Sponsor Decision

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 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

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

When Regeneron has:

• received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
• made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
• the legal authority to share the data, and
• ensured the ability to protect participant privacy

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf