A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
Investigating an Investigational Medication in Children with Eosinophilic Esophagitis
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)
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Age: 6 months - 6 years
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Gender: All
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
- 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 Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
- Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
- 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
- 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 in children with eosinophilic esophagitis. The purpose of this study is to evaluate the safety, tolerability, and effectiveness of the investigational medication over a 24-week period in children with active eosinophilic esophagitis.
Participants will receive the investigational medication, and researchers will monitor for side effects, measure drug levels in the blood, and check for any antibodies that might affect the drug's effectiveness or cause side effects. Eosinophilic esophagitis is diagnosed through biopsies showing eosinophilic infiltration in the esophagus, which is a buildup of a type of white blood cell that indicates inflammation.
- Who can participate: Children aged 6 months to less than 15 kg with active eosinophilic esophagitis and specific biopsy results can participate. Exclusion criteria include prior treatment with dupilumab and recent changes in diet.
- Study details: Participants will receive the investigational medication with monitoring for side effects and drug levels. Researchers will also check for antibodies against the investigational medication.
- Study timelines: The study will last 24 weeks.