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Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
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).
Study details:
The study consists of a screening period of 2 to 8 weeks and a 52-week randomized double-blind placebo-controlled treatment period. After completion of the treatment period, participants will be eligible to participate in an optional active treatment extension period (lasting for 24 weeks), followed by a 12-week off-treatment safety follow-up period. Participants who will not participate in the extension period will participate in a 12-week off-treatment safety follow-up period following completion of the 52-week treatment period.
This study will randomize approximately 360 participants. The participants will be randomized at 1:1:1 ratio to the 3 treatment arms.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 12 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-11-10
Primary completion: 2026-05-01
Study completion finish: 2027-01-08
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05583227
Intervention or treatment
BIOLOGICAL: Tezepelumab
BIOLOGICAL: Tezepelumab
OTHER: Placebo
Conditions
- • Eosinophilic Esophagitis
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
Elizabeth Vale, Not Specified, Australia
Research Site
Kogarah, Not Specified, Australia
Research Site
Mitcham, Not Specified, Australia
Research Site
South Brisbane, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Tezepelumab Low Dose
| BIOLOGICAL: Tezepelumab
|
EXPERIMENTAL: Tezepelumab High Dose
| BIOLOGICAL: Tezepelumab
|
PLACEBO_COMPARATOR: Placebo
| OTHER: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels | Peak esophageal eosinophil count per HPF determined by histological analysis of 2-4 biopsies from each of the proximal, mid, and distal esophagus. | Week 24 |
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score | 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. | Week 24 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Change from baseline in EoE EREFS (Endoscopic reference score ) | The EoE EREFS is a scoring system for assessing the presence and severity of the major endoscopic signs of EoE, including esophageal edema, rings, exudates, furrows, and stricture. EoE endoscopic appearances will be analyzed by the EoE-EREFS, a scoring system for inflammatory and fibrostenotic features of the disease. Proximal and distal esophageal areas will be scored, with the score for each region ranging from 0 to 9, and the overall score ranging from 0 to 18. Higher scores indicate more extensive disease. | Week 24, Week 52 |
Change from baseline in EoE-HSS (Histologic scoring system) grade score | EoE HSS is a histology scoring system for esophageal biopsies that evaluates 8 features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. Severity (grade) and extent (stage) of abnormalities are scored using a 4-point scale (0 normal; 3 maximum change). | Week 24 |
Change from baseline in EoE-HSS (Histologic scoring system) stage score | EoE HSS is a histology scoring system for esophageal biopsies that evaluates 8 features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. Severity (grade) and extent (stage) of abnormalities are scored using a 4-point scale (0 normal; 3 maximum change). | Week 24 |
Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels | The peak esophageal eosinophil count is based on 2-4 esophageal biopsies from 2-3 locations. | Week 52 |
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score | 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. | Week 52 |
Response of achieving clinico-histological remission | Achieving pre-determined histologic and symptomatic remission thresholds. | Week 24, Week 52 |
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