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Taking people in United StatesPhase 3

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

Key facts

Who runs it
Regeneron Pharmaceuticals
Where
Atlanta, Aurora, Boston, Chapel Hill, Charleston, Charlottesville, Fort Worth, Milwaukee, New York, Philadelphia, Phoenix, San Francisco, and Seattle, United StatesSee the 13 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
20 people, planned
Started
10 Nov 2025
Expected to end
9 Oct 2028
Type of study
Interventional, 2 groups
Treatments tested
  • dupilumab
Record updated
29 September 2026

Who can take part

Age
6 months to 6 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • Pediatric patients aged ≥6 months and weighing ≥5 kg and <15 kg at screening with active EoE
  • 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
  • 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

Who cannot take part

  • Prior participation in a dupilumab clinical trial or past or current treatment with dupilumab
  • 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
  • History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
  • Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy; NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
  • Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
  • Active Helicobacter pylori infection
  • 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
  • Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening

Where in United States

  • GI Care for Kids LLCAtlanta, United StatesContact: Clinical Trials AdministratorTaking people
  • Children's Hospital ColoradoAurora, United StatesContact: Clinical Trials AdministratorTaking people
  • Massachusetts General HospitalBoston, United StatesContact: Clinical Trials AdministratorTaking people
  • University of North Carolina, Bioinformatics BuildingChapel Hill, United StatesContact: Clinical Trials AdministratorTaking people
  • Medical University of South CarolinaCharleston, United StatesContact: Clinical Trials AdministratorTaking people
  • University of VirginiaCharlottesville, United StatesContact: Clinical Trials AdministratorTaking people
  • Cook Children's Medical CenterFort Worth, United StatesContact: Clinical Trials AdministratorTaking people
  • Medical College of Wisconsin/Children's Hospital of WisconsinMilwaukee, United StatesContact: Clinical Trials AdministratorTaking people
  • Weill Cornell MedicineNew York, United StatesContact: Clinical Trials AdministratorTaking people
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Clinical Trials AdministratorTaking people
  • Phoenix Childrens HospitalPhoenix, United StatesContact: Clinical Trials AdministratorTaking people
  • University of California, San Francisco (UCSF)San Francisco, United StatesContact: Clinical Trials AdministratorTaking people
  • Seattle Children's HospitalSeattle, United StatesContact: Clinical Trials AdministratorTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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)

The 2 groups in the trial

  • Dosing Regimen 1Treatment being tested

    Treatment: dupilumab

  • Dosing Regimen 2Treatment being tested

    Treatment: dupilumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
29 September 2026