Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)
Public ClinicalTrials.gov record NCT04394351. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria. The Secondary objectives are: * To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS) * To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE * To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation * To study the effects of dupilumab on the type 2 inflammation gene expression signature * To evaluate the concentration-time profile of functional dupilumab in serum in this population * To assess efficacy of long-term (up to 160 weeks) dupilumab treatment * To assess the impact of dupilumab treatment on changes in weight and growth during the extended active period and open-label extension period of the study * To assess safety, tolerability, and immunogenicity of long-term (up to 160 weeks) dupilumab treatment * To evaluate the impact of dupilumab treatment on EoE signs and symptoms
Study identification
- NCT ID
- NCT04394351
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 102 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Year to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 1, 2020 (Actual)
- Primary completion
- Jun 2, 2022 (Actual)
- Completion
- May 14, 2024 (Actual)
- Last update posted
- Oct 27, 2025
2020 – 2024
United States locations
- U.S. sites
- 26
- U.S. states
- 17
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Study Site | Phoenix | Arizona | 85016 | — |
| Regeneron Study Site | Little Rock | Arkansas | 72202 | — |
| Regeneron Study Site | Los Angeles | California | 90027 | — |
| Regeneron Study Site | San Francisco | California | 94143 | — |
| Regeneron Study Site | Aurora | Colorado | 80045 | — |
| Regeneron Study Site | St. Petersburg | Florida | 33701 | — |
| Regeneron Study Site | Atlanta | Georgia | 30322 | — |
| Regeneron Study Site | Atlanta | Georgia | 30342 | — |
| Regeneron Study Site | Chicago | Illinois | 60611 | — |
| Regeneron Study Site | Indianapolis | Indiana | 46202 | — |
| Regeneron Study Site | Iowa City | Iowa | 52242 | — |
| Regeneron Study Site | Boston | Massachusetts | 02111 | — |
| Regeneron Study Site | Boston | Massachusetts | 02114 | — |
| Regeneron Study Site | Boston | Massachusetts | 02115 | — |
| Regeneron Study Site | Lincoln | Nebraska | 68510 | — |
| Regeneron Study Site | New York | New York | 10029 | — |
| Regeneron Study Site | New York | New York | 10032 | — |
| Regeneron Study Site | New York | New York | 10065 | — |
| Regeneron Study Site | Chapel Hill | North Carolina | 27599 | — |
| Regeneron Study Site | Cincinnati | Ohio | 45229 | — |
| Regeneron Study Site | Cleveland | Ohio | 44106 | — |
| Regeneron Study Site | Philadelphia | Pennsylvania | 19104 | — |
| Regeneron Study Site | Dallas | Texas | 75207 | — |
| Regeneron Study Site | Fort Worth | Texas | 76104 | — |
| Regeneron Study Site | Houston | Texas | 77030 | — |
| Regeneron Study Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04394351, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 27, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04394351 live on ClinicalTrials.gov.