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

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.
 
ClinicalTrials.gov Identifier: NCT02808819
Recruitment Status : Active, not recruiting
First Posted : June 22, 2016
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE June 7, 2016
First Posted Date  ICMJE June 22, 2016
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE June 30, 2016
Estimated Primary Completion Date June 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
  • Number of subjects with Adverse Events or Serious Adverse Events (AEs/SAEs) [ Time Frame: From week 0 to week 130 in the study treatment period and through the follow up period (12 weeks after last dose) ]
    Number of Adverse Events/ Serious Adverse Events
  • Shift from baseline to maximum post-baseline in standard chemistry lab parameters [ Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose) ]
  • Shift from baseline to minimum post-baseline in standard chemistry lab parameters [ Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose) ]
  • Shift from baseline to maximum post-baseline in standard hematology lab parameters [ Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose) ]
  • Shift from baseline to minimum post-baseline in standard hematology lab parameters [ Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02808819 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
  • Number of asthma exacerbations [ Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose) ]
    Annual asthma exacerbation rate
  • Number of exacerbations requiring hospitalization [ Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose) ]
    Annual exacerbations rate requiring hospitalization
  • Number of exacerbations requiring emergency room visit [ Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose) ]
    Annual exacerbations rate requiring emergency room visit
  • Absolute eosinophil counts [ Time Frame: Every 16 weeks for the first year and every 24 weeks after first year up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose) ]
  • Anti-drug antibodies (ADA) as a measure of immunogenicity [ Time Frame: Every 16 weeks for the first year and every 24 weeks after first year up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist
Official Title  ICMJE A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)
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).
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. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Asthma
Intervention  ICMJE
  • Biological: Benralizumab
    Benralizumab administered subcutaneously every 4 weeks
  • Biological: Benralizumab
    Benralizumab administered subcutaneously every 8 weeks
Study Arms  ICMJE
  • Benralizumab Arm A
    Benralizumab administered subcutaneously every 4 weeks
    Intervention: Biological: Benralizumab
  • Benralizumab Arm B
    Benralizumab administered subcutaneously every 8 weeks
    Intervention: Biological: Benralizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 13, 2019)
447
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2016)
770
Estimated Study Completion Date  ICMJE June 29, 2020
Estimated Primary Completion Date June 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Bulgaria,   Canada,   Chile,   Czechia,   France,   Germany,   Poland,   Russian Federation,   Spain,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Peru,   Philippines
 
Administrative Information
NCT Number  ICMJE NCT02808819
Other Study ID Numbers  ICMJE D3250C00037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP