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Dermatitis, AtopicPhase 3smart(FURIN)NCT05004324

Safety and Efficacy of FURESTEM-AD Inj. for Moderate to Severe Atopic Dermatitis (AD)

A Phase 3 study testing FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL in people with Dermatitis, Atopic, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This clinical trial study is two-stage, multi-center, randomized, double-blind, placebo controlled, phase 3 clinical trial to evaluate the efficacy and safety 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
Dermatitis, Atopic
What is being tested?
FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
308 participants
Where
1 siteSouth Korea
Study dates
29 Jun 2021to Apr 2023
Phase
Phase 3
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

  • Adults aged 19 years and older at time of informed consent
  • Subjects diagnosed with atopic dermatitis based on the Hanifin and Rajka diagnostic criteria
  • Subjects with chronic atopic dermatitis that has been present for at least 1 year before screening
  • Subjects with moderate to severe atopic dermatitis as indicated by:
  • EASI score ≥ 16 points at the time of screening and baseline (Day 1),
  • IGA score ≥ 3 points at the time of screening and baseline (Day 1), and
Show all 11Show fewer
  • BSA affected by atopic dermatitis ≥ 10% at the time of screening and baseline (Day 1)
  • Subjects who have documented history of insufficient response to stable use of atopic dermatitis treatment within 24 weeks before screening, or inability to receive such treatment because of safety issues
  • Subjects who are willing to apply a stable dose of non-medicated topical moisturizer at least twice daily for at least 7 days before the baseline (Day 1) visit and the duration of the study
  • Women of childbearing potential who use appropriate contraceptive methods during this trial period
  • Subjects who have voluntarily agreed to participate in this trial in writing

Who cannot join

  • Subjects with the following history of disease or surgery/procedure at screening
  • Malignancy or lympho-proliferative disease within 5 years before screening (except completely treated carcinoma in situ of the cervix, or completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin)
  • organ transplants
  • History of mental illness, drug or alcohol abuse within 2 years before screening, as per Investigator's opinion
  • Subjects with the following underlying disease at screening
  • Chronic active, acute infection or superficial skin infections requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals or antifungals;
Show all 25Show fewer
  • Skin diseases, pigmentation, or extensive scarring other than atopic dermatitis that may affect the efficacy evaluations of the study
  • Renal dysfunction with serum creatinine level > 2.0 mg/dL at screening
  • Liver dysfunction with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 2.5 times the upper limit of the normal range (ULN) at the time of screening
  • Subjects with the history of using leukotriene receptor antagonists, systemic steroids, phototherapy, systemic immunosuppressants/modulators including janus kinase (JAK) inhibitors, and/or any other systemic therapy (not mentioned in Exclusion Criteria 6 and 8) to treat atopic dermatitis or symptoms of atopic dermatitis (approved or off-label use) within 4 weeks before baseline (Day 1)
  • Subjects with the history of using systemic or topical antihistamines, topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs), or topical phosphodiesterase 4 (PDE4) inhibitors within 2 weeks before baseline (Day 1)
  • Allergen immunotherapy within 6 months before baseline (Day 1)
  • Subjects with the history of receipt of the following treatments before baseline (Day 1)
  • B cell-depleting agents including rituximab within 6 months
  • Other biologics including dupilumab within 5 half-lives (if known) or 12 weeks, whichever is longer
  • Subjects with regular use (more than two times per a week) of a tanning booth/parlor within 4 weeks before screening visit
  • Subjects with the history of a live (attenuated) vaccine injection within 12 weeks before baseline (Day 1) or the plan to inject a live (attenuated) vaccine within 24 weeks after randomization
  • Subjects who are deemed to require prohibited concomitant medications drug/therapy during the study period
  • Subjects with uncontrolled chronic disease that might require administration of oral corticosteroids such as uncontrolled and severe asthma
  • Pregnant/lactating women and men and women of childbearing potential who plan to become pregnant or who refuse to use appropriate contraceptive methods during the study period
  • Subjects with the history of receipt of any investigational products or devices from another clinical trial within 4 weeks or 5 half-lives (if known) pior to screening
  • Positive serology for hepatitis B or C, or for HIV
  • Subjects with prior use of FURESTEM-AD
  • Subjects with history of anaphylaxis
  • Subjects who are deemed to have difficulty in performing this study by the judgment of the Investigator and those with other medical findings that are unsuitable for participation in the study

Trial locations and contacts

1 site in 1 country.

Noori Kim contact

2-888-1590 ext. 82

nrkim@kangstem.com

Seulbi Lee contact

2-888-1590 ext. 82

sblee@kangstem.com

South Korea1 site, 1 recruiting

  • Chosun University Hospital

    Gwangju, Jeollanam-do, 61453

    Chanho Na, professor

    Recruiting

Other trials in South Korea

About this study

Official title: A Two-stage, Multi-center, Randomized, Double-Blind, Placebo Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis

This clinical trial study is two-stage, multi-center, randomized, double-blind, placebo controlled, phase 3 clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic atopic dermatitis.

Being tested
FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL, Placebo
Keywords
Atopic Dermatitis, AD, Stem cell, Furestem
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® inj. 5.0 X 10^7 cells/1.5 mLBiological

    the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)

  • PlaceboBiological

    the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)

Study groups in NCT05004324
Study groupRoleWhat they receive
Furestem-AD Inj.ExperimentalInvestigational product name: FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL baseline (0week) Experimental group will receive Investigational product (FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL). After 12 weeks, Experimental group will receive placebo.
Receives: Biological: FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL; Biological: Placebo
PlaceboPlacebo comparatorPlacebo baseline (0week) Placebo comparator group will receive placebo. After 12 weeks, Placebo comparator group will receive Investigational product (FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL).
Receives: Biological: FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EASI(Eczema Area and Severity Index)-50

    Ratio of subject whose Eczema Area and Severity Index (EASI) decreased over 50% as contrasted with baseline value

    Measured: 12 weeks

Secondary outcomes (13)

  1. EASI(Eczema Area and Severity Index)-75

    Ratio of subjects whose Eczema Area and Severity Index (EASI) decreased over 75% as contrasted with baseline value

    Measured: 2,4,8,12 weeks

  2. EASI(Eczema Area and Severity Index)-50

    Ratio of subjects whose Eczema Area and Severity Index (EASI) decreased over 50% as contrasted with baseline value

    Measured: 2,4,8 weeks

  3. EASI(Eczema Area and Severity Index) index

    Change and rate of change in Eczema Area and Severity Index (EASI) index as contrasted with baseline value

    Measured: 2,4,8,12 weeks

  4. IGA(Investigator's Global Assessment) Score

    Proportion of subjects who Investigator's Global Assessment (IGA) score 0 or 1 and at least 2 points reduction in IGA score as contrasted with baseline value

    Measured: 2,4,8,12 weeks

  5. SCORAD(SCORing Atopic Dermatitis)-50

    Ratio of subjects whose SCORing Atopic Dermatitis (SCORAD) decreased over 50% as contrasted with baseline value

    Measured: 2,4,8,12 weeks

  6. SCORAD(SCORing Atopic Dermatitis) index

    Change and rate of change in SCORing Atopic Dermatitis (SCORAD) index as contrasted with baseline value

    Measured: 2,4,8,12 weeks

  7. BSA(Body Surface Area)

    Change and rate of change in Body Surface Area (BSA) as contrasted with baseline value

    Measured: 2,4,8,12 weeks

  8. Worst daily Pruritus NRS(Numerical Rating Scale)

    Rate of change in Worst daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value

    Measured: 2,4,8,12 weeks

  9. Average daily Pruritus NRS(Numerical Rating Scale)

    Rate of change in Average daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value

    Measured: 2,4,8,12 weeks

  10. Worst daily Pruritus NRS(Numerical Rating Scale) - 4 points

    Proportion of patients at least 4 points reduction in Worst daily Pruritus Numerical Rating Scale (NRS) as contrasted with baseline value

    Measured: 2,4,8,12 weeks

  11. POEM(Patient-Oriented Eczema Measure)

    Change and rate of change in Patient-Oriented Eczema Measure (POEM) as contrasted with baseline value

    Measured: 2,4,8,12 weeks

  12. DLQI(Dermatology Life Quality Index)

    Change and rate of change in Dermatology Life Quality Index (DLQI) as contrasted with baseline value

    Measured: 2,4,8,12 weeks

  13. Rescue medicine

    Total number of use and consumed amount of rescue medicine

    Measured: up to 12, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2021
  2. Study start29 Jun 2021
  3. Primary completionJan 2023 (estimated)
  4. Study completionApr 2023 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
308 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05004324
Sponsor's protocol ID
K0106
Acronym
smart(FURIN)
Status last verified
Jul 2021
First submitted
4 Jul 2021
Last updated
13 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL in people with Dermatitis, Atopic, 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 11 inclusion and 25 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 13 Aug 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. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Noori Kim (2-888-1590 ext. 82, nrkim@kangstem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EASI(Eczema Area and Severity Index)-50 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05004324.

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 13 Aug 2021.

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