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

NCT ID: NCT07187089

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-11
• Study Completion Date: 2028-01-05

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 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

Conditions

Severe Atopic Dermatitis (AD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dupilumab

Group Type: EXPERIMENTAL

dupilumab

Intervention Type: DRUG

Administered per the protocol

Interventions

dupilumab

Administered per the protocol

Intervention Type: DRUG

Other Intervention Names

DUPIXENT®; REGN668; SAR231893

Eligibility Criteria

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

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Other Identifiers

R668-AD-2372

Identifier Type: -

Identifier Source: org_study_id