This study is researching an approved drug called dupilumab (called "study drug"). Dupilumab is approved in the United States for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (also commonly known as eczema). The aim of the study is to see if dupilumab treatment of children with severe atopic dermatitis, which cannot be adequately controlled with topical atopic dermatitis medication, improves growth and bone strength. The study is looking at other research questions, including: • What side effects may happen from taking dupilumab
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Administered per the protocol
Improvement of ≥5 percentile in height-for-age percentile on the Centers for Disease Control and Prevention (CDC) growth chart
The Centers for Disease Control and Prevention (CDC) growth charts use percentile scales as a measurement system. The percentile scale is a ranking system that compares a child's growth measurements (e.g., height, weight, Body Mass Index \[BMI\]) to a reference population of the same age and sex.
Time frame: Baseline to Week 52
Change from baseline in Lumbar Spine (LS) Bone Mineral Density (BMD) adjusted Z-score measured by Dual-Energy X-Ray Absorptiometry (DEXA)
Time frame: Baseline to Week 52
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through Week 54
Occurrence of Serious Adverse Events (SAEs)
Time frame: Through Week 54
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.