A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
Research Study of Investigational Medication for 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 the effects of an investigational medication in children who have eosinophilic esophagitis. The purpose of this study is to understand how this condition impacts young children.
The study focuses on evaluating the safety, tolerability, and effectiveness of the investigational medication over a period of time. Researchers are also interested in understanding potential side effects, how the body processes the medication, and whether the body develops antibodies against it.
- Who can participate: Children aged 6 months and weighing at least 5 kg with active eosinophilic esophagitis can participate. Key factors include a history of symptoms due to eosinophilic esophagitis and specific results from endoscopic biopsies.
- Study details: Participants will receive the investigational medication for 24 weeks. The study will monitor the effects and safety of the medication, including any side effects and how the body reacts to it. A placebo, an inactive substance that looks like the investigational medicine/vaccine but does not contain any medicine, may also be used for comparison.
- Study timelines: The study will last 24 weeks.