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

Korábbi kezelés

• 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 tanning within 4 weeks prior to baseline.
• Known or suspected hypersensitivity to the investigational product or any of its components.

Más betegség

• History of malignancy within 5 years prior to screening, except adequately treated non-melanoma skin cancer without recurrence.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.

Laborértékek

• 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).

Egyéb

• 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.

• 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.