A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 447
- 试验地点
- 178
- 主要终点
- Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 D3250C
- •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
- •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.
排除标准
- •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
研究组 & 干预措施
Benralizumab Arm B
Benralizumab administered subcutaneously every 8 weeks
干预措施: Benralizumab (Biological)
Benralizumab Arm A
Benralizumab administered subcutaneously every 4 weeks
干预措施: Benralizumab (Biological)
结局指标
主要结局
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set
时间窗: 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.
Change From Baseline in Hematocrit, Full Analysis Set
时间窗: 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.
Change From Baseline in Basophils, Full Analysis Set
时间窗: 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.
Change From Baseline in Erythrocytes, Full Analysis Set
时间窗: 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.
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set
时间窗: 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.
Change From Baseline in Neutrophils, Full Analysis Set
时间窗: 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.
Change From Baseline in Monocytes, Full Analysis Set
时间窗: 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.
Change From Baseline in Hemoglobin, Full Analysis Set
时间窗: 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.
Change From Baseline in Bilirubin, Full Analysis Set
时间窗: 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.
Change From Baseline in Leukocytes, Full Analysis Set
时间窗: 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.
Change From Baseline in Lymphocytes, Full Analysis Set
时间窗: 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.
Change From Baseline in Platelets, Full Analysis Set
时间窗: 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.
次要结局
- Number of Participants With Anti-drug Antibodies (ADA) Responses During the Study(From week 0 to week 184 in study treatment period and plus 12 weeks follow up period)
- Number of Participants With Asthma Exacerbations During Study Period(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.)
- Duration of Exposure(From week 0 to week 184 in study treatment period)
- 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(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.)
- Change of Blood Eosinophils Count(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.)