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

RecruitingPhase 3

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

Who can join

6 Months – 6 Years · All sexes

Full eligibility criteria
Key Inclusion Criteria:

1. Pediatric patients aged ≥6 months and weighing ≥5 kg and \<15 kg at screening with active EoE
2. History of symptom(s) determined by the investigator to be the result of EoE in the month prior to screening, as defined in the protocol
3. Baseline endoscopic biopsies, performed during the screening period, with a demonstration on central reading of intraepithelial eosinophilic infiltration in at least 2 of the 3 biopsied esophageal regions, as defined in the protocol

Key Exclusion Criteria:

1. Prior participation in a dupilumab clinical trial or past or current treatment with dupilumab
2. Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Patients on a food-elimination diet must remain on the same diet throughout the study
3. Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
4. Active Helicobacter pylori infection
5. History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
6. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
7. History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopic procedure
8. Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy

NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply

About the study

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)

What is being tested

Sponsor: Regeneron Pharmaceuticals · Participants: 20 · Started: Nov 10, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07112378

Locations in the U.S.

ArizonaPhoenix Childrens Hospital, Phoenix
CaliforniaUniversity of California San Francisco (UCSF), San Francisco
ColoradoChildren's Hospital Colorado, Aurora
GeorgiaGI Care for Kids LLC, Atlanta
MassachusettsMassachusetts General Hospital, Boston
New YorkWeill Cornell Medicine, New York
North CarolinaUniversity of North Carolina, Bioinformatics Building, Chapel Hill
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia
South CarolinaMedical University of South Carolina, Charleston
TexasCook Children's Medical Center, Fort Worth
VirginiaUniversity of Virginia, Charlottesville
WashingtonSeattle Children's Hospital, Seattle
WisconsinMedical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.