D5244C00001 Enrolling

Clinical Trial for Eosinophilic Esophagitis (96 Weeks)


Treatment: Injection Age: 12 to 80 years


Recruiting adolescents and adults for a clinical trial with an investigational injected treatment for eosinophilic esophagitis (EoE).

Eligible participants will:

  • be 12 to 80 years of age inclusive
  • have a weight of ≥ 40 kg at Visit 1
  • have a previously established diagnosis of EoE by EGD (esophagogastroduodenoscopy) and esophageal biopsy
  • have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia (any severity of food going down slowly or being stuck in the throat) per week in the 4 weeks prior to Visit 1
  • have been on stabilized diet for at least 8 weeks prior to Visit 1 and be willing to remain on stabilized diet 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)
  • be able to be on any background medication for EoE, for example PPI (proton pump inhibitor) and/or STC (swallowed topical corticosteroids), during the course of the study, as long as background medications have been stable for at least 8 weeks prior to the screening/run-in period (Visit 1)

Participants will receive investigational treatment (active study drug) or placebo, via subcutaneous injection. At Week 52, individuals who enter the active treatment extension period and who previously received placebo will then receive active study drug. Study treatment and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.

Study participation will last about 96 weeks and involve about 23 visits to the study centre.


Participating Locations

COUNTRY
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Canada

Participating Experts

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The following information is from ClinicalTrials.gov

Last Update Posted: July 15, 2024

Official Title

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING).

ClinicalTrials.gov ID

NCT05583227

Sponsor

AstraZeneca

Study Description

  • Brief Summary:

    A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).

  • Condition or Disease:

    Eosinophilic Esophagitis

  • Intervention/Treatment:

    Biological: Tezepelumab Biological: Tezepelumab Other: Placebo
  • Phase:

    PHASE3

  • Ages Eligible for Study:

    12 Years and 80 Years (CHILD,ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL

Eligible participants will:

  • be 12 to 80 years of age inclusive
  • have a weight of ≥ 40 kg at Visit 1
  • have a previously established diagnosis of EoE by EGD (esophagogastroduodenoscopy) and esophageal biopsy
  • have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia (any severity of food going down slowly or being stuck in the throat) per week in the 4 weeks prior to Visit 1
  • have been on stabilized diet for at least 8 weeks prior to Visit 1 and be willing to remain on stabilized diet 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)
  • be able to be on any background medication for EoE, for example PPI (proton pump inhibitor) and/or STC (swallowed topical corticosteroids), during the course of the study, as long as background medications have been stable for at least 8 weeks prior to the screening/run-in period (Visit 1)

Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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