Back to resultsEfficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING)
Primary Purpose
Eosinophilic Esophagitis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tezepelumab
Tezepelumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Chronic Esophagitis, Eosinophilic Esophagitis, Eosinophilic
Eligibility Criteria
Inclusion Criteria:
- Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent.
- Weight ≥ 40 kg at Visit 1
- Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE.
- 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.
- 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).
- 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.
- Participants currently 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).
- If a medication for EoE (including 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.
- Participants must have previously documented standard of care treatment, which could include PPI and/or STC and/or diet.
Exclusion Criteria:
- 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.
- Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.
- Use of a feeding tube, or having a pattern of not eating solid food daily.
- Hypereosinophilic syndrome, defined by multiple organ involvement and persistent blood eosinophil count > 1500 eosinophils/μL
- EGPA vasculitis
- Esophageal dilation performed within 8 weeks prior to screening.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Tezepelumab Low Dose
Tezepelumab High Dose
Placebo
Arm Description
Tezepelumab subcutaneous injections, in accessorised pre-filled syringes
Tezepelumab subcutaneous injections, in accessorised pre-filled syringes
Placebo subcutaneous injections, in accessorised pre-filled syringes
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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).
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).
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.
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.
Response of achieving clinico-histological remission
Achieving pre-determined histologic and symptomatic remission thresholds.
Full Information
NCT ID
NCT05583227
First Posted
October 13, 2022
Last Updated
September 27, 2023
Sponsor
AstraZeneca
Collaborators
Amgen
1. Study Identification
Unique Protocol Identification Number
NCT05583227
Brief Title
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Acronym
CROSSING
Official Title
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING).
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
January 8, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Chronic Esophagitis, Eosinophilic Esophagitis, Eosinophilic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized in a 1:1:1 ratio to receive either low dose of tezepelumab, high dose of tezepelumab, or placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tezepelumab Low Dose
Arm Type
Experimental
Arm Description
Tezepelumab subcutaneous injections, in accessorised pre-filled syringes
Arm Title
Tezepelumab High Dose
Arm Type
Experimental
Arm Description
Tezepelumab subcutaneous injections, in accessorised pre-filled syringes
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo subcutaneous injections, in accessorised pre-filled syringes
Intervention Type
Biological
Intervention Name(s)
Tezepelumab
Intervention Description
Tezepelumab subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Tezepelumab
Intervention Description
Tezepelumab subcutaneous injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneous injection
Primary Outcome Measure Information:
Title
Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels
Description
Peak esophageal eosinophil count per HPF determined by histological analysis of 2-4 biopsies from each of the proximal, mid, and distal esophagus.
Time Frame
Week 24
Title
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change from baseline in EoE EREFS (Endoscopic reference score )
Description
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.
Time Frame
Week 24, Week 52
Title
Change from baseline in EoE-HSS (Histologic scoring system) grade score
Description
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).
Time Frame
Week 24
Title
Change from baseline in EoE-HSS (Histologic scoring system) stage score
Description
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).
Time Frame
Week 24
Title
Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels
Description
The peak esophageal eosinophil count is based on 2-4 esophageal biopsies from 2-3 locations.
Time Frame
Week 52
Title
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score
Description
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.
Time Frame
Week 52
Title
Response of achieving clinico-histological remission
Description
Achieving pre-determined histologic and symptomatic remission thresholds.
Time Frame
Week 24, Week 52
Other Pre-specified Outcome Measures:
Title
Change from baseline in peak esophageal eosinophil count (EOS/HPF)
Description
The EOS/HPF is a method of evaluating esophageal inflammation by histological response of eosinophils per high power field (HPF).
Time Frame
Week 24, Week 52
Title
Changes from baseline in PEESS Module at Week 24 (adolescents only).
Description
The PEESS is an 20-item assessment of EoE symptom severity and frequency validated for use in patients aged 8 to 18 years. The overall score ranges from 0 to 80, with higher scores representing more severe and frequent EoE symptoms.
Time Frame
Week 24, Week 52
Title
Change from baseline in EoE-HSS (Histologic scoring system) stage score
Description
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. Extent (stage) of abnormalities is scored using a 4-point scale (0 normal; 3 maximum change).
Time Frame
Week 52
Title
Change from baseline in EoE-HSS (Histologic scoring system) grade score
Description
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) of abnormalities is scored using a 4-point scale (0 normal; 3 maximum change).
Time Frame
Week 52
Title
Serum tezepelumab concentration
Description
PK samples will be collected pre-dose. Tezepelumab concentration in serum is determined using bioanalytical method.
Time Frame
Weeks 0, 4, 12, 24, and 52
Title
Anti-drug antibody
Description
Anti-drug antibody is determined using bioanalytical method.
Time Frame
Weeks 0, 12, 24, and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent.
Weight ≥ 40 kg at Visit 1
Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE.
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.
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).
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.
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).
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.
Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet.
Exclusion Criteria:
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.
Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.
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.
Hypereosinophilic syndrome
EGPA vasculitis
Esophageal dilation performed within 8 weeks prior to screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carebox Healthcare Solutions Inc
Phone
1-844-432-3890
Email
az-crossing@careboxhealth.com
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68503
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Elizabeth Vale
ZIP/Postal Code
5112
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mitcham
ZIP/Postal Code
3132
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
South Brisbane
ZIP/Postal Code
QL 4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wels-Grieskirchen
ZIP/Postal Code
4600
Country
Austria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Botucatu
ZIP/Postal Code
18618-687
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brasilia
ZIP/Postal Code
71681-603
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Caxias do Sul
ZIP/Postal Code
95070-560
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
80250-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
80440-220
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
05.403-010
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1G5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2H 1H5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 6C6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 2G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3T2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
430033
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310052
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
2100008
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Praha
ZIP/Postal Code
190 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Research Site
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Research Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Research Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hämeenlinna
ZIP/Postal Code
13530
Country
Finland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Landsberg
ZIP/Postal Code
86899
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
München
ZIP/Postal Code
80337
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Research Site
City
München
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11521
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527, GR
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Petah Tikva
ZIP/Postal Code
4920235
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
62748
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tel Hashomer
ZIP/Postal Code
52620
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Akita-shi
ZIP/Postal Code
010-8543
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Isehara-shi
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kawasaki-shi
ZIP/Postal Code
211-0063
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kitakyushu-shi
ZIP/Postal Code
802-0077
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Maebashi-shi
ZIP/Postal Code
371-8511
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Minato-ku
ZIP/Postal Code
105-8471
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Minato-ku
ZIP/Postal Code
108-8329
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Yamagata-shi
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Grafton
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Newtown
ZIP/Postal Code
6021
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Otahuhu
ZIP/Postal Code
2025
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lørenskog
ZIP/Postal Code
N-1478
Country
Norway
Individual Site Status
Recruiting
Facility Name
Research Site
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Name
Research Site
City
Oslo
ZIP/Postal Code
NO0424
Country
Norway
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Tromsø
ZIP/Postal Code
N-9038
Country
Norway
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ålesund
ZIP/Postal Code
6026
Country
Norway
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
04013
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Martin
ZIP/Postal Code
03601
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bilbao (Vizcaya)
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tomelloso
ZIP/Postal Code
13700
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
17164
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Trollhättan
ZIP/Postal Code
461 73
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Research Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Brighton
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Links:
URL
https://www.eoetrialandyou.com/en-US/selector/all
Description
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.
Learn more about this trial
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
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