A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis

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