Overview

This trial is active, not recruiting.

Condition asthma
Treatments benralizumab
Phase phase 3
Sponsor AstraZeneca
Start date November 2014
End date October 2017
Trial size 2200 participants
Trial identifier NCT02258542, D3250C00021, U1111-1162-2422

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Arm
(Experimental)
Benralizumab administered subcutaneously
benralizumab
Benralizumab administered subcutaneously
(Experimental)
Benralizumab administered subcutaneously
benralizumab
Benralizumab administered subcutaneously

Primary Outcomes

Measure
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 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)

Secondary Outcomes

Measure
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)
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)
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) 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)
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)
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)
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 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)
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
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
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)
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)
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)
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)

Eligibility Criteria

Male or female participants from 12 years up to 75 years old.

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

Additional Information

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)
Principal investigator William W. Busse, M.D., Professor of Medicine
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.