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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT03569293
Eligibility Criteria:
Inclusion Criteria:
* Body weight of ≥ 40 kg at Baseline Visit for participants between ≥ 12 and \< 18 years of age
* Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit and subject meets Hanifin and Rajka criteria.
* Active moderate to severe AD defined by:
* Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline Visits;
* Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and Baseline Visits;
* ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline Visits;
* Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
* Candidate for systemic therapy or have recently required systemic therapy for AD
* Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days before the Baseline Visit.
* Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit
Exclusion Criteria:
* Prior exposure to any Janus kinase (JAK) inhibitor
* Unable or unwilling to discontinue current atopic dermatitis treatments prior to the study
* Requirement of prohibited medications during the study
* Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
* Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
75 Years
Study:
NCT03569293
Study Brief:
Protocol Section:
NCT03569293