BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging (BURAN)

BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging Parameters

This study will assess the effects of benralizumab on airway dynamics in severe eosinophilic asthma in terms of quantitative computed tomography (CT)-derived measurements of pulmonary structure and function using the Functional Respiratory Imaging (FRI) platform.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Combination product: Benralizumab

Detailed Description

This is a phase IV, interventional single group, open-label, uncontrolled, prospective, multicenter clinical trial.

This study will be conducted in male and female participants ≥18 years old with established severe eosinophilic asthma as defined by European Respiratory Society (ERS)/American Thoracic Society (ATS) clinical guidelines inadequately controlled by treatment with Inhaled Corticosteroids-Long-acting β2 agonists (ICS-LABA) with or without oral corticosteroids (OCS) or other asthma controller medications.

Each participant will participate in the study for a minimum of 15 weeks and up to 23 weeks.

This study will comprise of:

Screening visit (V0) Visit 1 (V1; week 0; within 1 to 21 days of screening) Visit 2 (V2; week 4 ± 5 days) Visit 3 (V3; week 8 ± 5 days) Visit 4 (V4; week 13 ± 5 days) Follow-up (2 weeks [± 7 days] after V4) - Phone call follow-up. Participants will be discharged from the study after the phone call follow-up is completed.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Clayton, Australia, 3168
    • Research Site
  • Toorak Gardens, Australia, 5065
    • Research Site
• Belgium
  • Liege, Belgium, 4000
    • Research Site
  • Namur, Belgium, 5101
    • Research Site
• France
  • Montpellier Cedex 5, France, 34295
    • Research Site
• Portugal
  • Lisboa, Portugal, 1649-035
    • Research Site
  • Porto, Portugal, 4100-180
    • Research Site
• Spain
  • Barcelona, Spain, 08006
    • Research Site
  • Barcelona, Spain, 8003
    • Research Site
  • Barcelona, Spain, 08017
    • Research Site
  • Madrid, Spain, 28007
    • Research Site
  • Santander, Spain, 39008
    • Research Site
  • Villarreal (Castellón), Spain, 12540
    • Research Site
• United Kingdom
  • Bradford, United Kingdom, BND9 6RJ
    • Research Site
  • Nottingham, United Kingdom, NG5 1PB
    • Research Site
• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Research Site
  • Florida
    • Loxahatchee Groves, Florida, United States, 33470
      • Research Site
    • Plantation, Florida, United States, 33324
      • Research Site
  • Indiana
    • Greenwood, Indiana, United States, 46143
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Research Site
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Research Site
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Research Site
  • Texas
    • Tyler, Texas, United States, 75708
      • Research Site
    • Webster, Texas, United States, 77598
      • Research Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants who are diagnosed with asthma with documented reversibility post-bronchodilator or salbutamol either historical or at Visit 0 (V0).
• Participants who have documented treatment with ICS and LABA for ≥ 3 months prior to V0 with or without oral corticosteroids and additional asthma controllers.
• Participants who have documented peripheral blood eosinophil count ≥ 300 cells/μL at V0, or if Oral Corticosteroids (OCS)-dependent, a documented peripheral blood eosinophil count ≥ 150 cells/μL at V0.
• Participants who have had a minimum of 2 exacerbations in the last 12 months prior to V0.
• Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ≤ 70% at Visit 0 (V0).
• Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% of predicted at V0.
• Participants who can perform acceptable and repeatable spirometry.
• Participants who can withhold asthma maintenance medication for at least 12 hours prior to V0, 1 and 4 where spirometry and/or Computed Tomography (CT) scan procedures will be performed except for once-a-day dosage where 24 hours will be required.
• Female participants who have a negative pregnancy test prior to administration of the investigational product (IP) and high-resolution CT scan and must agree to use a highly effective method of birth control from randomization throughout the study duration and within 12 weeks after last dose of IP.

Exclusion Criteria:

• Participants who are unstable or who experienced an exacerbation/infection in the 6 weeks before V0.
• Participants with acute upper or lower airway infection in the 6 weeks before V0.
• Participants diagnosed with clinically important pulmonary disease other than asthma, or participants who have ever been diagnosed with pulmonary or systemic disease, other than asthma that are associated with elevated peripheral eosinophil count.
• Receipt of any biologic products for asthma within 4 months or 5 half-lives prior to V0 whichever is longer.
• History or current use of chronic (i.e., > 4 weeks) immunosuppressive medication.
• History of lung volume reduction surgery, lung resection, thermal bronchoplasty at any time before visit 0 (V0) or on active phase of pulmonary rehabilitation.
• Participants with current malignancy or history of malignancy.
• History of other clinically significant disease or abnormality.
• Participants with positive Hepatitis B, C or HIV.
• Participants with:

Positive COVID-19 test at V0, COVID-19 disease within 6 weeks before V0 or History of severe COVID-19 disease at any time, defined by the need for Intensive Care Unit stay or Mechanical Ventilation (invasive or non-invasive).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Benralizumab; Participants will receive 3 doses of benralizumab having a strength of 30 mg subcutaneously once every 4 weeks (Week 0, Week 4, and Week 8).	Combination product: Benralizumab; Participants will receive benralizumab subcutaneously.; Other Names: Fasenra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Untrimmed Total Mucus Volume at TLC	Change from baseline in airway dynamics after 13 weeks following treatment with benralizumab, using total mucus volume (specific airway volume) at total lung capacity (TLC) measurements from untrimmed airways was assessed.	Baseline and Week 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC	Change from baseline in untrimmed total mucus plugs score at TLC was assessed. Mucus plugs was scored with a scoring system similar to that by Dunican et al. with the Severe Asthma Research Program (SARP) based on bronchopulmonary segmental anatomy. The mucus score was calculated by counting the number of bronchopulmonary segments which contained 1 or more mucus plug, up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of the airway visible at TLC. Each bronchopulmonary segment is given a score of 1 (mucus plug[s] present) or 0 (mucus plug[s] absent). The segment scores of each lobe are summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-18. Higher scores indicate worse outcome.	Baseline and Week 13
Change From Baseline in Untrimmed Total Air Trapping at FRC	Change from baseline in untrimmed total air trapping at FRC was assessed.	Baseline and Week 13
Change From Baseline in Trimmed Distal Airway Wall Volume at TLC	Change from baseline in trimmed distal airway wall volume at TLC was assessed. Change from baseline in airway dynamics at Week 13 following treatment with benralizumab as measured by secondary FRI endpoints, irrespective of participants characteristics was assessed.	Baseline and Week 13
Change From Baseline in Untrimmed Distal Airway Volume at TLC	Change from baseline in untrimmed distal airway volume at TLC was assessed.	Baseline and Week 13
Change From Baseline in Untrimmed Distal Airway Volume at Functional Residual Capacity (FRC)	Change from baseline in untrimmed distal airway volume at FRC was assessed.	Baseline and Week 13
Change From Baseline in Untrimmed Total Lung Volume at TLC	Change from baseline in untrimmed total lung volume at TLC was assessed.	Baseline and Week 13
Change From Baseline in Untrimmed Total Lung Volume at FRC	Change from baseline in untrimmed total lung volume at FRC was assessed.	Baseline and Week 13
Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1)	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% confidence interval (CI) for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FEV1	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FEV1	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FEV1	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FEV1	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FEV1	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FEV1	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FEV1	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Vital Capacity (Pre-BD FVC)	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FVC	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FVC	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FVC	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FVC	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FVC	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FVC	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FVC	The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.	At Baseline (Week 0)
Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FEV1	The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FEV1).	Baseline and Week 13
Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FEV1	Relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FEV1). Mucus plugs was scored with a scoring system similar to that by Dunican et al. with SARP based on bronchopulmonary segmental anatomy. Mucus score was calculated by counting number of bronchopulmonary segments which contained 1 or more mucus plug, up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of airway visible at TLC. Each bronchopulmonary segment is given a score of 1 (mucus plug present) or 0 (mucus plug absent). The segment scores of each lobe are summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-18. Higher scores = worse outcome.	Baseline and Week 13
Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FEV1	The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FEV1).	Baseline and Week 13
Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FEV1	The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FEV1).	Baseline and Week 13
Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FEV1	The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FEV1).	Baseline and Week 13
Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FEV1	The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FEV1).	Baseline and Week 13
Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FVC	The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FVC).	Baseline and Week 13
Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FVC	Relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FVC). Mucus plugs was scored with a scoring system similar to that by Dunican et al. with SARP based on bronchopulmonary segmental anatomy. Mucus score was calculated by counting number of bronchopulmonary segments which contained 1 or more mucus plug, up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of airway visible at TLC. Each bronchopulmonary segment is given a score of 1 (mucus plug present) or 0 (mucus plug absent). The segment scores of each lobe are summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-18. Higher scores = worse outcome.	Baseline and Week 13
Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FVC	The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FVC).	Baseline and Week 13
Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FVC	The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FVC).	Baseline and Week 13
Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FVC	The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FVC).	Baseline and Week 13
Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FVC	The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FVC).	Baseline and Week 13
Number of Participants With Adverse Events (AEs)	The safety and tolerability of benralizumab was assessed.	From screening (Day -21) to follow-up (up to 1.9 years)

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• Redacted CSP
• Redacted CSR synopsis
• Redacted SAP

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): July 19, 2024
• Study Completion (Actual): July 19, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Benralizumab; Eosinophilic Asthma; BURAN; Inhaled Corticosteroids; Long-acting β2 agonists
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Asthma; Pulmonary Eosinophilia; Respiratory System Agents; Anti-Asthmatic Agents; Benralizumab
• Other Study ID Numbers: D3250R00107; 2022-000152-11 (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 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 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

Drug and device information, study documents

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