTEM-AD inj |
| Low-dose repeat administration group | Experimental | FURESTEM-AD Inj 5.0 x 10^7 cells /body 3 repeated subcutaneous injection at 4 week intervals Receives: Biological: FURESTEM-AD inj |
| Low-dose single administration group | Experimental | FURESTEM-AD Inj 5.0 x 10^7 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals Receives: Biological: FURESTEM-AD inj |
| Placebo | Placebo comparator | Normal saline(0.9% NaCl) 3 repeated subcutaneous injection at 4 week intervals Receives: Biological: FURESTEM-AD inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment
safety information including drug tolerability
Measured: 24 weeks follow-up after first treatment
Secondary outcomes (15)
Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)
Measured: 24 weeks follow-up after first treatment
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)
Measured: 24 weeks follow-up after first treatment
Rate of change and Change in EASI from baseline
EASI range is from 0 (clear) to 72 (severe)
Measured: 24 weeks follow-up after first treatment
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
IGA score is from 0 (clear) to 5 (severe)
Measured: 24 weeks follow-up after first treatment
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
IGA score is from 0 (clear) to 5 (severe)
Measured: 24 weeks follow-up after first treatment
Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)
Measured: 24 weeks follow-up after first treatment
Rate of change and Change in SCORAD index from baseline at each visit
SCORAD index range is from 0 (clear) to 103 (severe)
Measured: 24 weeks follow-up after first treatment
Change and rate of change in Body Surface Area (BSA)
Measured: 24 weeks follow-up after first treatment
Change and rate of change in total serum Immunoglobulin E (IgE)
Measured: 24 weeks follow-up after first treatment
Change and rate of change in Cytokine
CCL17(TARC), CCL18(PARC), CCL26(eotaxin-3), CCL27(CTACK), IL-4, IL-17A, IL-22, SCCA2
Measured: 24 weeks follow-up after first treatment
Change and rate of change DLQI
Measured: 24 weeks follow-up after first treatment
Change and rate of change POEM
Measured: 24 weeks follow-up after first treatment
Change and rate of change Peak Pruritus NRS
Measured: 24 weeks follow-up after first treatment
Change and rate of change eosinophil
Measured: 24 weeks follow-up after first treatment
Use the number and total amount of rescue
only Phase 2a
Measured: 24 weeks follow-up after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start27 Jan 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion31 May 2023 (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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 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
- NCT04725136
- Sponsor's protocol ID
- K0104
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04725136
- Acronym / sponsor ID
- K0104
- Conditions
- Atopic Dermatitis
- Keywords
- hUCB-MSC, Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 26 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 Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis
Detailed description
Phase 1: Multicenter, repeated administration, disclosure, dose escalation, Evaluate safety and tolerability and explore efficacy
Phase 2a: Multicenter, repeated administration, random assignment, double blinding, parallel, Efficacy and safety are evaluated for repeated administration compared to placebo and single administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| High-dose repeat administration group | Experimental | Biological: FURESTEM-AD injFURESTEM-AD Inj 1.0 x 10^8 cells /body 3 repeated subcutaneous injection at 4 week intervals |
| High-dose single administration group | Experimental | Biological: FURESTEM-AD injFURESTEM-AD Inj 1.0 x 10^8 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals |
| Low-dose repeat administration group | Experimental | Biological: FURESTEM-AD injFURESTEM-AD Inj 5.0 x 10^7 cells /body 3 repeated subcutaneous injection at 4 week intervals |
| Low-dose single administration group | Experimental | Biological: FURESTEM-AD injFURESTEM-AD Inj 5.0 x 10^7 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals |
| Placebo | Placebo comparator | Biological: FURESTEM-AD injNormal saline(0.9% NaCl) 3 repeated subcutaneous injection at 4 week intervals |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Of either gender, aged >=19
- Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
- Chronic Atopic Dermatitis that has been present for at least 3 years
- EASI>=16 at screening and baseline visit
- IGA>=3, SCORAD index>=25, BSA >=10% of AD involvement at screegning and baseline visit
Key exclusion criteria (13 listed)
- Subjects with medical history or surgery/procedure history
- Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region)
- Renal dysfunction with creatinine >2.0 mg/dL at screening
- Hepatic dysfunction with ALT or AST levels 2.5 times higher than the normal range at screening
- ALC<800/mm3 at screening
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 |
|---|---|---|
| FURESTEM-AD injRepeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals. | Biological | High-dose repeat administration group, High-dose single administration group, Low-dose repeat administration group, Low-dose single administration group, Placebo |
Primary outcome
Safety Assessment
Time frame: 24 weeks follow-up after first treatment
safety information including drug tolerability
15 secondary outcomes
Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)
Time frame: 24 weeks follow-up after first treatment
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: 24 weeks follow-up after first treatment
Rate of change and Change in EASI from baseline
Time frame: 24 weeks follow-up after first treatment
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
Time frame: 24 weeks follow-up after first treatment
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
Time frame: 24 weeks follow-up after first treatment
Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)
Time frame: 24 weeks follow-up after first treatment
Rate of change and Change in SCORAD index from baseline at each visit
Time frame: 24 weeks follow-up after first treatment
Change and rate of change in Body Surface Area (BSA)
Time frame: 24 weeks follow-up after first treatment
Change and rate of change in total serum Immunoglobulin E (IgE)
Time frame: 24 weeks follow-up after first treatment
Change and rate of change in Cytokine
Time frame: 24 weeks follow-up after first treatment
Change and rate of change DLQI
Time frame: 24 weeks follow-up after first treatment
Change and rate of change POEM
Time frame: 24 weeks follow-up after first treatment
Change and rate of change Peak Pruritus NRS
Time frame: 24 weeks follow-up after first treatment
Change and rate of change eosinophil
Time frame: 24 weeks follow-up after first treatment
Use the number and total amount of rescue
Time frame: 24 weeks follow-up after first treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- 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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FURESTEM-AD inj in people with Atopic Dermatitis, run by Kang Stem Biotech Co., Ltd. at 2 sites 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 7 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eundeok 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 (time frame: 24 weeks follow-up after first treatment). 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 11 Jan 2022.