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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