Jeffrey A. Alexander, M.D.

The purpose of this study is to investigate the response rate of dietary therapy in patients with Eosinophilic Esophagitis (EoE) and determine rates of long-term compliance with the food elimination diets (SFED, FFED, step-up), and also to identify patient, clinical, and endoscopic factors that may be associated with increased rates of success in patients undergoing dietary therapy in EoE.

The primary objectives of the study by study part are:

Part A: To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures, and to inform/confirm the final sample size determination for Part B.

Part B: To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures.

Part C: To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures.

The secondary objectives of the study are: 

To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE.

To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses.

To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation

The purpose of this study is to see if the cytosponge ( a 10 minute, in office procedure that does not require sedation) can be used to replace the 6-10 endoscopies that are routinely performed during the standard of care dietary restriction and food reintroduction trials to manage eosinophilic esophagitis.

Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of dysphagia and food impaction in patients with EE.

Also evaluate tolerance and safety of oral montelukast in treatment of EE.

Whether the cytosponge will be a useful non-invasive tool in evaluating patients with eosinophilic esophagitis?

The purpose of this study is to determine if patients treated with long term maintenance medical therapies have a lowered risk of needing subsequent esophageal dilations, and to determine if there are characteristics (demographic, symptoms at initial dilation, biopsy characteristics) that increase risk of or are associated with needing subsequent dilation therapy.

The purpose of this study is to to evaluate the process of eating in patients with active EoE compared to inactive EoE and controls.

Researchers are trying to understand the course of Eosinophilic Esophagitis (EoE), its progression and effects of treatments.

The investigators would like to determine if there are patients with PPI responsive Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis.

If this group of patients exists, the investigators would like to determine if they have the typical endoscopic features of EoE rather than those of GERD.

The purpose of this study is to assess the clinical effectiveness of ESDT for patients with RBES defined as the number of endoscopic interventions  6 months following serial dilation.