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A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis
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
This is a 3-part study: * Part A: Double-blind 16-week treatment period * Part B: 36-week extended active treatment period * Part C: Up to108 weeks open-label extension period
Age
1 - 11 years
Sex
ALL
Healthy Volunteers
No
Regeneron Study Site
Phoenix, Arizona, United States
Regeneron Study Site
Little Rock, Arkansas, United States
Regeneron Study Site
Los Angeles, California, United States
Regeneron Study Site
San Francisco, California, United States
Regeneron Study Site
Aurora, Colorado, United States
Regeneron Study Site
St. Petersburg, Florida, United States
Regeneron Study Site
Atlanta, Georgia, United States
Regeneron Study Site
Atlanta, Georgia, United States
Regeneron Study Site
Chicago, Illinois, United States
Regeneron Study Site
Indianapolis, Indiana, United States
Start Date
September 1, 2020
Primary Completion Date
June 2, 2022
Completion Date
May 14, 2024
Last Updated
October 27, 2025
102
ACTUAL participants
Dupilumab
DRUG
Matching Placebo
DRUG
Lead Sponsor
Regeneron Pharmaceuticals
Collaborators
NCT06693531
NCT06389994
NCT03581838
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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