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

NCT07187089 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: R668-AD-2372
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Uncontrolled AD; Bone Mineral Accrual (BMA); Bone growth; Shorter stature; Eczema

Outcome Measures

Primary Outcomes (1)

• Improvement of ≥5 percentile in height-for-age percentile on the Centers for Disease Control and Prevention (CDC) growth chart

  The Centers for Disease Control and Prevention (CDC) growth charts use percentile scales as a measurement system. The percentile scale is a ranking system that compares a child's growth measurements (e.g., height, weight, Body Mass Index \[BMI\]) to a reference population of the same age and sex.

  Baseline to Week 52

Secondary Outcomes (3)

• Change from baseline in Lumbar Spine (LS) Bone Mineral Density (BMD) adjusted Z-score measured by Dual-Energy X-Ray Absorptiometry (DEXA)

  Baseline to Week 52

• Occurrence of Treatment-Emergent Adverse Events (TEAEs)

  Through Week 54

• Occurrence of Serious Adverse Events (SAEs)

  Through Week 54

Study Arms (1)

dupilumab

EXPERIMENTAL

Drug: dupilumab

Interventions

dupilumab DRUG

Administered per the protocol

Also known as: DUPIXENT®, REGN668, SAR231893

dupilumab

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): December 23, 2027
• Study Completion (Estimated): January 5, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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
• Access Criteria: 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