Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)

March 28, 2024 updated by: AstraZeneca

A Multicentre, Randomised, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma.

This is a randomised, double-blind, parallel group, placebo-controlled study designed to evaluate the efficacy and safety of a fixed 30 mg dose of benralizumab administered subcutaneously for patients with a history of asthma exacerbations and uncontrolled asthma receiving medium to high-dose inhaled corticosteroid plus long-acting β2-agonist (ICS-LABA) with or without oral corticosteroids and additional asthma controllers.

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

Approximately 666 patients will be randomised. Patients will be stratified by country/region, age group (adult or adolescent), and peripheral blood eosinophil count at time of Visit 1 (<300 or ≥300 cells/μL).All the patients will be randomised to either placebo or benralizumab (1:1 ratio) for a 48-weeks treatment, every 4 weeks for the first 3 doses and then every 8 weeks thereafter.

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.
695

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

  • China
      • Baotou, China, 14010
        • Research Site
      • Beijing, China, 100020
        • Research Site
      • Beijing, China, 100730
        • Research Site
      • Beijing, China, 100034
        • Research Site
      • Beijing, China, 100037
        • Research Site
      • Beijing, China, 100050
        • Research Site
      • Changsha, China, 410004
        • Research Site
      • Changsha, China, 410015
        • Research Site
      • Changzhi, China, 46000
        • Research Site
      • Chengdu, China, 610041
        • Research Site
      • Chengdu, China, 611130
        • Research Site
      • Chongqing, China, 400038
        • Research Site
      • Foshan, China, 528000
        • Research Site
      • Ganzhou, China, 341000
        • Research Site
      • Guangzhou, China, 510120
        • Research Site
      • Guangzhou, China, 510150
        • Research Site
      • Guangzhou, China, 510080
        • Research Site
      • Guangzhou, China, 510180
        • Research Site
      • Guiyang, China, 550004
        • Research Site
      • Haikou, China, 570311
        • Research Site
      • Hangzhou, China, 310006
        • Research Site
      • Hangzhou, China, 310003
        • Research Site
      • Hangzhou, China, 310009
        • Research Site
      • Hangzhou, China, 310014
        • Research Site
      • Hohhot, China, 010017
        • Research Site
      • Hohhot, China, 10050
        • Research Site
      • Jining, China, 272029
        • Research Site
      • Kunming, China, 650032
        • Research Site
      • Kunming, China, 650051
        • Research Site
      • Lishui, China, 323000
        • Research Site
      • Nanchang, China, 330006
        • Research Site
      • Nanjing, China, 2100008
        • Research Site
      • Nanjing, China, 210009
        • Research Site
      • Nanjing, China, 210029
        • Research Site
      • Neijiang, China, 641000
        • Research Site
      • Qingdao, China, 110016
        • Research Site
      • Qingdao, China, 266000
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 200433
        • Research Site
      • Shanghai, China, 200025
        • Research Site
      • Shanghai, China, 200072
        • Research Site
      • Shanghai, China, 201199
        • Research Site
      • Shenyang, China, 110001
        • Research Site
      • Shenyang, China, 110015
        • Research Site
      • Taiyuan, China, 030001
        • Research Site
      • Taizhou, China, 225300
        • Research Site
      • Wanzhou, China, 404000
        • Research Site
      • Wuhan, China, 430030
        • Research Site
      • Xiangtan, China, 411100
        • Research Site
      • Xinxiang, China, 453002
        • Research Site
      • Xuzhou, China, 221006
        • Research Site
      • Xuzhou, China, 221009
        • Research Site
      • Yangzhou, China, 225001
        • Research Site
      • Yinchuan, China, 750001
        • Research Site
      • Yinchuan, China, 750004
        • Research Site
      • Zhanjiang, China, 524001
        • Research Site
      • Zhuhai, China, 519099
        • Research Site
      • Zunyi, China, 563100
        • Research Site
  • Korea, Republic of
      • Bucheon-si, Korea, Republic of, 14584
        • Research Site
      • Busan, Korea, Republic of, 49241
        • Research Site
      • Cheonan, Korea, Republic of, 330-715
        • Research Site
      • Daejeon, Korea, Republic of, 35365
        • Research Site
      • Gwangju, Korea, Republic of, 61469
        • Research Site
      • Seongnam-si, Korea, Republic of, 13620
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 05505
        • Research Site
      • Seoul, Korea, Republic of, 03181
        • Research Site
      • Seoul, Korea, Republic of, 03312
        • Research Site
      • Seoul, Korea, Republic of, 08308
        • Research Site
      • Seoul, Korea, Republic of, 04763
        • Research Site
      • Suwon-si, Korea, Republic of, 16499
        • Research Site
      • Uijeongbu-si, Korea, Republic of, 11765
        • Research Site
      • Wonju, Korea, Republic of, 26426
        • Research Site
  • Philippines
      • Iloilo City, Philippines, 5000
        • Research Site
      • Manila, Philippines, 1000
        • Research Site
  • Taiwan
      • Taipei, Taiwan, 100
        • Research Site
      • Taipei, Taiwan, 112
        • Research Site
      • Taipei, Taiwan, 114
        • Research Site
      • Taoyuan City, Taiwan, 333
        • 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

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Written informed consent, and assent when applicable for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable local guidelines.
  2. Female and male aged 12 to 75 years, inclusively, at the time of Visit 1. For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
  3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250μg fluticasone propionate dry powder formulation equivalents total daily dose) and a LABA, for at least 6 months prior to Visit 1.
  4. Additional maintenance asthma controller medications that are locally approved in a country for the treatment of asthma (e.g., leukotriene receptor antagonists (LTRAs), tiotropium, chromone, theophylline, oral corticosteroid), and have been used for at least 30 days prior to Visit 1 are allowed.
  5. At least 2 documented asthma exacerbations in the 12 months prior to the date informed consent, and assent when available, during the treatment of medium-to-high dose ICS-LABA that required use of a systemic corticosteroid or a temporary increase from the patient's usual maintenance dose of oral corticosteroid. For patients who are re-screened within 30 days of their screen failure date, the calculation of the 12 month period should be done from the original informed consent, and assent when applicable date.
  6. Documented post-bronchodilator (post-BD) reversibility in FEV1 of >12% and >200 mL in FEV1 within 12 months prior to Visit 1. If historical documentation is not available, reversibility must be demonstrated and documented at Visit 2.

  7. Fulfilment of at least 1 of the following conditions over the 7 days prior to randomization:

    • >2 days with a daytime or night time symptoms score >1
    • Rescue Short-acting β2 agonist (SABA) use on >2 days
    • ≥1 nocturnal awakening due to asthma
  8. Pre-bronchodilator (Pre-BD) FEV1 of <80% predicted (<90% predicted for patients aged 12 to 17 years) at Visit 2.
  9. ACQ-6 score > = 1.5 at Visit 2.

Exclusion Criteria:

  1. Known history of clinically important pulmonary disease other than asthma (e.g., active lung infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g,. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).

  2. Known history of any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:

    • Affect the safety of the patient throughout the study
    • Influence the findings of the studies or their interpretations
    • Impede the patient's ability to complete the entire duration of study.
  3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent, and assent when applicable, is obtained or during the screening period.
  4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study.
  5. Current smokers or former smokers with a smoking history of > 10 pack-years.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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.
Placebo Comparator: Placebo
Placebo administered subcutaneously
Biological: Placebo
Placebo subcutaneously on study week 0 until study week 40 inclusive.
Experimental: Benralizumab
Benralizumab administered subcutaneously
Biological: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 40 inclusive.

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
Annual Asthma Exacerbation Rate in Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma for Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
Annual asthma exacerbation rate over the 48-week treatment period among benralizumab and placebo groups
From randomization through Study Week 48

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
Change From Baseline at Week 48 in Pre-bronchodilator FEV1 (L) Value for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
Change from baseline at Week 48 in Pre-bronchodilator FEV1 (L)
From randomization through Study Week 48
Change From Baseline at Week 48 in Total Asthma Symptom Score for for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
Daytime and nighttime symptoms are reported using a response scale ranging from 0 to 3 where 0 indicates no asthma symptoms. The total asthma symptom score is the sum of the daytime and nighttime scores and ranges from 0 to 6; a decrease in score indicates symptom improvement.
From randomization through Study Week 48
Change From Baseline at Week 48 in Total Asthma Rescue Medication Use for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
Change from baseline at week 48 in total rescue medication use (number of puffs/day)
From randomization through Study Week 48
Change From Baseline at Week 48 in Morning Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
Change from baseline at week 48 in morning PEF
From randomization through Study Week 48
Change From Baseline at Week 48 in Evening Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
Change from baseline at week 48 in evening PEF
From randomization through Study Week 48
Change From Baseline at Week 48 in the Proportion of Night Awakening Due to Asthma and Requiring Rescue Medication for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
Change from baseline at Week 48 in proportion of night awakening due to asthma and requiring rescue medication
From randomization through Study Week 48
Change From Baseline at Week 48 in Asthma Control Questionnaire 6 (ACQ-6) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses.
From randomization through Study Week 48
Time to First Asthma Exacerbation for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
Time to first asthma exacerbation over 48-week treatment period
From randomization through Study Week 48
Number and Percentage of Patients With >=1 Asthma Exacerbations Among Patients Who Were on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
Number and percentage of patients with at least one exacerbation over 48-week treatment period
From randomization through Study Week 48
Change From Baseline at Week 48 in Total Score of St. George's Respiratory Questionnaire (SGRQ) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
The SGRQ is a 50-item PRO instrument developed to measure the HRQoL of patients with airway diseases. The questionnaire is divided into two parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The total score indicates the impact of disease on overall HRQoL. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible HRQoL and 0 indicates the best possible HRQoL.
From randomization through Study Week 48
Annual Asthma Exacerbation Rate Associated With an Emergency Room/Urgent Care Visit or a Hospitalization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
Annual asthma exacerbation rate associated with an emergency room/urgent care visit or a hospitalization over 48-week treatment period
From randomization through Study Week 48
Number and Percentages of Asthma Specific Health Care Resource Utilization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
Asthma specific health care resource utilization over 48-week treatment period.
From randomization through Study Week 48
The Pharmacokinetics (PK) of Benralizumab as Assessed by Trough Concentration
Time Frame: week 0, week 24, week 48
PK trough concentrations at each visit
week 0, week 24, week 48
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs)
Time Frame: Pre-treatment until end of 48-week end of treatment
Anti-drug antibodies (ADA) responses at baseline and post baseline.
Pre-treatment until end of 48-week end of treatment
Percent Change From Baseline at Week 48 in Blood Eosinophil Levels for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time Frame: From randomization through Study Week 48
Percent change from baseline at Week 48 in blood eosinophil levels
From randomization through Study Week 48

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
Annual Asthma Exacerbation Rate in Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils <300/uL
Time Frame: From randomization through Study Week 48.
Annual asthma exacerbation rate over the 48-week treatment period among benralizumab and placebo groups
From randomization through Study Week 48.
Change From Baseline at Week 48 in Pre-bronchodilator FEV1 (L) Value for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils <300/uL
Time Frame: From randomization through Study Week 48
Change from baseline at Week 48 in Pre-bronchodilator FEV1 (L)
From randomization through Study Week 48
Change From Baseline at Week 48 in Total Asthma Symptom Score for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils <300/uL
Time Frame: From randomization through Study Week 48
Daytime and nighttime symptoms are reported using a response scale ranging from 0 to 3 where 0 indicates no asthma symptoms. The total asthma symptom score is the sum of the daytime and nighttime scores and ranges from 0 to 6; a decrease in score indicates symptom improvement.
From randomization through Study Week 48

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.

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.
September 7, 2017

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.
January 30, 2023

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.
January 30, 2023

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 19, 2017

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 12, 2017

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 14, 2017

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.
April 24, 2024

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.
March 28, 2024

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.
March 1, 2024

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.
  • D3250C00036
  • 2017-000702-38 (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 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
  • CSR

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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