A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis

Clinical Trial Details

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). 

Key Eligibility: 

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.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Olivia Ketcham
646.962.7162
olk4007@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2510029439

ClinicalTrials.gov:

NCT07112378

Sponsor:

R668-EE-2423

Status

Open to Enrollment

Age Group

Pediatric

Sponsor