Study of Growth and Bone Mineral Density in Children With Atopic Dermatitis (AD) Treated With Dupilumab (BUILD-PEDS)

Regeneron Pharmaceuticals

Status and phase: Withdrawn; Phase 4

Conditions: Severe Atopic Dermatitis (AD)

Treatments: Drug: dupilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07187089

R668-AD-2372

Details and patient eligibility

About

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

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Children with body weight ≥15 kg and <60 kg at screening visit 1
2. Diagnosis of AD according to American Academy of Dermatology consensus criteria at time of screening visit
3. Investigator Global Assessment (IGA) score = 4 at screening and baseline visits
4. ≥15% Body Surface Area (BSA) of AD involvement at the screening and baseline visits
5. Worst Itch Scale score ≥4 at screening visit (for prior 24 hours) and baseline visit (weekly average over prior 7 days)
6. Shorter stature defined for the study as ≤30th height-for-age percentile at screening, as defined in the protocol
7. AD not adequately controlled with topical corticosteroid prescription therapies or when those therapies are not advisable, as defined in the protocol

Key Exclusion Criteria:

1. Females who have passed menarche at screening
2. Concomitant skin diseases that may confound AD assessments in the opinion of the investigator
3. Has a known medical issue which may contribute to shorter stature (eg, growth hormone deficiency, Celiac disease)
4. Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline
5. Has a known allergy or hypersensitivity to components of the study intervention
6. Prior use of dupilumab or other biologic treatment for AD, as defined in the protocol
7. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

dupilumab

Experimental group

Treatment:

Drug: dupilumab