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 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT03517566
Eligibility Criteria:
Inclusion Criteria:
* Subjects must give a written, signed and dated informed consent
* Chronic atopic dermatitis present for at least 1 year before Baseline
* Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.
* Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
* Candidate for systemic treatment
Exclusion Criteria:
* Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity
* Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
* History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes.
* Participation in prior ZPL389 studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03517566
Study Brief:
Protocol Section:
NCT03517566