NCT01238861已完成2 期
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 964
- 试验地点
- 78
- 主要终点
- Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants
研究概览
简要总结
The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.
详细描述
This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of multiple-dose (7 doses) subcutaneous administration of benralizumab (MEDI-563) in adult subjects with uncontrolled asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 through 75 years at the time of screening
- •Adequate contraception from screening through end of trial
- •Weight of more than (>) 45 kilogram (kg) but less than or equal to (<=) 150 kg (>100 pound [lb] but <=330 lb)
- •History of physician-diagnosed asthma for at least 12 months prior to screening
- •Physician prescribed daily use of medium-dose or high-dose inhaled corticosteroid(s) (ICS) plus long-acting beta 2 agonist (LABA) for at least 12 months prior to screening
- •Willingness to switch to an ICS/LABA combination product
- •Dose of other asthma controller medications must be stable for at least 30 days prior to screening
- •At least 2 documented asthma exacerbations in the 12 months prior to screening that required use of a systemic corticosteroid burst
- •For subjects 65 years of age or older, a chest x-ray (CXR) or chest computed tomography (CT) that is normal for an asthmatic population
- •Ability and willingness to complete the study to Week 66, and if needed to Week 92.
排除标准
- •Known history of allergy or reaction to any component of the investigational product formulation
- •History of anaphylaxis to any biologic therapy
- •Unexplained diarrhea within 30 days prior to screening or diagnosis of helminth parasitic infestation within 6 months prior to screening
- •Use of immunosuppressive medication within 3 months prior to screening. Chronic oral prednisone or equivalent up to 10 milligram (mg) daily or 20 mg every other day for asthma is allowed
- •Oral corticosteroid burst or short-acting systemic corticosteroid within 30 days prior to screening or during the screening/run-in period
- •Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to the screening or during the screening/run-in period
- •Receipt of immunoglobulin or blood products within 30 days prior to screening
- •Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to screening, whichever is longer
- •Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to screening, whichever is longer
- •Previously received MEDI-563
- •Any clinically relevant abnormal findings in physical examination
- •Past history of clinically significant cardiac disease or any electrocardiogram (ECG) abnormality
- •Breastfeeding or lactating women
- •History of alcohol or drug abuse within 12 months prior to screening
- •History of any known primary immunodeficiency disorder
- •Positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol
- •A positive human immunodeficiency virus (HIV) test or subject taking antiretroviral medications
- •History of cigarette smoking more than or equal to (>=) 10 pack-years or smoking within 12 months prior to screening.
- •Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma
- •History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy >=12 months prior to screening or other malignancies treated with apparent success with curative therapy >=5 years prior to screening
- •Stable dose of allergy vaccination regimen for less than 30 days prior to screening
- •Subjects unable to demonstrate acceptable inhaler and peak flow meter techniques.
结局指标
主要结局
Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants
时间窗: Week 1 up to Week 52
The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1.
次要结局
- Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss)(Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52)
- Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants(Baseline up to Week 92)
- Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52(Baseline up to Week 52)
- Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD)(Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52)
- Dose Response in EOS+ Participants(Baseline up to Week 66)
- Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52(Baseline up to Week 52)
- Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52(Baseline up to Week 51-52)
- Change From Baseline in Rescue Medication Use at Week 51-52(Baseline up to Week 51-52)
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52(Baseline and Week 52)
- Change From Baseline in Peak Expiratory Flow (PEF) at Week 52(Baseline and Week 52)
- Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52(Baseline and Week 52)
- Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52(Baseline and Week 52)
- Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52(Baseline and Week 52)
- Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52(Baseline up to Week 51-52)
- Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52(Baseline and Week 52)
- Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52(Baseline up to Week 52)
研究者
研究点 (78)
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