The study is researching an experimental drug called dupilumab (called “study drug” in this form) for children with active eosinophilic esophagitis (EoE). EoE is an inflammatory disease of the esophagus which impacts feeding and nourishment.
Experimental means that dupilumab is not approved by the U.S. Food and Drug Administration (FDA).
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.
Dupilumab is administered via subcutaneous injection.
The general study procedures include vital signs, physical exams, lab tests, and an endoscopy, which includes biopsies.
Total participation is expected to last for about 9 months (36 weeks).
1. Male or female, aged 6 months or older at screening
2. Body weight greater than or equal to 5 kg and less than 15 kg at screening
3. History (by parent/caregiver report) of symptom(s) determined by the investigator to be the result of EoE (eg, poor weight gain, abdominal pain, chest pain, acid reflux, food regurgitation, dysphagia, vomiting, or refusal to eat) in the month prior to screening
Detailed eligibility will be reviewed when reaching out to the study team.