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RECRUITING
NCT07112378
PHASE3

A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

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