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:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT04244006
Eligibility Criteria:
Inclusion Criteria:
* Adult patients affiliated to a social insurance protection regimen.
* Clinical diagnosis of NS (7) (trichorrhexis invaginata, extensive scaling, skin inflammation, allergic manifestations) and absent or marked reduction of LEKTI staining.
* Moderate to severe forms: NASA (Netherton Area Severity Assessment score) score ≥ 5/12 at inclusion.
* Patients able to understand the study procedures including the ability to complete patient-based self-assessment questionnaires.
* Patients who agree to sign the written informed consent.
Exclusion Criteria:
* Hypersensitivity to dupilumab or its excipients.
* Modification of the usual treatment (emollients and topical corticosteroids used on a regular basis) within 2 weeks before inclusion.
* Treatment with topical calcineurin inhibitors 1 week before inclusion.
* Treatment with oral immunosuppressant (including cyclosporine, methotrexate, azathioprine, mycophenolate mofetil), oral retinoids (acitretin, alitretinoin, isotretinoin) or phototherapy within 4 weeks before inclusion.
* Treatment with immunomodulating biologics (Tumor Necrosis Factor (TNF) inhibitor) 16 weeks before inclusion.
* Treatment with another investigational drug within 8 weeks before inclusion.
* Treatment with a systemic antibiotic within 2 weeks before inclusion.
* Active skin infection requiring the use of a systemic therapy within 2 weeks before the inclusion.
* Any other condition that according to the investigator will impair the ability to evaluate treatment effect.
* Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis).
* Current infections including infection with helminthes.
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study. Women of childbearing age, potentially sexually active, and unwilling to use adequate birth control methods.
* Mental or physical incapacity to fill in the questionnaires.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04244006
Study Brief:
Protocol Section:
NCT04244006