Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
With
Sanofi
Age
12–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female ≥12 to \<18 years of age at time of screening visit
Diagnosis of AD according to the American Academy of Dermatology consensus criteria at screening visit
IGA ≥3 at screening and baseline visit
EASI ≥16 at the screening and baseline visit
Baseline Pruritus NRS average score for maximum itch intensity ≥4
≥10% BSA of AD involvement at the screening and baseline visits
With documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments is medically inadvisable
You may not be if
Participation in a prior dupilumab clinical study
Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit
Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
Body weight \<30 kg at baseline
Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit
Known or suspected immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit, established diagnosis of HBV infection or HBV seropositivity at screening, established diagnosis of HCV infection or HCV seropositivity at screening
History of malignancy before the baseline visit
Diagnosed active endoparasitic infections or at high risk of these infections
Patient is female who is pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Patient is female of childbearing potential and sexually active, who is unwilling to use adequate methods of contraception throughout the duration of the study and for 120 days after the last dose of study drug
Clareo Health | Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
