NCT07112378

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

A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Eosinophilic Esophagitis (EoE)

Interventions

Type	Name	Description
DRUG	dupilumab	Administered as defined in the protocol

Timeline

• Start date: 2025-11-10
• Primary completion: 2028-06-19
• Completion: 2028-10-09
• First posted: 2025-08-08
• Last updated: 2026-04-08

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study