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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT04417894
Eligibility Criteria:
Key Inclusion Criteria:
* Patients with involvement of at least 2 anatomical areas at screening and baseline
* Patients need to have an IGA hand and foot score of 3 or 4 (moderate-to-severe disease) at screening and baseline
* Patients with documented recent history (within 6 months before the screening visit) of inadequate response of atopic hand and foot dermatitis to topical medication(s)
* Patients meet the diagnosis criteria for atopic dermatitis (AD)
* Provide informed consent/assent signed by study patient or legally acceptable representative
* Patients need to have been compliant with the skin protection measures through the entire duration of the screening period
Key Exclusion Criteria:
* Treatment with dupilumab in the past
* Patients with a positive patch test reaction that are deemed to be clinically relevant as the current cause of the hand and foot dermatitis
* Patients with documented exposure to irritants believed to be a predominant cause of the current hand and foot dermatitis
* Treatment with systemic corticosteroids or non-steroidal immunosuppressive drugs within 4 weeks prior to baseline
* Known history of HIV/HBV/HCV infection
* Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient's participation in this study
* Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and during the study
NOTE: Other protocol defined inclusion / exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04417894
Study Brief:
Protocol Section:
NCT04417894