Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma (PONENTE)

May 9, 2023 updated by: AstraZeneca

PONENTE: A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients With Severe Eosinophilic Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy

This is a study designed to evaluate efficacy and safety of Benralizumab in reducing the Oral Corticosteroid (OCS) use in adult patients with severe asthma who are receiving OCS with or without additional asthma controller medications.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label, multicenter study designed to evaluate efficacy and safety of reducing daily oral corticosteroid (OCS) use after initiation of 30 mg dose of benralizumab administered subcutaneously (SC) in patients with severe eosinophilic asthma receiving high-dose inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) and OCS with or without additional asthma controller(s).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
598

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1121ABE
        • Research Site
      • Caba, Argentina, C1012AAR
        • Research Site
      • Cap. Fed, Argentina, 1280
        • Research Site
      • Ciudad Autónoma de Bs. As., Argentina, 1426
        • Research Site
      • Ciudad Autónoma de Buenos Aire, Argentina, C1440BRR
        • Research Site
      • Florencio Varela, Argentina, 1888
        • Research Site
      • Mar del Plata, Argentina, 7600
        • Research Site
      • Mendoza, Argentina, M5500GIP
        • Research Site
      • Monte Grande, Argentina, 1842
        • Research Site
      • Ranelagh, Argentina, 1886
        • Research Site
      • Rosario, Argentina, 2000
        • Research Site
      • Rosario, Argentina, S2000DEJ
        • Research Site
  • Belgium
      • Bruxelles, Belgium, 1200
        • Research Site
      • Erpent, Belgium, 5101
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
  • Brazil
      • Botucatu, Brazil, 18618-970
        • Research Site
      • Londrina, Brazil, 86057-970
        • Research Site
      • Maringa, Brazil, 87015-000
        • Research Site
      • Porto Alegre, Brazil, 90610-000
        • Research Site
      • Porto Alegre, Brazil, 91350-200
        • Research Site
      • Salvador, Brazil, 40060-330
        • Research Site
      • Santo Andre, Brazil, 09080-110
        • Research Site
      • Santo Andre, Brazil, 09060-650
        • Research Site
      • Sorocaba, Brazil, 18040-425
        • Research Site
      • Uberlandia, Brazil, 38411-186
        • Research Site
  • Canada
      • Quebec, Canada, G1V 4W2
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Research Site
    • CA
      • Vancouver, CA, Canada, V5Z 4E1
        • Research Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Research Site
      • Mississauga, Ontario, Canada, L5A 3V4
        • Research Site
      • Ottawa, Ontario, Canada, K1H 1E4
        • Research Site
      • Toronto, Ontario, Canada, M4V 1R2
        • Research Site
  • Colombia
      • Barranquilla, Colombia, 080020
        • Research Site
      • Bogota, Colombia, 110221
        • Research Site
      • Cali, Colombia, 76001000
        • Research Site
      • Cartagena, Colombia, 130013
        • Research Site
      • Floridablanca, Colombia, 681004
        • Research Site
      • Manizales, Colombia, 17001
        • Research Site
      • Medellin, Colombia, 5001000
        • Research Site
  • Denmark
      • Herlev, Denmark, 2730
        • Research Site
      • Hvidovre, Denmark, 2650
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
      • Ålborg, Denmark, 9000
        • Research Site
  • France
      • ANGERS Cedex 9, France, 49933
        • Research Site
      • Besancon Cedex, France, 25030
        • Research Site
      • Colmar Cedex, France, 68024
        • Research Site
      • Marseille, France, 13300
        • Research Site
      • NICE Cedex 01, France, 06001
        • Research Site
      • Orléans, France, 45067
        • Research Site
      • Reims, France, 51092
        • Research Site
      • Suresnes Cedex, France, 92151
        • Research Site
      • Tours, France, 37000
        • Research Site
  • Germany
      • Bamberg, Germany, 96049
        • Research Site
      • Berlin, Germany, 12203
        • Research Site
      • Berlin, Germany, 13187
        • Research Site
      • Darmstadt, Germany, 64283
        • Research Site
      • Frankfurt, Germany, 60596
        • Research Site
      • Großhansdorf, Germany, 22927
        • Research Site
      • Heidelberg, Germany, 69126
        • Research Site
      • Köln, Germany, 51069
        • Research Site
      • Leipzig, Germany, 04207
        • Research Site
      • Lübeck, Germany, 23552
        • Research Site
      • Magdeburg, Germany, 39120
        • Research Site
      • München, Germany, 81675
        • Research Site
  • Italy
      • Firenze, Italy, 50134
        • Research Site
      • Milano, Italy, 20162
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Palermo, Italy, 90129
        • Research Site
      • Pisa, Italy, 56100
        • Research Site
      • Roma, Italy, 00185
        • Research Site
      • Sassari, Italy, 07100
        • Research Site
      • Tradate, Italy, 21049
        • Research Site
  • Mexico
      • Del. Cuauhtemoc, Mexico, 06700
        • Research Site
      • Durango, Mexico, 43080
        • Research Site
      • Guadalajara, Mexico, 44130
        • Research Site
      • Guadalajara, Mexico, 44100
        • Research Site
      • Mérida, Mexico, 97070
        • Research Site
      • Veracruz, Mexico, 91910
        • Research Site
      • Villahermosa, Mexico, 86035
        • Research Site
  • Poland
      • Białystok, Poland, 15-044
        • Research Site
      • Białystok, Poland, 15-430
        • Research Site
      • Gdańsk, Poland, 80-214
        • Research Site
      • Kraków, Poland, 31-011
        • Research Site
      • Lubin, Poland, 59-300
        • Research Site
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Research Site
      • Poznań, Poland, 60-693
        • Research Site
      • Poznań, Poland, 60-823
        • Research Site
      • Rzeszów, Poland, 35-051
        • Research Site
      • Sosnowiec, Poland, 41-200
        • Research Site
      • Tarnów, Poland, 33-100
        • Research Site
      • Wieluń, Poland, 98-300
        • Research Site
      • Wrocław, Poland, 50-449
        • Research Site
  • Russian Federation
      • Izhevsk, Russian Federation, 426061
        • Research Site
      • Kirov, Russian Federation, 610014
        • Research Site
      • Moscow, Russian Federation, 115478
        • Research Site
      • Omsk, Russian Federation, 644043
        • Research Site
      • Omsk, Russian Federation, 644112
        • Research Site
      • Saint Petersburg, Russian Federation, 194354
        • Research Site
      • Saint Petersburg, Russian Federation, 195257
        • Research Site
      • Ulyanovsk, Russian Federation, 432009
        • Research Site
  • Spain
      • Cádiz, Spain, 11009
        • Research Site
      • Marbella (Málaga), Spain, 29603
        • Research Site
      • Mérida, Spain, 06800
        • Research Site
      • Ourense, Spain, 32005
        • Research Site
      • Sant Joan Despí (Barcelona), Spain, 08970
        • Research Site
      • Santiago De Compostela-Coruña, Spain, 15706
        • Research Site
      • Zaragoza, Spain, 50009
        • Research Site
  • Sweden
      • Lund, Sweden, 221 85
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Research Site
      • Kaohsiung Hsien, Taiwan, 83301
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Taipei, Taiwan, 235
        • Research Site
      • Taipei, Taiwan, 10449
        • Research Site
      • Taipei City, Taiwan, 110
        • Research Site
      • Yunlin, Taiwan, 640
        • Research Site
  • United Kingdom
      • Bradford, United Kingdom, BND9 6RJ
        • Research Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Research Site
      • London, United Kingdom, SW3 6HP
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Research Site
  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Research Site
    • California
      • Los Angeles, California, United States, 90025
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Research Site
    • Florida
      • Tampa, Florida, United States, 33607
        • Research Site
      • Winter Park, Florida, United States, 32789-4681
        • Research Site
    • Georgia
      • Albany, Georgia, United States, 31707
        • Research Site
      • Atlanta, Georgia, United States, 30322
        • Research Site
      • Savannah, Georgia, United States, 31405
        • Research Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • Research Site
    • Kentucky
      • Georgetown, Kentucky, United States, 40324
        • Research Site
      • Lakeside Park, Kentucky, United States, 41017
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Research Site
      • Saint Paul, Minnesota, United States, 55101
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63156
        • Research Site
    • New York
      • New York, New York, United States, 10016
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Research Site
      • Greenville, North Carolina, United States, 27834
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Research Site
      • Winston-Salem, North Carolina, United States, 27104
        • Research Site
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
        • Research Site
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 126 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Peripheral blood eosinophil count of ≥150 cells/μL assessed by central lab at Visit 1 or ≥ 300 cells/μL in the past 12 months
  2. History of physician diagnosed asthma requiring continuous treatment with high dose ICS (high-dose ICS is budesonide/formoterol HFA ≥640/18 per day or equivalent, fluticasone propionate DPI > 500/day or equivalent, or authorized generics for these products) plus LABA for at least 6 months prior to Visit 1. The ICS and LABA can be contained within a combination product or given by separate inhalers. The ICS can also be given via nebulized solution for inhalation.
  3. Chronic oral corticosteroid therapy equivalent to a daily dose of at least 5 mg of prednisone, for at least 3 continuous months directly preceding Visit 1.
  4. Patient should be on a stable OCS dose for at least 4 weeks prior to Visit 1.
  5. Non-smokers, current smokers or former smokers with a smoking history of < or =20 pack-years at Visit 1

Exclusion Criteria:

  1. Clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts
  2. Known history of allergy or reaction to the study drug formulation
  3. History of anaphylaxis to any biologic therapy
  4. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
  5. Asthma exacerbation requiring use of systemic corticosteroids, or an increase in maintenance dose of OCS, or acute upper/lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to Visit 2 (first benralizumab dose)
  6. A history of known immunodeficiency disorder including history of a positive human immunodeficiency virus (HIV) test
  7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 times the upper limit of normal (ULN) confirmed at Visit 1.
  8. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
  9. Coincident primary adrenal failure (Addison's disease) or irreversible secondary hypoadrenalism due to another independent cause (e.g. pituitary tumour or its treatment)
  10. Co-existent inflammatory conditions for which chronic OCS doses are part of their maintenance treatment such as Giant Cell Arteritis, Polymyalgia Rheumatica
  11. Exclusion from genetic research may be for any of the exclusion criteria specified in the main study or allogeneic bone marrow transplant, Non-leukocyte depleted whole blood transfusion within 120 days of genetic sample collection
  12. Current night-shift workers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Benralizumab
Benralizumab subcutaneous injection
Biological: Benralizumab
Benralizumab subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patients Who Achieve 100% Reduction in Daily OCS Dose
Time Frame: Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Patients who achieve 100% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma
Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Patients Who Achieve 100% Reduction or a Daily OCS Dose of <=5mg
Time Frame: Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Patients who achieve 100% reduction or a daily OCS dose of <=5mg, if reason for no further OCS reduction is Adrenal Insufficiency, that are sustained over at least 4 weeks without worsening of asthma
Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients Who Achieve a Daily OCS of ≤5mg
Time Frame: Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Patients who achieve a daily OCS dose of ≤5 mg (regardless of reason for no further OCS reduction), that are sustained over at least 4 weeks without worsening of asthma
Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Patients Who Achieve a ≥90%, ≥75%, and ≥50% Reduction in Daily OCS Dose
Time Frame: Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Patients who achieve a ≥90%, ≥75%, and ≥50% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma
Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Change From Baseline in Average Daily OCS Dose (mg)
Time Frame: Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)
Change from baseline in average daily OCS dose (mg) from start of OCS reduction to end of the OCS reduction phase
Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients Who Achieve 100% Reduction in Daily OCS Dose From Main Study Baseline OCS Dose to the End of the Long Term Follow up Substudy
Time Frame: from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days.
Patients who achieve 100% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma
from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days.
Patients Who Achieve a Daily OCS Dose of ≤5 mg at the End of the Long Term Follow up Substudy
Time Frame: from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days.
Patients who achieve a daily OCS dose of ≤5 mg (regardless of reason for no further OCS reduction), that are sustained over at least 4 weeks without worsening of asthma
from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days.
Patients Who Achieve ≥90%, ≥75%, ≥50% or >0% OCS Reduction From Main Study Baseline OCS Dose to the End of the Long Term Follow up Substudy
Time Frame: from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days.
Patients who achieve a ≥90%, ≥75%, and ≥50% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma
from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days.
Change in Daily OCS Dose (mg) From Main Study Baseline to the End of the Long Term Follow up Substudy
Time Frame: from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days.
Change in average daily OCS dose (mg) from main study baseline to the end of the long term follow up substudy
from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3250C00065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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