Study of Growth and Bone Mineral Density in Children With Atopic Dermatitis (AD) Treated With Dupilumab
- Sponsor
- Regeneron Pharmaceuticals
- Study ID
- NCT07187089
- Phase
- PHASE4
- Status
- Withdrawn
Conditions
- Severe Atopic Dermatitis (AD)
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 11 Years
- Healthy Volunteers
- Not accepted
Interventions
- dupilumab — DRUGAdministered per the protocol
Study Details
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
Key Dates
- Start date
- Nov 11, 2025
- Status verified
- Nov 2025
- Primary completion
- Dec 23, 2027
- Completion
- Jan 5, 2028
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: dupilumab
Primary Outcome Measure
Improvement of ≥5 percentile in height-for-age percentile on the Centers for Disease Control and Prevention (CDC) growth chart [ Time Frame: Baseline to Week 52 ]