ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis

Korábbi kezelés

• Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.

Más betegség

• Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
• History of any clinically major diseases, with the exception of atopic dermatitis.

Egyéb

• Pregnant or breastfeeding females.
• Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.

• Male or female subjects between 18 and 75 years of age.
• Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year
• Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.
• Subjects must meet the following criteria for disease activity:
  • Eczema Area and Severity Index (EASI) score ≥ 16 ;
  • (Body Surface Area )BSA affected by AD ≥ 10% ;
  • (validated Investigator's Global Assessment-AD)vIGA-AD score ≥3 ;
  • Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
• Women of childbearing potential (WOCBP) and Men must agree
• Women of childbearing potential (WOCBP) and Men must agree to contraception. 6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.