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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 : Active, not recruiting
First Posted : June 22, 2016
Last Update Posted : August 14, 2019
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).

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. 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
Estimated Primary Completion Date : June 29, 2020
Estimated Study Completion Date : June 29, 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. 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

  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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) ]
  5. 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) ]


Information from the National Library of Medicine

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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


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Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02808819     History of Changes
Other Study ID Numbers: D3250C00037
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by AstraZeneca:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases
Obstructive Lung Diseases
Additional relevant MeSH terms:
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Benralizumab
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents