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A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
Sponsor: Regeneron Pharmaceuticals
Summary
This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment. The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Official title: A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis
Key Details
Gender
All
Age Range
6 Months - 6 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-11-10
Completion Date
2028-10-09
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
dupilumab
Administered as defined in the protocol
Locations (8)
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Children's Hospital Colorado
Aurora, Colorado, United States
GI Care for Kids LLC
Atlanta, Georgia, United States
Weill Cornell Medicine
New York, New York, United States
University of North Carolina, Bioinformatics Building
Chapel Hill, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
University of Virginia
Charlottesville, Virginia, United States