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A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA (BORA)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02258542
First Posted: October 7, 2014
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.

Condition Intervention Phase
Asthma Biological: Benralizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of patients with Adverse Events/abnormal lab variables, Physical Examinations as measures of safety and tolerability of two dosing regimens of benralizumab for adult patients [ Time Frame: From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    - Number of Number of Adverse Events/Serious Adverse Events (AEs/SAEs); - Laboratory variables; - Physical Examination

  • Number of adolescent patients with Adverse Events/abnormal lab variables, Physical Examinations as measures of safety and tolerability of two dosing regimens of benralizumab for adolescent patients [ Time Frame: From week 0 to week 108-week in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    - Number of AEs/SAEs; - Laboratory variables; - Physical Examination


Secondary Outcome Measures:
  • Number of adult patients with asthma exacerbations during study treatment period [ Time Frame: From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    Annual asthma exacerbation rate, where an 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

  • Number of adolescent patients with asthma exacerbations during study treatment period [ Time Frame: From week 0 to week 108-week in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    Annual asthma exacerbation rate, where an 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

  • Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions (WPAI+CIQ) utilization as a measure of health care utilization and work & productivity loss in adult patients [ Time Frame: From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions (WPAI+CIQ); Hospitalizations, Emergency Department (ED) visits, urgent care visits and all other outpatient visits due to asthma

  • Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions (WPAI+CIQ) utilization as a measure of health care utilization and work & productivity loss in adolescent patients [ Time Frame: From week 0 to week 108-week in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    WPAI+CIQ; Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma

  • Asthma related and general health-related quality of life in adult patients [ Time Frame: From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12); European Quality of Life-5 Dimensions (EQ-5D-5L) questionnaire

  • Asthma related and general health-related quality of life in adolescent patients [ Time Frame: From week 0 to week 108-week in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    AQLQ(S)+12; EQ-5D-5L

  • Asthma Control Questionnaire as a measure of asthma control in adult patients [ Time Frame: From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    Asthma Control Questionnaire 6 (ACQ-6)

  • Asthma Control Questionnaire as a measure of asthma control in adolescent patients [ Time Frame: From week 0 to week 108-week in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    ACQ-6

  • Pre-dose benralizumab concentration in serum during the treatment phase of the safety study [ Time Frame: From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period ]
    Endpoint: Pharmacokinetic (PK) parameters

  • Anti-drug antibodies (ADA) as a measure of immunogenicity assessments [ Time Frame: From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period ]
    Neutralizing antibody responses (nAb responses) measurement as a positive or negative determination on the ADA-positive samples

  • Spirometry tests as a measure of pulmonary function in adult patients [ Time Frame: From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    Pre-bronchodilator Forced expiratory volume in 1 second (FEV1) and post-bronchodilator FEV1 at the study centre

  • Spirometry tests as a measure of pulmonary function in adolescent patients [ Time Frame: From week 0 to week 108-week in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    Pre-bronchodilator FEV1 and post-bronchodilator FEV1 at the study centre

  • Collection of blood samples for eosinophil levels' measurement in adult patients [ Time Frame: From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    Blood eosinophils

  • Collection of blood samples for eosinophil levels' measurement in adolescent patients [ Time Frame: From week 0 to week 108-week in study treatment period and through the follow up period (16 weeks from day of last dose) ]
    Blood eosinophils


Enrollment: 2133
Actual Study Start Date: November 19, 2014
Estimated Study Completion Date: July 9, 2018
Primary Completion Date: October 18, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Benralizumab Arm A
Benralizumab administered subcutaneously
Biological: Benralizumab
Benralizumab administered subcutaneously
Experimental: Benralizumab Arm B
Benralizumab administered subcutaneously
Biological: Benralizumab
Benralizumab administered subcutaneously

Detailed Description:

After a minimum of 1200 patients have been enrolled in this study, subsequent patients (up to a maximum of 2200 total for the study), who complete a minimum of 16 weeks, and no more than 40 weeks, in this study, will be given the option to transition to an open-label safety extension study, Study D3250C00037 (MELTEMI).

Adolescent patients, patients from Japan and South Korea, and any patient who chooses not to enter Study D3250C00037 will remain in this study through IPD or EOT and FU.

At the time of the first interim analysis in Japanese patients, the study regimen for all patients will become unblinded to AstraZeneca for data analysis purposes. Study conduct and blinding at the site and patient level will remain unchanged.

  Eligibility

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.


Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Informed consent (and/or assent as applicable locally) 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 European Union guidelines.
  2. Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo.
  3. Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after last dose of Investigational Product (IP).
  4. For WOCBP only: Have a negative urine pregnancy test prior to administration of Investigational Product (IP) at Visit 1.
  5. 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

  1. 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
  2. A helminth parasitic infection diagnosed during a predecessor study that has either not been treated, has been incompletely treated or has failed to respond to standard of care therapy
  3. Any clinically significant change in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a 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
  4. Current malignancy or malignancy that developed during a 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).
  5. 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 investigational product
  6. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
  7. Planned major surgical procedures during the conduct of the study
  8. Previous participation in the present study
  9. Concurrent enrolment in another clinical trial
  10. AstraZeneca staff involved in the planning and/or conduct of the study
  11. Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals
  12. Patients with major protocol deviations in any of the predecessor studies at the discretion of the Sponsor
  Contacts and Locations
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): NCT02258542


  Show 439 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: William W. Busse, M.D., Professor of Medicine Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02258542     History of Changes
Other Study ID Numbers: D3250C00021
U1111-1162-2422 ( Other Identifier: WHO )
First Submitted: September 1, 2014
First Posted: October 7, 2014
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by AstraZeneca:
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases