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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT06224192
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 12 at Day 1.
* Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months.
* History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]).
* Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3 at screening and pre-randomization.
* Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening and pre-randomization.
* ≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization.
Exclusion Criteria:
* Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization.
* Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization:
1. Systemic corticosteroids
2. Non-biologic, non-targeted systemic immunosuppressants
3. Oral or Topical Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:
1. Topical phosphodiesterase 4 (PDE4) inhibitors
2. Other topical immunosuppressive agents (not including TCS/TCI)
3. Combination topical agents containing any of the above components
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
100 Years
Study:
NCT06224192
Study Brief:
Protocol Section:
NCT06224192