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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT03050151
Eligibility Criteria:
Key Inclusion Criteria:
1. Diagnosis of chronic atopic dermatitis for at least 3 years with inadequate response to topical medications within 6 months before screening
2. Willing and able to comply with all clinic visits and study-related procedures
3. Provide signed informed consent
Key Exclusion Criteria:
1. Patient \< 30.0 kilograms (Kg) in weight
2. Patient who has previously participated in a dupilumab clinical study
3. Patient who has been treated with the following:
* An investigational drug within 8 weeks or within 5 half-lives (if known),whichever is longer, before the baseline visit
* Immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mufti, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.) or Phototherapy for AD within 4 weeks before the baseline visit
* An experimental monoclonal antibody within 5 half-lives or within 6◦months prior to visit 1 if the half-life is unknown
* Biologic agents within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer
* Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to visit 1
* A live (attenuated) vaccine within 4 weeks before the baseline visit
4. Patient who has initiated treatment with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
5. Patient who has skin comorbidities that may interfere with study assessments
6. Patient with a planned or anticipated major surgical procedure during the patient's participation in this study
7. Women of childbearing potential unwilling to use adequate birth control measures during the study
8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03050151
Study Brief:
Protocol Section:
NCT03050151