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Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

NCT05583227 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2026-04-21

No results posted yet for this 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).

Conditions

  • Eosinophilic Esophagitis

Interventions

BIOLOGICAL

Tezepelumab

Tezepelumab subcutaneous injection

BIOLOGICAL

Tezepelumab

Tezepelumab subcutaneous injection

OTHER

Placebo

Placebo subcutaneous injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-10
Primary Completion
2026-07-14
Completion
2027-03-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Norway
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05583227 on ClinicalTrials.gov