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Clinical Trials in the USA / NCT07112378
Recruiting Phase 3

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

NCT07112378 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 3
Started
2025-11-10
Last updated
2026-08-20

Condition(s) studied

Eosinophilic Esophagitis (EoE)

Investigational drug(s) / intervention(s)

dupilumab →

dupilumab: Administered as defined in the protocol

Study 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)

Eligibility

Sex
ALL
Min age
6 Months
Max age
6 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Phoenix Childrens Hospital Phoenix Arizona Recruiting
University of California San Francisco (UCSF) San Francisco California Recruiting
Children's Hospital Colorado Aurora Colorado Recruiting
GI Care for Kids LLC Atlanta Georgia Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Weill Cornell Medicine New York New York Recruiting
University of North Carolina, Bioinformatics Building Chapel Hill North Carolina Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Cook Children's Medical Center Fort Worth Texas Recruiting
University of Virginia Charlottesville Virginia Recruiting
Seattle Children's Hospital Seattle Washington Recruiting
Medical College of Wisconsin, Children's Hospital of Wisconsin Milwaukee Wisconsin Recruiting

On this site

📄 Dupixent (dupilumab) drug profile →

More Regeneron Pharmaceuticals trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07112378 on ClinicalTrials.gov ↗ ← All trials in the USA