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

Sponsor
EHL Bio Co., Ltd.
Study ID
NCT07377838
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ADSTEM Inj. — BIOLOGICAL
    hAD-MSC 1.0x10\^8 cells
  • Placebo — DRUG
    0.9% Normal Saline Inj.

Study Details

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

Key Dates

First listed
Jan 30, 2026
Start date
Jun 30, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
286 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ADSTEM Inj.
  • Placebo Comparator: Placebo

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 ]

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