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Withdrawn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 — DRUG
    Administered 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 ]