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

Study of Investigational Medication for Eosinophilic Esophagitis in Young Children

Recruiting
6 months - 6 years
All
Phase 3
20 participants needed
8 Locations

Study Overview

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 Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Eosinophilic Esophagitis (EoE)
  • Age: 6 months - 6 years
  • Gender: All

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

This study investigates an investigational medication for children with eosinophilic esophagitis (EoE), a condition affecting the esophagus that can impact feeding and nourishment. The purpose of this study is to explore the safety, tolerability, and effectiveness of the investigational medication in these young patients.

The study is focused on understanding potential side effects, how the medication is processed in the body, and if the body produces antibodies that might affect the medication's effectiveness or cause side effects. This research aims to gather important information about how the medication interacts with the body over time.

  • Who can participate: Children aged 6 months to under 15 kg with active eosinophilic esophagitis can participate. Key factors include having specific symptoms and biopsy results related to EoE.
  • Study details: Participants will receive the investigational medication and undergo various assessments to monitor safety and effectiveness. The study will also check for any side effects and how the medication is processed in the body.
  • Study timelines: The study will last 24 weeks.
Updated on 07 Apr 2026. Study ID: NCT07112378

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