A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis
Regeneron Pharmaceuticals
Summary
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
- Age range
- 0–6 years
- Sex
- All
- Healthy volunteers
- No
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 trea…
Interventions
- Drugdupilumab
Administered as defined in the protocol
Locations (8)
- Phoenix Childrens HospitalPhoenix, Arizona
- Children's Hospital ColoradoAurora, Colorado
- GI Care for Kids LLCAtlanta, Georgia
- Weill Cornell MedicineNew York, New York
- University of North Carolina, Bioinformatics BuildingChapel Hill, North Carolina
- Medical University of South CarolinaCharleston, South Carolina