A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)

Ki vehet részt

• A documented diagnosis of EoE by endoscopic biopsy
• Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration
• History (by participant report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening
• Body weight ≥40 kg

Ki nem vehet részt

• History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery
• Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline
• Initiation or change of a food elimination diet regimen or reintroduction of a previously eliminated food group in the 6 weeks prior to screening
• Participation in prior dupilumab clinical study or participants currently treated or have been treated with commercially available dupilumab or contraindicated to dupilumab per local labelling; The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
• Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome)
• Active Helicobacter pylori infection
• History of bleeding disorders or esophageal varices
• Participants are excluded from the study if any of the following criteria apply:
• Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening