A Phase 3 Randomized 3-Part Study To Investigate The Efficacy And Safety Of Dupilumab In Adult And Adolescent Patients With Eosinophilic Esophagitis

  • STATUS
    Enrolling By Invitation
  • participants needed
    20
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Updated on 19 February 2024

Summary

Brief Summary: 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.

Description


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Details
Condition Eosinophilic Esophagitis
Age 18years - 99years
Clinical Study Identifier03633617
Last Modified on19 February 2024

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If you need help finding a study or have any questions, please contact us at psom-ocr@pobox.upenn.edu

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