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

NCT07377838 | Not Yet Recruiting Phase 3

• 1 other identifier: AD-CP-23-1
• Study Type: interventional
• Target: 286
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atopic Dermatitis

Keywords

Adipose Derived Mesenchymal Stem cell; AD; Inflammatory disease; ADMSC; Stem cell; ehlbio

Outcome Measures

Primary Outcomes (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

  From baseline to Weeks 16

Secondary Outcomes (13)

• 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)

  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

Study Arms (2)

ADSTEM Inj.

EXPERIMENTAL

Biological: ADSTEM Inj.

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

0.9% Normal Saline Inj.

Placebo

ADSTEM Inj. BIOLOGICAL

hAD-MSC 1.0x10\^8 cells

ADSTEM Inj.

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• EHL Bio Co., Ltd.: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share