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Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)

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ClinicalTrials.gov Identifier: NCT03347279
Recruitment Status : Completed
First Posted : November 20, 2017
Results First Posted : November 26, 2021
Last Update Posted : November 26, 2021
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 9, 2017
First Posted Date  ICMJE November 20, 2017
Results First Submitted Date  ICMJE September 7, 2021
Results First Posted Date  ICMJE November 26, 2021
Last Update Posted Date November 26, 2021
Actual Study Start Date  ICMJE November 23, 2017
Actual Primary Completion Date September 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2021)
  • Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma [ Time Frame: From randomisation to Study Week 52. ]
    The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)
  • Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma in Subjects With Baseline Eosinophils < 300 Cells/uL [ Time Frame: From randomisation to Study Week 52. ]
    The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. This analysis is based on subjects with baseline eosinophils < 300 cells/uL
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
Annualized asthma exacerbation rate (AERR) [ Time Frame: Baseline to Week 52 ]
The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 52 weeks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2021)
  • Mean Change From Baseline at Week 52 in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) (L) (Key Secondary Endpoint) [ Time Frame: From randomisation to Study Week 52 ]
    Mean change from baseline in FEV1 as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
  • Mean Change From Baseline at Week 52 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score (Key Secondary Endpoint) [ Time Frame: From randomisation to Study Week 52 ]
    Mean change from baseline in AQLQ(S)+12 as compared to placebo at Week 52. The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).
  • Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6(ACQ-6) (Key Secondary Endpoint) [ Time Frame: From randomisation to Study Week 52 ]
    Change from baseline in ACQ-6 as compared to placebo at Week 52. The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
  • Mean Change From Baseline at Week 52 in Asthma Symptom Diary (Key Secondary Endpoint) [ Time Frame: From randomisation to Study Week 52 ]
    Mean change from baseline at Week 52 in Asthma Symptom Diary. The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4, where 0 indicates no asthma symptoms.
  • Time to First Asthma Exacerbation [ Time Frame: From randomisation to Study Week 52 ]
    Time to first occurrence of asthma exacerbation post-randomisation, presented as number of subjects with at least one asthma exacerbation as reported by the investigator in the eCRF.
  • Mean Change From Baseline at Week 52 in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb) [ Time Frame: From randomisation to Study Week 52 ]
    Mean change from baseline at Study Week 52 in FeNO (ppb) measured at site
  • Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52 [ Time Frame: From randomisation to Study Week 52 ]
    Daily rescue medication use is defined as: Number of night inhaler puffs + 2 x [number of night nebulizer times] + number of daytime inhaler puffs + 2 x [number of day nebulizer times]. Weekly means are calculated using at least 4 of 7 days of daily rescue medication use.
  • Mean Change From Baseline in Work Productivity Loss Due to Asthma at Week 52 [ Time Frame: From randomisation to Study Week 52 ]
    WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked.
  • Mean Change From Baseline in Class Productivity Loss Due to Asthma at Week 52 [ Time Frame: From randomisation to Study Week 52 ]
    WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Class productivity loss is derived by sum of percentage of missed class hours due to asthma and product of percentage of actual hours in class times degree of asthma affecting productivity while in class. Percentage of missed hours in class due to asthma is calculated by number of hours in class missed due to asthma divided by total number of hours in class missed plus number of hours actually in class.
  • Activity Impairment at Week 52 [ Time Frame: From randomisation to Study Week 52 ]
    WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Activity impairment is the degree health affected regular activities (other than work or class) rated from 0 to 10, with 0 meaning no effect, divided by 10, and then expressed as a percentage.
  • Pharmacokinetics of Tezepelumab [ Time Frame: Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, Week 64 ]
    Mean serum trough PK concentrations taken pre-dose at each visit
  • Mean Change From Baseline at Week 52 in EQ-5D-5L VAS [ Time Frame: At Study Week 52 ]
    Mean change from baseline at Study Week 52 in EQ-5D-5L VAS. EQ-5D-5L visual analogue scale (VAS) allows subjects to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.
  • Clinicians Global Impression of Change at Week 52 [ Time Frame: From randomisation to Study Week 52 ]
    CGIC (Clinical global impression of change) is an overall evaluation of response to treatment, conducted by investigator using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse)
  • Patients Global Impression of Change at Week 52 [ Time Frame: From randomisation to Study Week 52 ]
    PGIC (Patient global impression of change) is an overall evaluation of response to treatment, conducted by the patient using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse).
  • Patients Global Impression of Severity at Week 52 [ Time Frame: At Study Week 52 ]
    PGI-S (Patient global impression of severity) is an overall evaluation of patient's perception of overall symptom severity using a 6-point rating scale, ranging from 0 = No symptoms, 1=Very mild symptoms, 2=Mild symptoms, 3=Moderate symptoms, 4=Severe symptoms, 5=Very severe symptoms
  • Mean Change From Baseline at Week 52 in Blood Eosinophils (Cells/uL) [ Time Frame: From randomisation to Study Week 52 ]
    Mean change from baseline at Study Week 52 in blood eosinophils (cells/uL)
  • Mean Change From Baseline at Week 52 in Total Serum IgE (IU/mL) [ Time Frame: From randomisation to Study Week 52 ]
    Mean change from baseline at Study Week 52 in total serum IgE (IU/mL)
  • Number of Participants With Asthma Specific Healthcare Utilization Over 52 Weeks [ Time Frame: From randomisation to Study Week 52 ]
    Number of participants with asthma specific healthcare utilizations (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 52 weeks
  • Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 (Weekly Means) [ Time Frame: From randomisation to Study Week 52 ]
    Mean change from baseline in home based morning PEF (L/min) at Study Week 52. Home PEF testing will be performed by the subject in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Weekly means are calculated using at least 4 of the 7 days of PEF data.
  • Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 (Weekly Means) [ Time Frame: From randomisation to Study Week 52 ]
    Mean change from baseline in home based evening PEF (L/min) at Study Week 52. Home PEF testing will be performed by the subject in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Weekly means are calculated using at least 4 of the 7 days of PEF data.
  • Mean Change From Baseline in Night Time Awakenings (Weekly Means) at Week 52 [ Time Frame: From randomisation to Study Week 52 ]
    Mean change from baseline in night time awakenings due to asthma at Study Week 52. Night-time awakenings percentage defined as number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data and multiplied by 100%. At least 4 out of 7 days of data is required to calculate a weekly mean.
  • Immunogenecity of Tezepelumab [ Time Frame: Baseline, and from time of first dose at Week 0 to end of study at Week 64. ]
    Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. Treatment emergent ADA defined as sum of treatment induced ADA and treatment boosted ADA.
  • Proportion of Subjects Who Had no Asthma Exacerbations [ Time Frame: From randomisation to Study Week 52 ]
    The proportion of subjects who have no exacerbations is presented as the percentage of subjects with no exacerbations. This is defined as subjects who meet both the following criteria: (1) completed the 52 week treatment period and (2) did not report an exacerbation during this period.
  • Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalisation [ Time Frame: From randomisation to Study Week 52 ]
    The annualized exacerbation rate is based on exacerbations reported by the investigator that are associated with an emergency room visit, urgent care visit, or a hospitalization (where urgent care visit was captured as an emergency room visit on the eCRF)
  • Proportion of Subjects With at Least One Asthma Exacerbation Associated With Emergency Room Visit or Hospitalisation [ Time Frame: From randomisation to Study Week 52 ]
    Proportion of subjects with at least one asthma exacerbation associated with emergency room visit or hospitalisation as recorded by the investigator in the CRF. This is presented as percentage of subjects with at least one asthma exacerbation associated with emergency room visit or hospitalisation.
  • Proportion of Subjects Who Had no Asthma Exacerbations Associated With Emergency Room or Hospitalisation [ Time Frame: From randomisation to Study Week 52 ]
    The proportion of subjects with no exacerbations is presented as percentage of subjects who meet both the following criteria: (1) completed the 52 week treatment period and (2) did not report an exacerbation associated with emergency room or hospitalisation during this period.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline, Week 52 ]
    Change from baseline in FEV1 as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
  • Change from baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(S)+12) total score [ Time Frame: Baseline, Week 52 ]
    Change from baseline in AQLQ(S)+12 as compared to placebo at Week 52. The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).
  • Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) Score [ Time Frame: Baseline, Week 52 ]
    Change from baseline in ACQ-6 as compared to placebo at Week 52. The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
  • Change from baseline in weekly mean daily Asthma Symptom Diary score [ Time Frame: Baseline, Week 52 ]
    Change from baseline in Asthma Symptom Diary score as compared to placebo at Week 52. The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4.
  • Time to first asthma exacerbation [ Time Frame: Baseline to Week 52 ]
    Time to the first occurrence of asthma exacerbation post randomisation
  • Change from baseline in fractional exhaled nitric oxide FENO (ppb) [ Time Frame: Baseline, Week 52 ]
    Change from baseline in FeNO at week 52.
  • Change from baseline in weekly mean rescue medication use [ Time Frame: Baseline, Week 52 ]
    Change from baseline in weekly mean rescue medication use at Week 52. The number of rescue medication inhalations (puffs) and nebulizer treatments taken will be recorded by the subject in the Asthma Symptom Diary twice daily (i.e., in the morning and evening). Each timepoint is calculated as weekly means based on daily diary data.
  • Work Productivity and Activity Impairment (WPAI+CIQ) Questionnaire and Classroom Impairment Questionnaire score [ Time Frame: Baseline, Week 52 ]
    WPAI+CIQ score at Week 52. The WPAI+CIQ consists of questions about how asthma and asthma related issues impact a subject's ability to work, attend classes, and perform regular daily activities.
  • Serum trough concentrations [ Time Frame: Baseline to Week 52 ]
    Serum trough concentrations at each scheduled visit
  • European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) score [ Time Frame: Baseline, Week 52 ]
    EQ-5D at Week 52. The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems, and extreme problems) that reflect increasing levels of difficulty.
  • Patient Global Impression of Change/Severity (PGI-C, PGI-S) and Clinician Global Impression of Change (CGI-C) [ Time Frame: Baseline, Week 52 ]
    The CGI-C and the PGI-C are used to evaluate the overall response to treatment, and the assessments use a 7-point rating scale ranging from 1 (Very Much Improved) to 7 (Very Much Worse). PGI-S is a single item designed to capture the subject's perception of overall symptom severity using a 6-point categorical response scale (no symptoms to very severe symptoms)
  • Change from baseline in peripheral blood eosinophils [ Time Frame: Baseline, Week 52 ]
    Change from baseline in blood eosinophil counts at week 52.
  • Change from baseline in total serum IgE [ Time Frame: Baseline, Week 52 ]
    Change from baseline in IgE at week 52.
  • Asthma specific resource utilization (eg, unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) [ Time Frame: Baseline, Week 52 ]
    Number of asthma specific resource utilizations (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 52 weeks
  • Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) [ Time Frame: Baseline, Week 52 ]
    Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) at Week 52. Home PEF testing will be performed by the subject in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Each timepoint is calculated as weekly means.
  • Change from baseline in weekly mean number of night time awakenings [ Time Frame: Baseline, Week 52 ]
    Change from baseline in weekly mean number of night time awakenings at Week 52. Each timepoint is calculated as weekly mean number of awakenings due to asthma based on daily diary data.
  • Immunogenicity anti-drug antibodies and neutralizing antibodies [ Time Frame: Baseline to Week 52 ]
    Incidence of anti-drug antibodies and neutralizing antibodies over 64 weeks.
  • Proportion of subjects with >=1 asthma exacerbation [ Time Frame: Baseline to Week 52 ]
    Number and percentage of patients with at least one post randomisation asthma exacerbation
  • Annualized rate of exacerbations associated with emergency room visit, urgent care visit, or hospitalization [ Time Frame: Baseline to Week 52 ]
    The annualized exacerbation rate is based on exacerbations reported by the investigator that are associated with an emergency room visit, urgent care visit, or a hospitalization
Current Other Pre-specified Outcome Measures
 (submitted: October 29, 2021)
  • Annual Asthma Exacerbation Rate Associated With Hospitalisations [ Time Frame: From randomisation to Study Week 52 ]
    The annualized exacerbation rate is based on exacerbations reported by the investigator that are associated with hospitalization
  • Annual Asthma Exacerbation Rate Using Adjudicated Data [ Time Frame: From randomisation to Study Week 52 ]
    The annualized exacerbation rate is based on exacerbations as defined for the primary endpoint, but any hospitalisation and ER visits which are adjudicated to be asthma related are added, and those adjudicated to not be asthma related are removed from analyses.
  • Annual Asthma Exacerbation Rate Associated With Emergency Room (ER) Visit or Hospitalisation Using Adjudicated Data [ Time Frame: From randomisation to Study Week 52 ]
    The annualized exacerbation rate is based on exacerbations associated with hospitalisations or ER visits, where hospitalisation and ER visits adjudicated to be asthma related are added, and those adjudicated to not be asthma related are removed from analyses.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma
Official Title  ICMJE A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)
Brief Summary A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma
Detailed Description This is a multicentre, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 1060 subjects will be randomized globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-Blind
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Biological: Experimental: Tezepelumab
    Tezepelumab subcutaneous injection
    Other Name: Tezepelumab
  • Other: Placebo
    Placebo subcutaneous injection
Study Arms  ICMJE
  • Experimental: Tezepelumab
    Tezepelumab: Tezepelumab subcutaneous injection
    Intervention: Biological: Experimental: Tezepelumab
  • Placebo Comparator: Placebo
    Placebo: Placebo subcutaneous injection
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2020)
1061
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2017)
1060
Actual Study Completion Date  ICMJE November 12, 2020
Actual Primary Completion Date September 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age. 12-80
  • Documented physician-diagnosed asthma for at least 12 months
  • Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months.
  • Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
  • At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
  • Morning pre-BD FEV1 <80% predicted normal (<90% for subjects 12-17 yrs)
  • Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.
  • Documented history of at least 2 asthma exacerbation events within 12 months.
  • ACQ-6 score ≥1.5 at screening and on day of randomization

Exclusion Criteria:

  • Pulmonary disease other than asthma.
  • History of cancer.
  • History of a clinically significant infection.
  • Current smokers or subjects with smoking history ≥10 pack-years and subjects using vaping products, including electronic cigarettes.
  • History of chronic alcohol or drug abuse within 12 months.
  • Hepatitis B, C or HIV.
  • Pregnant or breastfeeding.
  • History of anaphylaxis following any biologic therapy.
  • Subject randomized in the current study or previous tezepelumab studies.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Brazil,   Canada,   France,   Germany,   Israel,   Japan,   Korea, Republic of,   Russian Federation,   Saudi Arabia,   South Africa,   Taiwan,   Ukraine,   United Kingdom,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03347279
Other Study ID Numbers  ICMJE D5180C00007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
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.
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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Amgen
Investigators  ICMJE
Principal Investigator: Andrew Menzies-Gow, MD Royal Brompton Hospital, United Kingdom
PRS Account AstraZeneca
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP