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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Biological: ADSTEM Inj.; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 286
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged 19 to 70 years at the time of informed consent.
2. Diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria at screening.
3. History of atopic dermatitis for at least 24 weeks prior to screening.

4. Moderate-to-severe atopic dermatitis at screening, defined as:

   • EASI score ≥16
   • SCORAD score ≥25
   • Body Surface Area (BSA) involvement ≥10%
   • vIGA score ≥3
5. Inadequate response to prior standard topical and/or systemic treatments for atopic dermatitis, or inability to receive such treatments due to safety concerns.
6. Voluntary written informed consent provided.

Exclusion Criteria:

1. 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;
   • Clinically significant abnormal laboratory results at screening (e.g., AST or ALT > 3 × ULN, serum creatinine > 2 × ULN).

2. 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.
3. History of malignancy within 5 years prior to screening, except adequately treated non-melanoma skin cancer without recurrence.
4. History of tanning within 4 weeks prior to baseline.
5. Pregnant or breastfeeding women, or women planning pregnancy during the study period.
6. Women of childbearing potential who are unwilling to use adequate contraception from the time of informed consent through the end of the study.
7. Known or suspected hypersensitivity to the investigational product or any of its components.
8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 0.9% Normal Saline Inj.
Experimental: ADSTEM Inj.	Biological: ADSTEM Inj.; hAD-MSC 1.0x10^8 cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From baseline to Weeks 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline (Visit 2) in vIGA score		From baseline to Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with a vIGA score reduction of 1 point or ≥2 points from baseline (Visit 2)		From baseline to Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with a vIGA score of 0 or 1 at Week 24		From baseline to Week 24
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	From baseline to Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with a ≥75% reduction in total EASI score from baseline (Visit 2)		From baseline to Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with a ≥90% reduction in total EASI score from baseline (Visit 2)		From baseline to Weeks 4, 8, 12, 16, 20, and 24
Change from baseline (Visit 2) in total EASI score		From baseline to Weeks 4, 8, 12, 16, 20, and 24
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	From baseline to Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with a ≥75% reduction in total SCORAD score from baseline (Visit 2)		From baseline to Weeks 4, 8, 12, 16, 20, and 24
Change from baseline (Visit 2) in total SCORAD score		From baseline to Weeks 4, 8, 12, 16, 20, and 24
Change from baseline (Visit 2) in individual SCORAD item scores		From baseline to Weeks 4, 8, 12, 16, 20, and 24
Change from baseline (Visit 2) in DLQI score	Dermatology Life Quality Index [DLQI], 0-30, higher scores indicate worse quality of life	From baseline to Weeks 8, 16, and 24
Percentage of participants using rescue medication, number of uses, and total amount used		From Week -6 (Visit 1) to Weeks 4, 8, 12, 16, 20, and 24

Collaborators and Investigators

• Sponsor: EHL Bio Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: AD; Stem cell; Inflammatory disease; Adipose Derived Mesenchymal Stem cell; ADMSC; ehlbio
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: AD-CP-23-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No