Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment (BRISOTE)

BRISOTE: A Multicentre, Randomised, Double-Blind, Parallel Group, Active-Controlled, Phase 3b Study to Evaluate the Efficacy and Safety of Benralizumab 30 mg SC in Eosinophilic Asthma Patients Uncontrolled on Medium-Dose Inhaled Corticosteroid Plus Long-acting β2-Agonist.

This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.

Study Overview

• Status: Recruiting
• Conditions: Eosinophilic Asthma
• Intervention / Treatment: Combination product: ICS-LABA; Combination product: benralizumab; Combination product: Placebo for Benralizumab

Detailed Description

This is a randomized, double-blind, active-controlled, parallel group global study designed to investigate the efficacy and safety of adding fixed-dose benralizumab (30 mg), administered subcutaneously (SC) every 4 weeks for the first 3 doses and then every 8 weeks for participants with a history of eosinophilic asthma, who remain uncontrolled on medium-dose Inhaled corticosteroid-Long-acting β2-agonists (ICS-LABA) with or without other asthma controller(s) (with the exception of oral corticosteroids), compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA plus placebo (benralizumab).

• Study Type: Interventional
• Enrollment (Estimated): 400
• 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 Locations

• Bulgaria
  • Dimitrovgrad, Bulgaria, 6400
    • Not yet recruiting
    • Research Site
  • Haskovo, Bulgaria, 6300
    • Not yet recruiting
    • Research Site
  • Pleven, Bulgaria, 5800
    • Not yet recruiting
    • Research Site
  • Plovdiv, Bulgaria, 4023
    • Not yet recruiting
    • Research Site
  • Plovdiv, Bulgaria, 4002
    • Recruiting
    • Research Site
  • Rousse, Bulgaria, 7002
    • Recruiting
    • Research Site
  • Sofia, Bulgaria, 1431
    • Recruiting
    • Research Site
  • Sofia, Bulgaria, 1142
    • Recruiting
    • Research Site
  • Stara Zagora, Bulgaria, 6000
    • Recruiting
    • Research Site
  • Stara Zagora, Bulgaria, 6000
    • Not yet recruiting
    • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2C8
      • Withdrawn
      • Research Site
  • British Columbia
    • Kamloops, British Columbia, Canada, V2C 5T1
      • Recruiting
      • Research Site
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Recruiting
      • Research Site
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
      • Recruiting
      • Research Site
    • Toronto, Ontario, Canada, M5T 3A9
      • Recruiting
      • Research Site
    • Windsor, Ontario, Canada, N8X 1T3
      • Recruiting
      • Research Site
  • Quebec
    • Québec, Quebec, Canada, G1G 3Y8
      • Recruiting
      • Research Site
    • Sainte-Foy, Quebec, Canada, G1V 4G5
      • Recruiting
      • Research Site
• China
  • Beijing, China, 100020
    • Recruiting
    • Research Site
  • Beijing, China, 100044
    • Recruiting
    • Research Site
  • Beijing, China, 102218
    • Recruiting
    • Research Site
  • Changsha, China, 410004
    • Recruiting
    • Research Site
  • Chongqing, China, 400042
    • Recruiting
    • Research Site
  • Fuzhou, China, 350001
    • Not yet recruiting
    • Research Site
  • Fuzhou, China, 350005
    • Not yet recruiting
    • Research Site
  • Fuzhou, China, 350008
    • Recruiting
    • Research Site
  • Guangzhou, China, 510120
    • Recruiting
    • Research Site
  • Guangzhou, China, 510180
    • Recruiting
    • Research Site
  • Hangzhou, China, 310014
    • Recruiting
    • Research Site
  • Hangzhou, China, 31000
    • Recruiting
    • Research Site
  • Hefei, China, 230061
    • Recruiting
    • Research Site
  • Huizhou, China, 516002
    • Recruiting
    • Research Site
  • Jinan, China, 250021
    • Recruiting
    • Research Site
  • Linyi, China, 276100
    • Not yet recruiting
    • Research Site
  • Ningbo, China, 315020
    • Recruiting
    • Research Site
  • Qinhuangdao, China
    • Recruiting
    • Research Site
  • Shanghai, China, 200080
    • Recruiting
    • Research Site
  • Shanghai, China, 200433
    • Recruiting
    • Research Site
  • Wenzhou, China, 325027
    • Recruiting
    • Research Site
  • Wuhan, China, 430030
    • Recruiting
    • Research Site
  • Xuzhou, China, 221000
    • Recruiting
    • Research Site
  • Yinchuan, China, 750004
    • Recruiting
    • Research Site
  • Zhengzhou, China, 450000
    • Recruiting
    • Research Site
• France
  • Bayonne, France, 64109
    • Recruiting
    • Research Site
  • Créteil, France, 94010
    • Recruiting
    • Research Site
  • La Tronche, France, 38043
    • Recruiting
    • Research Site
  • Lyon, France, 69317
    • Recruiting
    • Research Site
  • Montpellier, France, 34295
    • Recruiting
    • Research Site
  • Pessac, France, F-33604
    • Recruiting
    • Research Site
  • Suresnes, France, 92150
    • Recruiting
    • Research Site
  • Toulouse, France, 31059
    • Recruiting
    • Research Site
  • Villeurbanne, France, 69100
    • Recruiting
    • Research Site
• Germany
  • Berlin, Germany, 10717
    • Recruiting
    • Research Site
  • Berlin, Germany, 10367
    • Recruiting
    • Research Site
  • Bonn, Germany, 53119
    • Not yet recruiting
    • Research Site
  • Cottbus, Germany, 03050
    • Recruiting
    • Research Site
  • Delitzsch, Germany, 4509
    • Withdrawn
    • Research Site
  • Frankfurt am Main, Germany, 60389
    • Not yet recruiting
    • Research Site
  • Geesthacht, Germany, 21502
    • Recruiting
    • Research Site
  • Hemer, Germany, 58675
    • Not yet recruiting
    • Research Site
  • Landsberg, Germany, 86899
    • Not yet recruiting
    • Research Site
  • Langen, Germany, 63225
    • Not yet recruiting
    • Research Site
  • Lübeck, Germany, 23552
    • Recruiting
    • Research Site
  • Mönchengladbach, Germany, 41063
    • Not yet recruiting
    • Research Site
  • München, Germany, 81377
    • Suspended
    • Research Site
  • München-Pasing, Germany, 81241
    • Not yet recruiting
    • Research Site
  • Neu-Isenburg, Germany, 63263
    • Not yet recruiting
    • Research Site
  • Wiesbaden, Germany, 65183
    • Recruiting
    • Research Site
  • Witten, Germany, 58452
    • Not yet recruiting
    • Research Site
  • Zossen, Germany, 15806
    • Not yet recruiting
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Withdrawn
    • Research Site
  • Pok Fu Lam, Hong Kong, 999077
    • Recruiting
    • Research Site
  • Shatin, Hong Kong, 0000
    • Recruiting
    • Research Site
• Ireland
  • Ballinasloe, Ireland, H53 T971
    • Recruiting
    • Research Site
  • Cork, Ireland, T12 DFK4
    • Recruiting
    • Research Site
  • Dublin, Ireland, D15 X40D
    • Recruiting
    • Research Site
  • Moneymore, Ireland, A92 VW28
    • Recruiting
    • Research Site
• Italy
  • Bari, Italy, 70124
    • Not yet recruiting
    • Research Site
  • Bergamo, Italy, 24127
    • Recruiting
    • Research Site
  • Brescia, Italy, 25123
    • Recruiting
    • Research Site
  • Cagliari, Italy, 09122
    • Recruiting
    • Research Site
  • Catanzaro, Italy, 88100
    • Recruiting
    • Research Site
  • Genoa, Italy, 16132
    • Recruiting
    • Research Site
  • Milan, Italy, 20122
    • Recruiting
    • Research Site
  • Modena, Italy, 41124
    • Withdrawn
    • Research Site
  • Montebelluna, Italy, 31044
    • Recruiting
    • Research Site
  • Naples, Italy, 80131
    • Recruiting
    • Research Site
  • Roma, Italy, 00168
    • Recruiting
    • Research Site
  • Roma, Italy, 00161
    • Recruiting
    • Research Site
  • Rozzano, Italy, 20089
    • Recruiting
    • Research Site
  • Verona, Italy, 37124
    • Recruiting
    • Research Site
• Norway
  • Lørenskog, Norway, N-1478
    • Recruiting
    • Research Site
• Spain
  • Alcorcón, Spain, 28922
    • Recruiting
    • Research Site
  • Alzira (Valencia), Spain, 46600
    • Recruiting
    • Research Site
  • Badalona, Spain, 08916
    • Recruiting
    • Research Site
  • Barakaldo, Spain, 48902
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08035
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08025
    • Recruiting
    • Research Site
  • Burgos, Spain, 09006
    • Recruiting
    • Research Site
  • Cáceres, Spain, 10003
    • Recruiting
    • Research Site
  • Granada, Spain, 18014
    • Recruiting
    • Research Site
  • Jerez de la Frontera, Spain, 11407
    • Recruiting
    • Research Site
  • Lugo, Spain, 27003
    • Recruiting
    • Research Site
  • Madrid, Spain, 28050
    • Not yet recruiting
    • Research Site
  • Madrid, Spain, 28034
    • Recruiting
    • Research Site
  • Madrid, Spain, 28041
    • Recruiting
    • Research Site
  • Marbella, Spain, 29603
    • Recruiting
    • Research Site
  • Marbella, Spain, 29600
    • Recruiting
    • Research Site
  • Málaga, Spain, 29010
    • Recruiting
    • Research Site
  • Mérida, Spain, 06800
    • Recruiting
    • Research Site
  • Palma de Mallorca, Spain, 7120
    • Recruiting
    • Research Site
  • Santander, Spain, 39008
    • Recruiting
    • Research Site
• Switzerland
  • Aarau, Switzerland, 5001
    • Recruiting
    • Research Site
  • Basel, Switzerland, 4031
    • Recruiting
    • Research Site
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Research Site
  • Sankt Gallen, Switzerland, 9007
    • Recruiting
    • Research Site
  • Sion, Switzerland, 1951
    • Recruiting
    • Research Site
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Recruiting
    • Research Site
  • Birmingham, United Kingdom, B9 5SS
    • Recruiting
    • Research Site
  • Bradford, United Kingdom, BD9 6RJ
    • Recruiting
    • Research Site
  • Bristol, United Kingdom, BS10 5NB
    • Recruiting
    • Research Site
  • Chorley, United Kingdom, PR7 1PP
    • Recruiting
    • Research Site
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • Research Site
  • Liverpool, United Kingdom, L7 8XP
    • Not yet recruiting
    • Research Site
  • Nottingham, United Kingdom, NG7 2UH
    • Withdrawn
    • Research Site
  • Portsmouth, United Kingdom, PO6 3LY
    • Withdrawn
    • Research Site
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Withdrawn
      • Research Site
    • Sun City, Arizona, United States, 85351
      • Recruiting
      • Research Site
    • Tucson, Arizona, United States, 85704
      • Recruiting
      • Research Site
  • California
    • Bakersfield, California, United States, 93301
      • Not yet recruiting
      • Research Site
    • Inglewood, California, United States, 90301
      • Recruiting
      • Research Site
    • Modesto, California, United States, 95355
      • Not yet recruiting
      • Research Site
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Research Site
    • Pasadena, California, United States, 91101
      • Recruiting
      • Research Site
  • Colorado
    • Denver, Colorado, United States, 80206
      • Withdrawn
      • Research Site
  • Florida
    • Cape Coral, Florida, United States, 33990
      • Recruiting
      • Research Site
    • Hialeah, Florida, United States, 33015
      • Not yet recruiting
      • Research Site
    • Lauderdale Lakes, Florida, United States, 33313
      • Recruiting
      • Research Site
    • Leesburg, Florida, United States, 34748
      • Recruiting
      • Research Site
    • Miami, Florida, United States, 33155
      • Not yet recruiting
      • Research Site
    • Miami, Florida, United States, 33175
      • Recruiting
      • Research Site
    • Miami, Florida, United States, 33122
      • Not yet recruiting
      • Research Site
    • Orlando, Florida, United States, 32819
      • Recruiting
      • Research Site
    • Plantation, Florida, United States, 33324
      • Not yet recruiting
      • Research Site
    • Tampa, Florida, United States, 33607
      • Recruiting
      • Research Site
    • Winter Park, Florida, United States, 32789
      • Recruiting
      • Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • Research Site
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Recruiting
      • Research Site
  • New Jersey
    • Northfield, New Jersey, United States, 08225
      • Recruiting
      • Research Site
    • Union City, New Jersey, United States, 07087
      • Not yet recruiting
      • Research Site
  • New York
    • New Hyde Park, New York, United States, 11042
      • Recruiting
      • Research Site
    • The Bronx, New York, United States, 10459
      • Recruiting
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Withdrawn
      • Research Site
    • Oklahoma City, Oklahoma, United States, 73111
      • Recruiting
      • Research Site
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Recruiting
      • Research Site
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Recruiting
      • Research Site
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • Research Site
  • Texas
    • Houston, Texas, United States, 77099
      • Not yet recruiting
      • Research Site
    • McKinney, Texas, United States, 75069
      • Recruiting
      • Research Site
    • San Antonio, Texas, United States, 78251
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Written informed consent
• Participant must be 12 to 75 years of age
• Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit (V) 1.
• Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids).
• Weight of ≥ 35 kg.
• Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted
• Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent.
• ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3.
• Evidence of asthma as documented by excessive variability in lung function, as defined in the protocol.
• Peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol.
• At least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary.

Exclusion Criteria:

• Important pulmonary disease other than asthma at the discretion of the investigator, or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts.
• Asthma exacerbation requiring use of Systemic corticosteroids (SCS), or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
• Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol.
• Clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator's discretion)
• Concurrent participation in another clinical study with an IP or a post-authorisation safety study.
• History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
• Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medium-dose ICS-LABA + benralizumab; Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks.	Combination product: ICS-LABA; ICS-LABA inhalation; Combination product: benralizumab; Benralizumab. SC injection.
Active Comparator: High-dose ICS-LABA + placebo; Participants will be randomised 1:1 to one of the 2 study arms. Participants will receive up to 7 SC injections during study, with the first 3 doses administered every 4 weeks and then subsequent doses every 8 weeks.	Combination product: ICS-LABA; ICS-LABA inhalation; Combination product: Placebo for Benralizumab; Placebo for Benralizumab (aka, "placebo"). SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized asthma exacerbation rate	To assess asthma exacerbation rate.	Baseline through Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Saint George's Respiratory Questionnaire (SGRQ) total score	The SGRQ is a 50-item ePRO instrument developed to measure the health status of participants with airway obstruction disease. The questionnaire is divided into 2 parts: Part 1 consists of 8 items that pertain to the severity of respiratory symptoms in the preceding 4 weeks, and Part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yields a total score and 3 component scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. This total score ranges from 0 to 100 with 0 indicating the best possible health status and 100 representing the worst possible health status	Baseline through Week 48
Change in pre-bronchodilator FEV1	Lung function is assessed by FEV1 which was measured by spirometry. Spirometry will be performed by the Investigator or authorized delegate according to American Thoracic Society /European Respiratory Society guidelines.	Baseline through Week 48
Change in Asthma control questionnaire (ACQ) scale score.	The ACQ-6 is a shortened version of the full 7-item ACQ questionnaire, which assesses asthma symptoms (nighttime awakening, symptoms on awakening, activity limitation, shortness of breath, wheezing, SABA use) but omits the FEV1 measurement from the original ACQ-7 assessment. Participants are asked to recall how their asthma has been during the previous week by responding to 6 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The total ACQ-6 score is the mean of the responses. The effect of benralizumab will be evaluated with the change from baseline in ACQ-6 to End of treatment (week 48) and over the treatment period.	Baseline through Week 48.
Time to first asthma exacerbation	Time to the first occurrence of asthma exacerbation post randomisation.	Baseline through Week 48.
Annualized asthma exacerbation rate associated with an emergency/urgent care visit or a hospitalization	The annualized exacerbation rate is based on unadjudicated exacerbation reported by the investigator that are associated with an emergency room/urgent care visit or a hospitalization adjusted by the time of follow-up.	Baseline through Week 48.
Number and proportion of participants that meet each component of a 4-component clinical remission composite	Number and proportion of participants that meet each component of a 4-component clinical remission composite (no exacerbations; no mOCS use; ACQ-6 < 1.5); and stable FEV1 (defined as change from baseline in FEV1 > -100 mL) at Week 24 and EOT.; Number and proportion of participants that meet 0, 1, 2, 3 and all 4 components of the composite remission endpoint at Week 24 and EOT.	Week 24 and Week 48.
Safety Adverse Event (AEs), Serious Adverse Event (SAEs), Adverse event leading to treatment discontinuation (DAEs.)		Baseline through Week 48.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Sady Alpizar, MD, Clinical Research Trials of Florida, Inc.; Principal Investigator: Sandeep Bansal, MD, Clinical Research Associates of Central PA; Principal Investigator: Muhammad Salim, MD, Chandler Clinical Trials; Principal Investigator: Jose Diaz, MD, Flourish Research - Leesburg; Principal Investigator: Ryan Klein, MD, NewportNativeMD, Inc.; Principal Investigator: Rohit Katial, MD, National Jewish Health; Principal Investigator: Vikas Sayal, MD, Henderson Clinical Trials, LLC; Principal Investigator: Jeremy Cole, MD, IPS Research Company; Principal Investigator: Shahrukh Kureishy, MD, Metroplex Pulmonary and Sleep Center; Principal Investigator: John Zwetchkenbaum, MD, AAPRI Clinical Research Institute; Principal Investigator: Erika Gonzalez, MD, South Texas Allergy & Asthma Medical Professionals (STAAMP); Principal Investigator: Mila Leong, MD, Pediatric Pulmonary & Asthma Associates of South Jersey, LLC; Principal Investigator: Alfonso Gonzalez-Rodriguez, MD, Florida Premier Research Institute - Clay Street; Principal Investigator: Njira Lugogo, MD, University of Michigan Health System - A. Alfred Taubman Health Care Center - Pulmonary Clinic; Principal Investigator: Samuel DeLeon, MD, Urban Health Plan; Principal Investigator: Juan Rodriguez, MD, Sun City Clinical Research; Principal Investigator: Neil Kao, MD, Allergic Disease & Asthma Center, P.A. (ADAC) - Butler Road Office; Principal Investigator: Charles Lunn, MD, Lynn Health Science Institute East; Principal Investigator: Mina Makaryus, MD, Northwell Health - Centers for Advanced Medicine; Principal Investigator: Tzu-Jen Tzao, MD, Pasadena Clinical Trials; Principal Investigator: Dena Petersen, MD, Noble Clinical Research - Elite Clinical Network; Principal Investigator: Patel Paryus, MD, Prime Healthcare - Inglewood; Principal Investigator: Marvin Heuer, MD, Heuer M.D. Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Estimated): November 3, 2028
• Study Completion (Estimated): November 3, 2028

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Eosinophilic Asthma;; Benralizumab,; FASENRA,; Medium-Dose Inhaled Corticosteroid,; Long-acting β2-Agonist
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pulmonary Eosinophilia; Respiratory System Agents; Anti-Asthmatic Agents; benralizumab
• Other Study ID Numbers: D3250C00101

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 Vivli.org. All requests 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 PhRMA 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 anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• 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