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Clinical Trials in the UK / NCT05583227
Active, not recruiting Phase 3

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

NCT05583227 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2022-11-10
Last updated
2026-07-30

Condition(s) studied

Eosinophilic Esophagitis

Investigational drug(s) / intervention(s)

TezepelumabTezepelumabPlacebo

Tezepelumab: Tezepelumab subcutaneous injection

Tezepelumab: Tezepelumab subcutaneous injection

Placebo: Placebo subcutaneous injection

Study 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).

Eligibility

Sex
ALL
Min age
12 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (124)

FacilityCityRegionStatus
Research Site Phoenix Arizona
Research Site Little Rock Arkansas
Research Site Los Angeles California
Research Site Aurora Colorado
Research Site Inverness Florida
Research Site Jacksonville Florida
Research Site Saint Augustine Florida
Research Site Normal Illinois
Research Site Iowa City Iowa
Research Site Topeka Kansas
Research Site White Marsh Maryland
Research Site Boston Massachusetts
Research Site Chesterfield Michigan
Research Site Lincoln Nebraska
Research Site Ocean City New Jersey
Research Site Brooklyn New York
Research Site Chapel Hill North Carolina
Research Site Cincinnati Ohio
Research Site Philadelphia Pennsylvania
Research Site Uniontown Pennsylvania
Research Site Nashville Tennessee
Research Site Houston Texas
Research Site Salt Lake City Utah
Research Site Salt Lake City Utah
Research Site Elizabeth Vale Australia
Research Site Kogarah Australia
Research Site South Brisbane Australia
Research Site Woolloongabba Australia
Research Site Vienna Austria
Research Site Wels Austria
Research Site Bruges Belgium
Research Site Edegem Belgium
Research Site Ghent Belgium
Research Site Leuven Belgium
Research Site Botucatu Brazil
Research Site Brasília Brazil
Research Site Caxias do Sul Brazil
Research Site Curitiba Brazil
Research Site Curitiba Brazil
Research Site Porto Alegre Brazil

+ 84 more sites — see the full list on the official registry below.

On this site

📄 Tezspire (tezepelumab) drug profile →

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05583227 on ClinicalTrials.gov ↗ ← All trials in the UK