Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05583227
Registration number
NCT05583227
Ethics application status
Date submitted
13/10/2022
Date registered
17/10/2022
Titles & IDs
Public title
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Query!
Scientific title
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING).
Query!
Secondary ID [1]
0
0
2022-001294-31
Query!
Secondary ID [2]
0
0
D5244C00001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CROSSING
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Eosinophilic Esophagitis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Allergies
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Tezepelumab
Treatment: Other - Tezepelumab
Other interventions - Placebo
Experimental: Tezepelumab Low Dose - Tezepelumab subcutaneous injections, in accessorised pre-filled syringes
Experimental: Tezepelumab High Dose - Tezepelumab subcutaneous injections, in accessorised pre-filled syringes
Placebo comparator: Placebo - Placebo subcutaneous injections, in accessorised pre-filled syringes
Treatment: Other: Tezepelumab
Tezepelumab subcutaneous injection
Treatment: Other: Tezepelumab
Tezepelumab subcutaneous injection
Other interventions: Placebo
Placebo subcutaneous injection
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Histologic response of peak esophageal eosinophil per HPF count of = 6 across all available esophageal levels
Query!
Assessment method [1]
0
0
Peak esophageal eosinophil count per HPF determined by histological analysis of 2-4 biopsies from each of the proximal, mid, and distal esophagus.
Query!
Timepoint [1]
0
0
Week 24
Query!
Primary outcome [2]
0
0
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 24
Query!
Secondary outcome [1]
0
0
Change from baseline in EoE EREFS (Endoscopic reference score )
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 24, Week 52
Query!
Secondary outcome [2]
0
0
Change from baseline in EoE-HSS (Histologic scoring system) grade score
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
Week 24
Query!
Secondary outcome [3]
0
0
Change from baseline in EoE-HSS (Histologic scoring system) stage score
Query!
Assessment method [3]
0
0
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).
Query!
Timepoint [3]
0
0
Week 24
Query!
Secondary outcome [4]
0
0
Histologic response of peak esophageal eosinophil per HPF count of = 6 across all available esophageal levels
Query!
Assessment method [4]
0
0
The peak esophageal eosinophil count is based on 2-4 esophageal biopsies from 2-3 locations.
Query!
Timepoint [4]
0
0
Week 52
Query!
Secondary outcome [5]
0
0
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Week 52
Query!
Secondary outcome [6]
0
0
Response of achieving clinico-histological remission
Query!
Assessment method [6]
0
0
Achieving pre-determined histologic and symptomatic remission thresholds.
Query!
Timepoint [6]
0
0
Week 24, Week 52
Query!
Eligibility
Key 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.
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/11/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
8/01/2027
Query!
Actual
Query!
Sample size
Target
360
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Elizabeth Vale
Query!
Recruitment hospital [2]
0
0
Research Site - Kogarah
Query!
Recruitment hospital [3]
0
0
Research Site - Mitcham
Query!
Recruitment hospital [4]
0
0
Research Site - South Brisbane
Query!
Recruitment hospital [5]
0
0
Research Site - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
5112 - Elizabeth Vale
Query!
Recruitment postcode(s) [2]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [3]
0
0
3132 - Mitcham
Query!
Recruitment postcode(s) [4]
0
0
QL 4101 - South Brisbane
Query!
Recruitment postcode(s) [5]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Iowa
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Massachusetts
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Michigan
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Jersey
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
North Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Ohio
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Pennsylvania
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
South Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Tennessee
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Texas
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Utah
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Virginia
Query!
Country [24]
0
0
Austria
Query!
State/province [24]
0
0
Graz
Query!
Country [25]
0
0
Austria
Query!
State/province [25]
0
0
Wels-Grieskirchen
Query!
Country [26]
0
0
Austria
Query!
State/province [26]
0
0
Wien
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Brugge
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Edegem
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Gent
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Leuven
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Botucatu
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Brasilia
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Caxias do Sul
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Curitiba
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Porto Alegre
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Sao Paulo
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
São José do Rio Preto
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Ontario
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Quebec
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Beijing
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Changsha
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Guangzhou
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Hangzhou
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Nanjing
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Shanghai
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Shenyang
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Tianjin
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Wuhan
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Zhengzhou
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Brno
Query!
Country [51]
0
0
Czechia
Query!
State/province [51]
0
0
Hradec Kralove
Query!
Country [52]
0
0
Czechia
Query!
State/province [52]
0
0
Praha
Query!
Country [53]
0
0
Denmark
Query!
State/province [53]
0
0
Aalborg
Query!
Country [54]
0
0
Denmark
Query!
State/province [54]
0
0
Køge
Query!
Country [55]
0
0
Denmark
Query!
State/province [55]
0
0
Odense
Query!
Country [56]
0
0
Finland
Query!
State/province [56]
0
0
Helsinki
Query!
Country [57]
0
0
Finland
Query!
State/province [57]
0
0
Hämeenlinna
Query!
Country [58]
0
0
Finland
Query!
State/province [58]
0
0
Kuopio
Query!
Country [59]
0
0
Finland
Query!
State/province [59]
0
0
Turku
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Frankfurt
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Landsberg
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
München
Query!
Country [63]
0
0
Greece
Query!
State/province [63]
0
0
Athens
Query!
Country [64]
0
0
Greece
Query!
State/province [64]
0
0
Thessaloniki
Query!
Country [65]
0
0
Israel
Query!
State/province [65]
0
0
Haifa
Query!
Country [66]
0
0
Israel
Query!
State/province [66]
0
0
Holon
Query!
Country [67]
0
0
Israel
Query!
State/province [67]
0
0
Jerusalem
Query!
Country [68]
0
0
Israel
Query!
State/province [68]
0
0
Petah Tikva
Query!
Country [69]
0
0
Israel
Query!
State/province [69]
0
0
Tel Aviv
Query!
Country [70]
0
0
Israel
Query!
State/province [70]
0
0
Tel Hashomer
Query!
Country [71]
0
0
Italy
Query!
State/province [71]
0
0
Bologna
Query!
Country [72]
0
0
Italy
Query!
State/province [72]
0
0
Milano
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Napoli
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Padova
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Pisa
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Roma
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Rozzano
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Verona
Query!
Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Akita-shi
Query!
Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Fukuoka-shi
Query!
Country [81]
0
0
Japan
Query!
State/province [81]
0
0
Himeji
Query!
Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Hiroshima-shi
Query!
Country [83]
0
0
Japan
Query!
State/province [83]
0
0
Isehara-shi
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Kawasaki-shi
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Kitakyushu-shi
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Maebashi-shi
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Minato-ku
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Osaka
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Shinjuku-ku
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Yamagata-shi
Query!
Country [91]
0
0
Netherlands
Query!
State/province [91]
0
0
Amsterdam
Query!
Country [92]
0
0
Netherlands
Query!
State/province [92]
0
0
Nijmegen
Query!
Country [93]
0
0
Netherlands
Query!
State/province [93]
0
0
Rotterdam
Query!
Country [94]
0
0
New Zealand
Query!
State/province [94]
0
0
Christchurch
Query!
Country [95]
0
0
New Zealand
Query!
State/province [95]
0
0
Grafton
Query!
Country [96]
0
0
New Zealand
Query!
State/province [96]
0
0
Hamilton
Query!
Country [97]
0
0
New Zealand
Query!
State/province [97]
0
0
Newtown
Query!
Country [98]
0
0
New Zealand
Query!
State/province [98]
0
0
Otahuhu
Query!
Country [99]
0
0
Norway
Query!
State/province [99]
0
0
Lørenskog
Query!
Country [100]
0
0
Norway
Query!
State/province [100]
0
0
Oslo
Query!
Country [101]
0
0
Norway
Query!
State/province [101]
0
0
Tromsø
Query!
Country [102]
0
0
Norway
Query!
State/province [102]
0
0
Ålesund
Query!
Country [103]
0
0
Slovakia
Query!
State/province [103]
0
0
Kosice
Query!
Country [104]
0
0
Slovakia
Query!
State/province [104]
0
0
Martin
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Barcelona
Query!
Country [106]
0
0
Spain
Query!
State/province [106]
0
0
Bilbao (Vizcaya)
Query!
Country [107]
0
0
Spain
Query!
State/province [107]
0
0
Madrid
Query!
Country [108]
0
0
Spain
Query!
State/province [108]
0
0
Pamplona
Query!
Country [109]
0
0
Spain
Query!
State/province [109]
0
0
Sevilla
Query!
Country [110]
0
0
Spain
Query!
State/province [110]
0
0
Tomelloso
Query!
Country [111]
0
0
Sweden
Query!
State/province [111]
0
0
Stockholm
Query!
Country [112]
0
0
Sweden
Query!
State/province [112]
0
0
Trollhättan
Query!
Country [113]
0
0
Sweden
Query!
State/province [113]
0
0
Uppsala
Query!
Country [114]
0
0
United Kingdom
Query!
State/province [114]
0
0
Brighton
Query!
Country [115]
0
0
United Kingdom
Query!
State/province [115]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Amgen
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT05583227
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-877-240-9479
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
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.
Query!
Available to whom?
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05583227