Efficacy and Safety of Tezepelumab in Patients with Eosinophilic Esophagitis - CROSSING

Study identifier:D5244C00001

ClinicalTrials.gov identifier:NCT05583227

EudraCT identifier:2022-001294-31

CTIS identifier:2023-504277-20-00

Recruiting

Official Title

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

Medical condition

Eosinophilic Esophagitis

Phase

Phase 3

Healthy volunteers

Study drug

Sex

All

Estimated Enrollment

360

Study type

Interventional

Age

12 Years - 80 Years

Date

Study Start Date: 10 Nov 2022

Estimated Primary Completion Date: 01 May 2026

Estimated Study Completion Date: 08 Jan 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2024 by AstraZeneca

Collaborators

Amgen

Inclusion and exclusion criteria

Inclusion Criteria

1. Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent.
2. Weight ≥ 40 kg at Visit 1
3. Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE.
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. 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. 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. 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. 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. Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet.

Exclusion Criteria

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.Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.
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. Hypereosinophilic syndrome
5. EGPA vasculitis
6. Esophageal dilation performed within 8 weeks prior to screening.

Sort by status

No locations available

Arms	Assigned Interventions
Experimental: Tezepelumab Low Dose Tezepelumab subcutaneous injections, in accessorised pre-filled syringes	Biological/Vaccine: Tezepelumab Tezepelumab subcutaneous injection Other Name: Tezepelumab
Experimental: Tezepelumab High Dose Tezepelumab subcutaneous injections, in accessorised pre-filled syringes	Biological/Vaccine: Tezepelumab Tezepelumab subcutaneous injection Other Name: Tezepelumab
Placebo Comparator: Placebo Placebo subcutaneous injections, in accessorised pre-filled syringes	Other: Placebo Placebo subcutaneous injection Other Name: Placebo

Documents available

This webpage was designed to learn about the work AstraZeneca is doing to develop Eosinophilic Esophagitis (EoE) treatments and find out how you could get involved in a clinical trial.
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

EoE Trial & You Clinical Trial Navigator

1-844-432-3890