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)
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
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
Parallel
dupilumab
DrugAdministered as defined in the protocol
Incidence of treatment-emergent Serious Adverse Events (SAEs)
Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to permanent discontinuation of study treatment
Incidence of treatment-emergent Adverse Event of Special Interest (AESIs)
Incidence of TEAEs
Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high power field (eos/hpf) (400×)
Click on the lead sponsor to view all of their trials.
Regeneron Pharmaceuticals
Lead sponsor
Sanofi
Collaborator
