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  • A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) (EoE) Rochester, Minn.

    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

  • A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis Rochester, Minn.

    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.

  • Does Continued Medical Management Prevent the Need for Recurrent Dilation in Eosinophilic Esophagitis? Rochester, Minn.

    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.

  • Eating Behavior in Patients with Eosinophilic Esophagitis Rochester, Minn.

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

  • Natural History of Eosinophilic Esophagitis: A Longitudinal Follow-up Over 10 Years (EoE) Rochester, Minn.

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

  • PPI Responsive Esophageal Eosinophilia: GERD or Eosinophilic Esophagitis? Rochester, Minn.

    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.

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