Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)

Key inclusion criteria

• Documented diagnosis of EoE by endoscopy prior to or at screening
• History of on average at least 2 episodes of dysphagia (with intake of solids off anti-inflammatory therapy) per week in the 4 weeks prior to screening and on average at least 2 episodes of documented dysphagia per week in the weeks between screening and baseline; dysphagia is defined as trouble swallowing solid food, or having solid food stick, by participant report
• Must remain on a stabilized diet for at least 6 weeks prior to screening and during the course of the study; stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups
• Documented history of or presence of any of the following: allergic disease (e.g, allergic asthma, allergic rhinitis, atopic dermatitis (AD), or food allergies), peripheral eosinophil counts ≥0.25 GI/L, or serum total Immunoglobulin E (IgE) ≥100 kU/L

Key Exclusion Criteria

• Prior participation in a dupilumab (anti-IL-4R) clinical trial
• Other causes of esophageal eosinophilia or the following diseases: hypereosinophilic syndromes, Churg-Strauss vasculitis, and eosinophilic gastroenteritis
• History of achalasia, active Helicobacter pylori infection, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery prior to screening
• Any esophageal stricture unable to be passed with a standard, diagnostic, adult (9 to10 mm) upper endoscope or any critical esophageal stricture that requires dilation at screening
• History of bleeding disorders or esophageal varices
• Use of chronic aspirin, nonsteroidal agents, or anti-coagulants within 2 weeks prior to screening. Participants should not stop these agents solely to become eligible for entry into this study
• Treatment with an investigational drug within 2 months or within 5 half-lives (if known), whichever is longer, prior to screening
• Use of systemic corticosteroids within 3 months or swallowed topical corticosteroids within 3 months prior to screening
• Use of inhaled (pulmonary or nasal) topical corticosteroids within 3 months prior to screening and during the study, except stable dose for at least 3 months prior to screening biopsy, which cannot be changed during the study
• Treatment with oral immunotherapy (OIT) within 6 months prior to screening
• Allergen immunotherapy unless on stable dose for at least 1 year prior to screening
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Note: The list of inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial.