Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels — Week 24
Peak esophageal eosinophil count per HPF determined by histological analysis of 2-4 biopsies from each of the proximal, mid, and distal esophagus. - Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score — Week 24
The Dysphagia Symptom Questionnaire (DSQ) captures the presence and severity of dysphagia symptoms in the past day in a 4-item questionnaire. The DSQ score is calculated over 14-day periods and ranges from 0 to 84, with a lower score indicating less severe dysphagia.
Trial sites (124)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Spain
Other trials for the same condition
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 Spain