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Atopic DermatitisPhase 3ADSTEM InjNCT07377838

Study of ADSTEM Injection for Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

A Phase 3 study testing ADSTEM Inj. in people with Atopic Dermatitis, run by EHL Bio Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Study of ADSTEM Injection for Patients with Moderate to Severe Subacute and Chronic Atopic Dermatitis Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
ADSTEM Inj.
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
286 participants
Where
No sites listed yet
Study dates
Jun 2026to Dec 2029
Phase
Phase 3
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 19 to 70 years at the time of informed consent.
  • Diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria at screening.
  • History of atopic dermatitis for at least 24 weeks prior to screening.
  • Moderate-to-severe atopic dermatitis at screening, defined as:
  • EASI score ≥16
  • SCORAD score ≥25
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  • Body Surface Area (BSA) involvement ≥10%
  • vIGA score ≥3
  • Inadequate response to prior standard topical and/or systemic treatments for atopic dermatitis, or inability to receive such treatments due to safety concerns.
  • Voluntary written informed consent provided.

Who cannot join

  • Presence of clinically significant comorbidities at screening, including:
  • Active infection requiring antimicrobial treatment within 2 weeks prior to baseline, or superficial skin infection within 1 week prior to baseline;
  • Skin diseases that require ongoing treatment or may interfere with safety or efficacy assessments;
  • Uncontrolled asthma requiring oral corticosteroids;
  • Positive test results for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis;
  • Other uncontrolled or clinically significant medical conditions that may affect study participation or assessments;
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  • Clinically significant abnormal laboratory results at screening (e.g., AST or ALT > 3 × ULN, serum creatinine > 2 × ULN).
  • History of prohibited treatments prior to baseline, including:
  • Use of JAK inhibitors within 4 weeks;
  • Use of biologic therapies for atopic dermatitis within 12 weeks;
  • Use of systemic immunosuppressants, immunomodulators, or systemic corticosteroids within 4 weeks;
  • Use of topical corticosteroids, topical PDE-4 inhibitors, or topical calcineurin inhibitors within 2 weeks;
  • Participation in another clinical trial with an investigational drug or device within 4 weeks prior to screening;
  • Prior treatment with cell therapy or gene therapy.
  • History of malignancy within 5 years prior to screening, except adequately treated non-melanoma skin cancer without recurrence.
  • History of tanning within 4 weeks prior to baseline.
  • Pregnant or breastfeeding women, or women planning pregnancy during the study period.
  • Women of childbearing potential who are unwilling to use adequate contraception from the time of informed consent through the end of the study.
  • Known or suspected hypersensitivity to the investigational product or any of its components.
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of ADSTEM Inj. for Moderate to Severe Subacute and Chronic Atopic Dermatitis Patients

Study of ADSTEM Injection for Patients with Moderate to Severe Subacute and Chronic Atopic Dermatitis

Being tested
ADSTEM Inj., Placebo
Keywords
Adipose Derived Mesenchymal Stem cell, AD, Inflammatory disease, ADMSC, Stem cell, ehlbio
Medical subject headings
Dermatitis, Atopic

What participants receive

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

  • ADSTEM Inj.Biological

    hAD-MSC 1.0x10^8 cells

  • PlaceboDrug

    0.9% Normal Saline Inj.

Study groups in NCT07377838
Study groupRoleWhat they receive
ADSTEM Inj.ExperimentalNot described
Receives: Biological: ADSTEM Inj.
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of participants who achieve a score of 0 or 1 on the validated Investigator's Global Assessment (vIGA) scale at Visit 6, and demonstrate at least a 2-point reduction from baseline(Visit 2)

    validated Investigator's Global Assessment [vIGA], 0-4, higher scores indicate worse disease severity

    Measured: From baseline to Weeks 16

Secondary outcomes (13)

  1. Change from baseline (Visit 2) in vIGA score

    Measured: From baseline to Weeks 4, 8, 12, 16, 20, and 24

  2. Percentage of participants with a vIGA score reduction of 1 point or ≥2 points from baseline (Visit 2)

    Measured: From baseline to Weeks 4, 8, 12, 16, 20, and 24

  3. Percentage of participants with a vIGA score of 0 or 1 at Week 24

    Measured: From baseline to Week 24

  4. Percentage of participants with a ≥50% reduction in total EASI score from baseline (Visit 2)

    Eczema Area and Severity Index [EASI], 0-72, higher scores indicate worse disease severity

    Measured: From baseline to Weeks 4, 8, 12, 16, 20, and 24

  5. Percentage of participants with a ≥75% reduction in total EASI score from baseline (Visit 2)

    Measured: From baseline to Weeks 4, 8, 12, 16, 20, and 24

  6. Percentage of participants with a ≥90% reduction in total EASI score from baseline (Visit 2)

    Measured: From baseline to Weeks 4, 8, 12, 16, 20, and 24

  7. Change from baseline (Visit 2) in total EASI score

    Measured: From baseline to Weeks 4, 8, 12, 16, 20, and 24

  8. Percentage of participants with a ≥50% reduction in total SCORAD score from baseline (Visit 2)

    Scoring Atopic Dermatitis [SCORAD], 0-103, higher scores indicate worse disease severity

    Measured: From baseline to Weeks 4, 8, 12, 16, 20, and 24

  9. Percentage of participants with a ≥75% reduction in total SCORAD score from baseline (Visit 2)

    Measured: From baseline to Weeks 4, 8, 12, 16, 20, and 24

  10. Change from baseline (Visit 2) in total SCORAD score

    Measured: From baseline to Weeks 4, 8, 12, 16, 20, and 24

  11. Change from baseline (Visit 2) in individual SCORAD item scores

    Measured: From baseline to Weeks 4, 8, 12, 16, 20, and 24

  12. Change from baseline (Visit 2) in DLQI score

    Dermatology Life Quality Index [DLQI], 0-30, higher scores indicate worse quality of life

    Measured: From baseline to Weeks 8, 16, and 24

  13. Percentage of participants using rescue medication, number of uses, and total amount used

    Measured: From Week -6 (Visit 1) to Weeks 4, 8, 12, 16, 20, and 24

Timeline

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

  1. First posted30 Jan 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2029 (estimated)
  4. Study completionDec 2029 (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
286 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07377838
Sponsor's protocol ID
AD-CP-23-1
Acronym
ADSTEM Inj
Status last verified
Feb 2026
First submitted
22 Jan 2026
Last updated
12 Feb 2026
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 ADSTEM Inj. in people with Atopic Dermatitis, run by EHL Bio Co., Ltd..

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 10 inclusion and 20 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

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?

Percentage of participants who achieve a score of 0 or 1 on the validated Investigator's Global Assessment (vIGA) scale at Visit 6, and demonstrate at least a 2-point reduction from baseline(Visit 2) (time frame: From baseline to Weeks 16). 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 NCT07377838.

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 Feb 2026.

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