Status:
WITHDRAWN
Study of Growth and Bone Mineral Density in Children With Atopic Dermatitis (AD) Treated With Dupilumab
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Severe Atopic Dermatitis (AD)
Eligibility:
All Genders
6-11 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Key
- Children with body weight ≥15 kg and \<60 kg at screening visit 1
- Diagnosis of AD according to American Academy of Dermatology consensus criteria at time of screening visit
- Investigator Global Assessment (IGA) score = 4 at screening and baseline visits
- ≥15% Body Surface Area (BSA) of AD involvement at the screening and baseline visits
- Worst Itch Scale score ≥4 at screening visit (for prior 24 hours) and baseline visit (weekly average over prior 7 days)
- Shorter stature defined for the study as ≤30th height-for-age percentile at screening, as defined in the protocol
- AD not adequately controlled with topical corticosteroid prescription therapies or when those therapies are not advisable, as defined in the protocol
- Key
Exclusion
- Females who have passed menarche at screening
- Concomitant skin diseases that may confound AD assessments in the opinion of the investigator
- Has a known medical issue which may contribute to shorter stature (eg, growth hormone deficiency, Celiac disease)
- Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline
- Has a known allergy or hypersensitivity to components of the study intervention
- Prior use of dupilumab or other biologic treatment for AD, as defined in the protocol
- Other advanced systemic treatment for AD within 4 weeks or non-steroidal topical treatments within 2 weeks before the baseline visit
- NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
Key Trial Info
Start Date :
November 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT07187089
Start Date
November 11 2025
End Date
January 5 2028
Last Update
November 28 2025
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