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Atopic DermatitisPhase 3NCT03269773

Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)

A Phase 3 study testing FURESTEM-AD Inj. in people with Atopic Dermatitis, run by Kang Stem Biotech Co., Ltd. at 11 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is multi-center, randomized, double-blind, parallel, placebo-controlled phase III 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
Atopic Dermatitis
What is being tested?
FURESTEM-AD Inj.
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
197 participants
Where
11 sitesSouth Korea
Study dates
25 Apr 2018to 20 Jun 2019
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

  • 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>=12 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)
  • 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
  • Any other condition which the investigator judges would make patient unsuitable for study participation

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

South Korea11 sites

  • Pusan National University Hospital

    Busan

  • Chonnam National University Hospital

    Gwangju

  • Dongguk University Medical Center

    Ilsan

  • Gachon University Gil Medical Center

    Incheon

  • Catholic Medical Center

    Seoul, 137-701

  • Asan Medical Center

    Seoul

  • Chung-Ang University Healthcare System

    Seoul

  • Hanyang University Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis

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

Being tested
FURESTEM-AD Inj., Placebo
Keywords
Atopic Dermatitis, Stem cell, Cell therapy, skin disease, Umbilical cord Blood, UCB-MSC, hUCB-MSC, AD, furestem, dermatitis, eczema
Medical subject headings
Dermatitis, Atopic, Skin Diseases, Dermatitis, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FURESTEM-AD Inj.Biological

    0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5 mL).

    Treatment group: FURESTEM-AD® inj. 5.0 X 107 cells/1.5 mL

  • PlaceboOther

    0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5mL)

Study groups in NCT03269773
Study groupRoleWhat they receive
FURESTEM-AD Inj.ExperimentalhUCB-MSC 5.0x10^7 cells
Receives: Biological: FURESTEM-AD Inj.
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

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

  1. over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)

    Measured: 12 week

Secondary outcomes (10)

  1. over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75)

    Measured: 12 week

  2. Change and rafe of change in EASI index

    Measured: 24weeks

  3. Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1

    Measured: 24weeks

  4. Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points

    Measured: 24weeks

  5. over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50)

    Measured: 24weeks

  6. Change and rafe of change in SCORAD index

    Measured: 24weeks

  7. Change and rafe of change in Body Surface Area (BSA)

    Measured: 24weeks

  8. Change in total serum Immunoglobulin E (IgE)

    Measured: 24weeks

  9. Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis)

    Measured: 24weeks

  10. Total number of use and consumed amount of rescue medicine

    Measured: 24weeks

Timeline

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

  1. First posted1 Sep 2017
  2. Study start25 Apr 2018
  3. Primary completion30 Mar 2019
  4. Study completion20 Jun 2019

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
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03269773
Sponsor's protocol ID
K0102
Status last verified
Sep 2019
First submitted
5 Oct 2016
Last updated
12 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FURESTEM-AD Inj. in people with Atopic Dermatitis, run by Kang Stem Biotech Co., Ltd. at 11 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 6 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: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50) (time frame: 12 week). 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 NCT03269773.

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 12 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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