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NCT07112378From ClinicalTrials.govRecruiting

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

  • Eosinophilic Esophagitis (EoE)

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Regeneron Pharmaceuticals
Enrolment target
20
Started
10 November 2025
Main results due
19 June 2028
Study sites
13
Registry updated
29 September 2026

Can you take part?

  • Ages 6 months to 6 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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

What this study is about

In the sponsor’s own words, from the registry.

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)

Study sites(13)

  • Phoenix Childrens Hospital

    Phoenix, Arizona, United States

    Recruiting

  • University of California San Francisco (UCSF)

    San Francisco, California, United States

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, United States

    Recruiting

  • GI Care for Kids LLC

    Atlanta, Georgia, United States

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

    Recruiting

  • Weill Cornell Medicine

    New York, New York, United States

    Recruiting

  • University of North Carolina, Bioinformatics Building

    Chapel Hill, North Carolina, United States

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, United States

    Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas, United States

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, United States

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, United States

    Recruiting

  • Medical College of Wisconsin, Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, United States

    Recruiting

Showing 13 of 13 sites. 13 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07112378. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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