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:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT04212169
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 65 years inclusive at the time of consent.
* Body mass index between 19.0 and 40.0 kg/m2 inclusive.
* Documented history of chronic AD, for at least 1 year prior to screening Visit 1.
* Meets at minimum 1 of the criteria, as follows:
* History of inadequate response to topical medications for AD
* Subject intolerance to treatment with topical medications for AD, or
* Topical medications are otherwise medically inadvisable
* AD that affects ≥ 10% of the body surface area (BSA).
* An EASI score of ≥ 12 at Visit 1 and ≥ 16 at Visit 3 (Day 1).
* An IGA score of ≥ 3.
Exclusion Criteria:
* Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
* Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram \[ECG\]) or from safety laboratory analysis.
* Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.
* Known active allergic or irritant contact dermatitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04212169
Study Brief:
Protocol Section:
NCT04212169