ACTIVE_NOT_RECRUITING

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

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Conditions

Eosinophilic EsophagitisChronic EsophagitisEosinophilic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-11-10
Study Completion:2027-03-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05583227

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent.
  2. 2. Weight ≥ 40 kg at Visit 1
  3. 3. Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE.
  4. 4. Participants who 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.
  5. 5. Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 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).
  6. 6. May be on any background PPI and/or STC, 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) and there is agreement not to change background medication or dosage unless medically indicated, during the screening/run-in and treatment period.
  7. 7. Participants currently on leukotriene inhibitors and/or steroid treatments for asthma or allergies that are inhaled or administered intranasally, must report a stable dose for at least 4 weeks prior to the screening/run-in period (Visit 1).
  8. 8. If a medication for EoE (for example PPI and/or STC) is discontinued prior to the screening/run-in, there should be a washout period of at least 8 weeks prior to Visit 1. Discontinuation of any marketed biologic (monoclonal or polyclonal antibody) should have a washout period of 4 months or 5 half-lives prior to Visit 1, whichever is longer.
  9. 9. Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet.
  1. 1. Other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, celiac disease, eosinophilic enteritis, colitis, diverticulitis, irritable bowel syndrome, or other clinically significant gastrointestinal conditions as per Investigator discretion.
  2. 2. Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.
  3. 3. Use of a feeding tube, or having a pattern of not eating solid food \>3 days of week. Solid food is defined as food that requires chewing before swallowing.
  4. 4. Hypereosinophilic syndrome
  5. 5. EGPA vasculitis
  6. 6. Esophageal dilation performed within 8 weeks prior to screening.

Contacts and Locations

Study Locations (Sites)

Research Site
Phoenix, Arizona, 85016
United States
Research Site
Little Rock, Arkansas, 72202
United States
Research Site
Los Angeles, California, 90033
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
Inverness, Florida, 34452
United States
Research Site
Jacksonville, Florida, 32256
United States
Research Site
Saint Augustine, Florida, 32086
United States
Research Site
Normal, Illinois, 61761
United States
Research Site
Iowa City, Iowa, 52242
United States
Research Site
Topeka, Kansas, 66606
United States
Research Site
White Marsh, Maryland, 21162
United States
Research Site
Boston, Massachusetts, 02111
United States
Research Site
Chesterfield, Michigan, 48047
United States
Research Site
Lincoln, Nebraska, 68503
United States
Research Site
Ocean City, New Jersey, 07712
United States
Research Site
Brooklyn, New York, 11235
United States
Research Site
Chapel Hill, North Carolina, 27599
United States
Research Site
Cincinnati, Ohio, 45229
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Smithfield, Pennsylvania, 15478
United States
Research Site
Nashville, Tennessee, 37232
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Salt Lake City, Utah, 84107
United States
Research Site
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-10
Study Completion Date2027-03-25

Study Record Updates

Study Start Date2022-11-10
Study Completion Date2027-03-25

Terms related to this study

Keywords Provided by Researchers

  • Chronic Esophagitis
  • Eosinophilic Esophagitis
  • Eosinophilic

Additional Relevant MeSH Terms

  • Eosinophilic Esophagitis