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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT05388760
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
* Age 6 to \<12 years at time of the baseline visit.
* Body weight at baseline of ≥17 kg.
* History of AD for ≥ 12 months at screening.
* History of TCS and/or TCI treatment failure (due to inadequate response or intolerance) or subjects for whom these topical AD treatments are medically inadvisable.
* AD involvement of ≥10% body surface area at screening and baseline.
* An EASI score of ≥16 at screening and at baseline.
* An Investigator's Global Assessment (IGA) score of ≥3 at screening and at baseline.
* Emollient twice daily (or more) for at least 14 days prior to baseline.
Exclusion Criteria:
* Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
* Treatment with topical PDE-4 inhibitor within 2 weeks prior to randomization.
* Treatment with the following immunomodulatory medications or bleach baths within 4 weeks prior to baseline:
* Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors).
* Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or intranasal delivery).
* 3 or more bleach baths during any week within the 4 weeks.
* Receipt of any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, or dupilumab):
* Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
* Other biologics (including dupilumab): within 3 months or 5 halflives, whichever is longer, prior to baseline.
* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, or antiprotozoals within 2 weeks before the baseline visit.
* History of malignancy at any time before the baseline visit.
* History of anaphylaxis following any biological therapy.
* History of immune complex disease.
* Active or suspected endoparasitic infections.
* History of past or current tuberculosis or other mycobacterial infection.
* Established diagnosis of a primary immunodeficiency disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
11 Years
Study:
NCT05388760
Study Brief:
Protocol Section:
NCT05388760