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A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)

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ClinicalTrials.gov Identifier: NCT02808819
Recruitment Status : Completed
First Posted : June 22, 2016
Results First Posted : April 13, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).

Condition or disease Intervention/treatment Phase
Asthma Biological: Benralizumab Phase 3

Detailed Description:
This is an open-label safety extension study designed to evaluate the safety and tolerability of a fixed 30 mg dose of benralizumab administered subcutaneously (SC) in severe asthma patients on inhaled corticosteroid and long-acting β2 agonist (ICS-LABA) therapy with or without chronic oral corticosteroids (OCS) and/or other asthma controllers. All patients will receive active drug on the same dosing regimen they received in BORA (NCT02258542). In order to protect the blind of BORA, patients will remain blinded to treatment regimen allocation until they have completed all end of treatment (EOT) assessments in BORA and signed informed consent for participation in this study, after which treatment allocation will be unblinded to both the investigator and the patient.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 447 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)
Actual Study Start Date : June 30, 2016
Actual Primary Completion Date : June 18, 2020
Actual Study Completion Date : June 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Benralizumab Arm A
Benralizumab administered subcutaneously every 4 weeks
Biological: Benralizumab
Benralizumab administered subcutaneously every 4 weeks

Benralizumab Arm B
Benralizumab administered subcutaneously every 8 weeks
Biological: Benralizumab
Benralizumab administered subcutaneously every 8 weeks




Primary Outcome Measures :
  1. Change From Baseline in Basophils, Full Analysis Set [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from baseline in hematologic lab parameter of Basophils.

  2. Change From Baseline in Leukocytes, Full Analysis Set [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from baseline in hematologic lab parameter of Leukocytes.

  3. Change From Baseline in Lymphocytes, Full Analysis Set [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from baseline in hematologic lab parameter of Lymphocytes.

  4. Change From Baseline in Neutrophils, Full Analysis Set [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from baseline in hematologic lab parameter of Neutrophils.

  5. Change From Baseline in Monocytes, Full Analysis Set [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from baseline in hematologic lab parameter of Monocytes.

  6. Change From Baseline in Platelets, Full Analysis Set [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from baseline in hematologic lab parameter of Platelets.

  7. Change From Baseline in Hematocrit, Full Analysis Set [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from baseline in hematologic lab parameter of Hematocrit.

  8. Change From Baseline in Erythrocytes, Full Analysis Set [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from baseline in hematologic lab parameter of Erythrocytes.

  9. Change From Baseline in Hemoglobin, Full Analysis Set [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from baseline in hematologic lab parameter of Hemoglobin.

  10. Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from baseline in chemistry test ALT.

  11. Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from baseline in chemistry test AST.

  12. Change From Baseline in Bilirubin, Full Analysis Set [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from baseline in chemistry test Bilirubin.


Secondary Outcome Measures :
  1. Number of Participants With Asthma Exacerbations During Study Period [ Time Frame: From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with asthma exacerbation during this period is presented. ]
    Asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit

  2. Number of Participants Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period [ Time Frame: From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with health care encounters during this period is presented. ]
    Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma

  3. Change of Blood Eosinophils Count [ Time Frame: From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented. ]
    Change from Baseline to End of Treatment in blood eosinophils count.

  4. Number of Participants With Anti-drug Antibodies (ADA) Responses During the Study [ Time Frame: From week 0 to week 184 in study treatment period and plus 12 weeks follow up period ]
    Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study

  5. Duration of Exposure [ Time Frame: From week 0 to week 184 in study treatment period ]
    Duration of exposure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines.
  • Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021.
  • Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of Investigational Product (IP)
  • For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1.
  • All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.

Exclusion Criteria:

  • Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, 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 study or their interpretations
    • Impede the patient's ability to complete the entire duration of study
  • A helminth parasitic infection diagnosed during a predecessor study that has either required hospitalization, has not been treated, has been incompletely treated or has failed to respond to standard of care therapy
  • Any clinically significant change in physical examination, vital signs, ECG, hematology, clinical chemistry, or urinalysis during the predecessor study 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 interfere with the patient's ability to complete the entire duration of the study
  • Current malignancy or malignancy that developed during the predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded).
  • Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the IP
  • Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
  • Planned major surgical procedures during the conduct of the study
  • Previous participation in the present study
  • Concurrent enrolment in another drug-related interventional clinical trial
  • AstraZeneca staff involved in the planning and/or conduct of the study
  • Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals
  • Patients with important protocol deviations in the predecessor study at the discretion of the Sponsor
  • Patients with ongoing serious adverse events (SAEs) from the prior study should not be enrolled into the this extension study until the SAE has resolved

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808819


Locations
Show Show 178 study locations
Sponsors and Collaborators
AstraZeneca
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] October 14, 2019
Statistical Analysis Plan  [PDF] July 16, 2020

Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02808819    
Other Study ID Numbers: D3250C00037
First Posted: June 22, 2016    Key Record Dates
Results First Posted: April 13, 2021
Last Update Posted: April 13, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
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.
Supporting Materials: Study Protocol
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
Keywords provided by AstraZeneca:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases
Obstructive Lung Diseases
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Benralizumab
Anti-Asthmatic Agents
Respiratory System Agents