Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT06775860
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects between 18 and 75 years of age.
2. Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year
3. Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.
4. 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.
5. Women of childbearing potential (WOCBP) and Men must agree
5\. 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.
Exclusion Criteria:
1. Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.
2. Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
3. Pregnant or breastfeeding females.
4. History of any clinically major diseases, with the exception of atopic dermatitis.
5. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06775860
Study Brief:
Protocol Section:
NCT06775860