Severe Atopic Dermatitis (AD)Phase 4BUILD-PEDSNCT07187089
Study of Growth and Bone Mineral Density in Children With Atopic Dermatitis (AD) Treated With Dupilumab
A Phase 4 study testing dupilumab in people with Severe Atopic Dermatitis (AD), run by Regeneron Pharmaceuticals.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Severe Atopic Dermatitis (AD)
- What is being tested?
- dupilumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2025to 5 Jan 2028
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: An Open-Label, Single-Arm Study to Assess Growth and Bone Mineral Density in Children ≥6 to <12 Years of Age With Severe Atopic Dermatitis Treated With Dupilumab
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)
- Being tested
- dupilumab
- Keywords
- Uncontrolled AD, Bone Mineral Accrual (BMA), Bone growth, Shorter stature, Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dupilumabDrug
Also called DUPIXENT®, REGN668, SAR231893
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| dupilumab | Experimental | Not described Receives: Drug: dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Baseline to Week 52
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Through Week 54
Occurrence of Serious Adverse Events (SAEs)
Measured: Through Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start11 Nov 2025 (estimated)
- Primary completion23 Dec 2027 (estimated)
- Study completion5 Jan 2028 (estimated)
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187089
- Sponsor's protocol ID
- R668-AD-2372
- Acronym
- BUILD-PEDS
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Study to Assess Growth and Bone Mineral Density in Children ≥6 to <12 Years of Age With Severe Atopic Dermatitis Treated With Dupilumab
- ClinicalTrials.gov ID
- NCT07187089
- Acronym / sponsor ID
- BUILD-PEDS / R668-AD-2372
- Conditions
- Severe Atopic Dermatitis (AD)
- Keywords
- Uncontrolled AD, Bone Mineral Accrual (BMA), Bone growth, Shorter stature, Eczema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 11 Nov 2025 (estimated)
- Primary completion
- 23 Dec 2027 (estimated)
- Study completion
- 5 Jan 2028 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dupilumab | Experimental | Drug: dupilumab |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dupilumabAlso: DUPIXENT®, REGN668, SAR231893Administered per the protocol | Drug | dupilumab |
Primary outcome
Improvement of ≥5 percentile in height-for-age percentile on the Centers for Disease Control and Prevention (CDC) growth chart
Time frame: Baseline to Week 52
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.
3 secondary outcomes
Change from baseline in Lumbar Spine (LS) Bone Mineral Density (BMD) adjusted Z-score measured by Dual-Energy X-Ray Absorptiometry (DEXA)
Time frame: Baseline to Week 52
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through Week 54
Occurrence of Serious Adverse Events (SAEs)
Time frame: Through Week 54
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dupilumab in people with Severe Atopic Dermatitis (AD), run by Regeneron Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of ≥5 percentile in height-for-age percentile on the Centers for Disease Control and Prevention (CDC) growth chart (time frame: Baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.