Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING)

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING).

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 Overview

• Status: Recruiting
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Other: Placebo; Biological: Tezepelumab

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.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com
• Study Contact Backup: Name: Carebox Healthcare Solutions Inc; Phone Number: 1-844-432-3890; Email: az-crossing@careboxhealth.com

Study Locations

• Australia
  • Elizabeth Vale, Australia, 5112
    • Recruiting
    • Research Site
  • Kogarah, Australia, 2217
    • Recruiting
    • Research Site
  • Mitcham, Australia, 3132
    • Recruiting
    • Research Site
  • South Brisbane, Australia, QL 4101
    • Recruiting
    • Research Site
  • Woolloongabba, Australia, 4102
    • Recruiting
    • Research Site
• Austria
  • Graz, Austria, 8036
    • Recruiting
    • Research Site
  • Wels-Grieskirchen, Austria, 4600
    • Recruiting
    • Research Site
  • Wien, Austria, 1090
    • Recruiting
    • Research Site
• Belgium
  • Brugge, Belgium, 8310
    • Recruiting
    • Research Site
  • Edegem, Belgium, 2650
    • Recruiting
    • Research Site
  • Gent, Belgium, 9000
    • Recruiting
    • Research Site
  • Leuven, Belgium, 3000
    • Recruiting
    • Research Site
• Brazil
  • Botucatu, Brazil, 18618-687
    • Recruiting
    • Research Site
  • Brasilia, Brazil, 71681-603
    • Recruiting
    • Research Site
  • Caxias do Sul, Brazil, 95070-560
    • Recruiting
    • Research Site
  • Curitiba, Brazil, 80440-220
    • Recruiting
    • Research Site
  • Curitiba, Brazil, 80250-060
    • Recruiting
    • Research Site
  • Porto Alegre, Brazil, 90035-903
    • Recruiting
    • Research Site
  • Porto Alegre, Brazil, 90050-170
    • Withdrawn
    • Research Site
  • Sao Paulo, Brazil, 05.403-010
    • Recruiting
    • Research Site
  • São José do Rio Preto, Brazil, 15090-000
    • Recruiting
    • Research Site
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1G5
      • Recruiting
      • Research Site
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • Research Site
    • Niagara Falls, Ontario, Canada, L2H 1H5
      • Recruiting
      • Research Site
    • Ottawa, Ontario, Canada, K1G 6C6
      • Recruiting
      • Research Site
    • Windsor, Ontario, Canada, N8X 2G1
      • Recruiting
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H4A 3T2
      • Recruiting
      • Research Site
• China
  • Beijing, China, 100020
    • Recruiting
    • Research Site
  • Beijing, China, 100050
    • Recruiting
    • Research Site
  • Changsha, China, 430033
    • Recruiting
    • Research Site
  • Guangzhou, China, 510080
    • Recruiting
    • Research Site
  • Guangzhou, China, 510515
    • Recruiting
    • Research Site
  • Hangzhou, China, 310052
    • Recruiting
    • Research Site
  • Nanjing, China, 2100008
    • Not yet recruiting
    • Research Site
  • Shanghai, China, 200025
    • Recruiting
    • Research Site
  • Shanghai, China, 200000
    • Recruiting
    • Research Site
  • Shenyang, China, 110004
    • Not yet recruiting
    • Research Site
  • Tianjin, China, 300052
    • Recruiting
    • Research Site
  • Wuhan, China, 430022
    • Recruiting
    • Research Site
  • Zhengzhou, China
    • Recruiting
    • Research Site
• Czechia
  • Brno, Czechia, 625 00
    • Recruiting
    • Research Site
  • Hradec Kralove, Czechia, 500 12
    • Recruiting
    • Research Site
  • Praha, Czechia, 190 00
    • Recruiting
    • Research Site
• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Research Site
  • Køge, Denmark, 4600
    • Recruiting
    • Research Site
  • Odense, Denmark, 5000
    • Recruiting
    • Research Site
• Finland
  • Helsinki, Finland, 00290
    • Recruiting
    • Research Site
  • Helsinki, Finland, 00290
    • Not yet recruiting
    • Research Site
  • Helsinki, Finland, 00100
    • Withdrawn
    • Research Site
  • Hämeenlinna, Finland, 13530
    • Withdrawn
    • Research Site
  • Kuopio, Finland, 70210
    • Recruiting
    • Research Site
  • Turku, Finland, 20520
    • Recruiting
    • Research Site
• Germany
  • Frankfurt, Germany, 60590
    • Not yet recruiting
    • Research Site
  • Landsberg, Germany, 86899
    • Withdrawn
    • Research Site
  • München, Germany, 81675
    • Recruiting
    • Research Site
  • München, Germany, 80337
    • Withdrawn
    • Research Site
• Greece
  • Athens, Greece, 12462
    • Recruiting
    • Research Site
  • Athens, Greece, 11527
    • Recruiting
    • Research Site
  • Athens, Greece, 11527, GR
    • Recruiting
    • Research Site
  • Athens, Greece, 11521
    • Recruiting
    • Research Site
  • Thessaloniki, Greece, 56429
    • Recruiting
    • Research Site
• Israel
  • Haifa, Israel, 31048
    • Recruiting
    • Research Site
  • Holon, Israel, 58100
    • Recruiting
    • Research Site
  • Jerusalem, Israel, 91120
    • Not yet recruiting
    • Research Site
  • Petah Tikva, Israel, 4920235
    • Recruiting
    • Research Site
  • Petah Tikva, Israel, 4941492
    • Recruiting
    • Research Site
  • Tel Aviv, Israel, 62748
    • Recruiting
    • Research Site
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Research Site
  • Tel Hashomer, Israel, 52620
    • Recruiting
    • Research Site
• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Research Site
  • Milano, Italy, 20162
    • Recruiting
    • Research Site
  • Napoli, Italy, 80131
    • Recruiting
    • Research Site
  • Napoli, Italy, 80131
    • Withdrawn
    • Research Site
  • Padova, Italy, 35128
    • Recruiting
    • Research Site
  • Pisa, Italy, 56124
    • Recruiting
    • Research Site
  • Roma, Italy, 00168
    • Recruiting
    • Research Site
  • Roma, Italy, 00161
    • Recruiting
    • Research Site
  • Rozzano, Italy, 20089
    • Recruiting
    • Research Site
  • Verona, Italy, 37134
    • Recruiting
    • Research Site
• Japan
  • Akita-shi, Japan, 010-8543
    • Recruiting
    • Research Site
  • Fukuoka-shi, Japan, 812-8582
    • Recruiting
    • Research Site
  • Hiroshima-shi, Japan, 734-8551
    • Not yet recruiting
    • Research Site
  • Isehara-shi, Japan, 259-1193
    • Recruiting
    • Research Site
  • Kawasaki-shi, Japan, 211-0063
    • Recruiting
    • Research Site
  • Kitakyushu-shi, Japan, 802-0077
    • Recruiting
    • Research Site
  • Maebashi-shi, Japan, 371-8511
    • Recruiting
    • Research Site
  • Minato-ku, Japan, 105-8471
    • Withdrawn
    • Research Site
  • Minato-ku, Japan, 108-8329
    • Recruiting
    • Research Site
  • Osaka, Japan, 545-8586
    • Recruiting
    • Research Site
  • Shinjuku-ku, Japan, 160-8582
    • Recruiting
    • Research Site
  • Shinjuku-ku, Japan, 162-8655
    • Not yet recruiting
    • Research Site
  • Yamagata-shi, Japan, 990-9585
    • Recruiting
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Recruiting
    • Research Site
  • Nijmegen, Netherlands, 6525 GA
    • Recruiting
    • Research Site
  • Rotterdam, Netherlands, 3015 GD
    • Recruiting
    • Research Site
• New Zealand
  • Grafton, New Zealand, 1023
    • Recruiting
    • Research Site
  • Hamilton, New Zealand, 3204
    • Recruiting
    • Research Site
  • Newtown, New Zealand, 6021
    • Recruiting
    • Research Site
  • Otahuhu, New Zealand, 2025
    • Recruiting
    • Research Site
• Norway
  • Lørenskog, Norway, 1478
    • Recruiting
    • Research Site
  • Lørenskog, Norway, N-1478
    • Recruiting
    • Research Site
  • Oslo, Norway, 0450
    • Recruiting
    • Research Site
  • Oslo, Norway, NO0424
    • Withdrawn
    • Research Site
  • Tromsø, Norway, N-9038
    • Recruiting
    • Research Site
  • Ålesund, Norway, 6026
    • Recruiting
    • Research Site
• Slovakia
  • Kosice, Slovakia, 04013
    • Recruiting
    • Research Site
  • Martin, Slovakia, 03601
    • Recruiting
    • Research Site
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08036
    • Recruiting
    • Research Site
  • Bilbao (Vizcaya), Spain, 48013
    • Withdrawn
    • Research Site
  • Madrid, Spain, 28007
    • Recruiting
    • Research Site
  • Madrid, Spain, 28006
    • Recruiting
    • Research Site
  • Madrid, Spain, 28031
    • Recruiting
    • Research Site
  • Pamplona, Spain, 31008
    • Recruiting
    • Research Site
  • Sevilla, Spain, 41013
    • Recruiting
    • Research Site
  • Sevilla, Spain, 41009
    • Recruiting
    • Research Site
  • Tomelloso, Spain, 13700
    • Recruiting
    • Research Site
• Sweden
  • Stockholm, Sweden, 171 76
    • Recruiting
    • Research Site
  • Stockholm, Sweden, 17164
    • Recruiting
    • Research Site
  • Trollhättan, Sweden, 461 73
    • Recruiting
    • Research Site
  • Uppsala, Sweden, 751 85
    • Recruiting
    • Research Site
• United Kingdom
  • Brighton, United Kingdom, BN2 1ES
    • Withdrawn
    • Research Site
  • London, United Kingdom, SW17 0QT
    • Not yet recruiting
    • Research Site
  • London, United Kingdom, WC1N 3JH
    • Not yet recruiting
    • Research Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Recruiting
      • Research Site
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
      • Research Site
  • Florida
    • Inverness, Florida, United States, 34452
      • Completed
      • Research Site
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Research Site
    • Saint Augustine, Florida, United States, 32086
      • Completed
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Withdrawn
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Withdrawn
      • Research Site
    • Normal, Illinois, United States, 61761
      • Recruiting
      • Research Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • Research Site
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Recruiting
      • Research Site
  • Maryland
    • White Marsh, Maryland, United States, 21162
      • Recruiting
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Research Site
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Recruiting
      • Research Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68503
      • Recruiting
      • Research Site
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Recruiting
      • Research Site
  • New York
    • Brooklyn, New York, United States, 11235
      • Recruiting
      • Research Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • Research Site
    • Winston-Salem, North Carolina, United States, 27157
      • Withdrawn
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Research Site
    • Smithfield, Pennsylvania, United States, 15478
      • Recruiting
      • Research Site
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Withdrawn
      • Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Research Site
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Research Site
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • Research Site
    • Salt Lake City, Utah, United States, 84107
      • Suspended
      • Research Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Withdrawn
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tezepelumab Low Dose; Tezepelumab subcutaneous injections, in accessorised pre-filled syringes	Biological: Tezepelumab; Tezepelumab subcutaneous injection
Experimental: Tezepelumab High Dose; Tezepelumab subcutaneous injections, in accessorised pre-filled syringes	Biological: Tezepelumab; Tezepelumab subcutaneous injection
Placebo Comparator: Placebo; Placebo subcutaneous injections, in accessorised pre-filled syringes	Other: Placebo; Placebo subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in peak esophageal eosinophil count (EOS/HPF)	The EOS/HPF is a method of evaluating esophageal inflammation by histological response of eosinophils per high power field (HPF).	Week 24, Week 52
Changes from baseline in PEESS Module at Week 24 (adolescents only).	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.	Week 24, Week 52
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. Extent (stage) of abnormalities is scored using a 4-point scale (0 normal; 3 maximum change).	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) of abnormalities is scored using a 4-point scale (0 normal; 3 maximum change).	Week 52
Serum tezepelumab concentration	PK samples will be collected pre-dose. Tezepelumab concentration in serum is determined using bioanalytical method.	Weeks 0, 4, 12, 24, and 52
Anti-drug antibody	Anti-drug antibody is determined using bioanalytical method.	Weeks 0, 12, 24, and 52

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Amgen

Publications and helpful links

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): January 8, 2027

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Eosinophilic Esophagitis; Eosinophilic; Chronic Esophagitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: D5244C00001; 2022-001294-31 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No