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ADSTEM InjNCT07377838

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

StatusRecruiting
PhasePhase 3
Primary completion (estimated)

At risk: Primary completion moved at least 2 months later.

See at-risk trials from EHL Bio Co., Ltd.

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 5 more changesShow less
    • Eligibility criteria expanded, about 30 words
    • Primary endpoints: details revised at 1 of 1 entry
    • Primary completion pushed from Jun 2029 to Sep 2029
    • Start date changed from estimate of Jun 2026 to Sep 15, 2026
    • Secondary endpoints: details revised at 3 of 13 entries
  2. Start date: Jan 2026 to Jun 2026v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

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)
Timeframe: From baseline to Weeks 16

Secondary (13)

Change from baseline (Visit 2) in vIGA score
Percentage of participants with a vIGA score reduction of 1 point or ≥2 points from baseline (Visit 2)
Percentage of participants with a vIGA score of 0 or 1 at Week 24
Percentage of participants with a ≥50% reduction in total EASI score from baseline (Visit 2)
Percentage of participants with a ≥75% reduction in total EASI score from baseline (Visit 2)
Show 8 moreShow less
Percentage of participants with a ≥90% reduction in total EASI score from baseline (Visit 2)
Change from baseline (Visit 2) in total EASI score
Percentage of participants with a ≥50% reduction in total SCORAD score from baseline (Visit 2)
Percentage of participants with a ≥75% reduction in total SCORAD score from baseline (Visit 2)
Change from baseline (Visit 2) in total SCORAD score
Change from baseline (Visit 2) in individual SCORAD item scores
Change from baseline (Visit 2) in DLQI score
Percentage of participants using rescue medication, number of uses, and total amount used

Arms and interventions

ADSTEM Inj.Experimental
PlaceboPlacebo comparator

Biologicals: ADSTEM Inj.

Drugs: Placebo

Sites

1 site in 1 country

  • Soonchunhyang University Cheonan HospitalCheonan, Chungcheongnam-do, South Korea