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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT05117060
Eligibility Criteria:
Inclusion Criteria:
* Adult, age 18 years or older at screening.
* Diagnosis of chronic atopic dermatitis (AD).
* History of AD ≥1 year prior to baseline.
* Recent (within 6 months prior to baseline) documented history of inadequate response to topical AD treatments or subject for whom topical AD treatments are medically inadvisable.
* 7.1≤ Eczema Area and Severity Index (EASI) ≤50 at baseline.
* Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score ≥3 at baseline.
Exclusion Criteria:
* Previous treatment with an oral histidine 4 receptor (H4R) antagonist (including LEO 152020) within 6 months prior to baseline.
* Previous treatment with 3 or more systemic AD treatments prior to screening.
* Women who are pregnant, intend to become pregnant, or are lactating.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05117060
Study Brief:
Protocol Section:
NCT05117060