NCT00873860已完成2 期
A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Parallel-Arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults With Uncontrolled, Moderate-to-severe, Persistent Asthma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 57
- 主要终点
- Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92
研究概览
简要总结
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled, moderate-to-severe, persistent asthma.
详细描述
Study MI-CP199, a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm, multicenter study will evaluate the effect of 3 SC treatment regimens of CAT-354 on asthma control in adults with uncontrolled, moderate-to-severe, persistent 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects
- •Age 18 to 65 years at the time of Screening
- •Subjects must have a body mass index (BMI) between 18 and 40 kilogram per square meter (kg/m^2)
- •Written informed consent obtained from the subject prior to performing any protocol related procedures, including Screening evaluations
- •Physician-diagnosed moderate-to-severe, persistent asthma requiring treatment with appropriate asthma controller medication
- •Shows forced expiratory volume in 1 second (FEV1) reversibility postbronchodilator of greater than or equal to (>=)12 percent and >=200 milliliter (mL) or have shown such values in a previous test within the last year, or have a positive airway hyperresponsiveness (AHR) test result in the last year
- •Pre-bronchodilator FEV 1 value >=40 percent of individual predicted value at Visits 1 and 3
- •Uncontrolled asthma consistent with Expert Panel Report (EPR)-
- •In the 2 to 4 weeks preceding Screening, subjects should have a history of 1 or more of the following: Daytime asthma symptoms >=2 days/week, Nighttime awakening >=1 night/week, Salbutamol use >=2 days/week
- •An Asthma control questionnaire (ACQ) score >=1.5 at Visits 1 and 3
- •At least 1 occurrence of asthma exacerbation in the past year that required an unscheduled medical encounter
- •Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide) and must use such precautions from Day 1 through Study Day 169
- •Otherwise healthy by medical history and physical examination for that age group
- •A chest x-ray or computed tomography (CT) scan within the previous 12 months with no findings suggestive of acute or chronic respiratory pathology other than asthma
- •Ability and willingness to complete the follow-up period until Day 169 as required by the protocol.
排除标准
- •Known history of allergy or reaction to any component of the investigational product formulation
- •Acute illness other than asthma at the start of the study
- •History of an active infection within 4 weeks prior to Screening, or evidence of clinically significant active infection, including ongoing chronic infection
- •History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or a diagnosis of parasitic infection within 6 months prior to Screening
- •Use of immunosuppressive medication (except oral prednisone up to 10 milligram/day (mg/day) and inhaled and topical corticosteroids) within 30 days before randomization into the study
- •Receipt of immunoglobulin or blood products within 30 days before randomization into the study
- •Receipt of any investigational drug therapy or use of any biologicals including omalizumab within 6 months before the first dose of investigational product in this study or within 5 half-lives of an investigational agent or biologic, whichever is longer
- •History of any known immunodeficiency disorder
- •A positive hepatitis B surface antigen, or hepatitis C virus antibody
- •A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report
- •A live or attenuated vaccination received within 4 weeks prior to Screening
- •Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study
- •History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator
- •Lactation (women)
- •History of treatment for alcohol or drug abuse within the past year
- •History suggestive of chronic obstructive pulmonary disease (COPD) and of cigarette smoking >=10 pack-years
- •Evidence of any systemic disease on physical examination
- •History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy less than or equal to (<=)1 year prior to Study Day 1 or other malignancies treated with apparent success with curative therapy <=5 years prior to entry
- •Known exposure to inhaled occupational agents or fumes
- •Any condition (eg, cystic fibrosis [CF] or COPD) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results
- •Individuals who are legally institutionalized
- •Employees of the clinical study site or any other individuals involved with the conduct of the study, or family members of such individuals.
结局指标
主要结局
Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92
时间窗: Day 1 and 92
Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.
次要结局
- Time to First Observed Asthma Control(Day 1 to Day 92 and Day 169)
- Number of Puffs of Rescue Beta-2 Agonist Per Week(Day -7 to 169)
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169(Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169)
- Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169(Day -7 to 1 (predose), Day 2 to 169)
- Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores(Day 1, 29, 57, 92, 127 and 169)
- Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169(Day 1, 29, 57, 92, 127 and 169)
- Patient Global Impression of Change (PGIC)(Day 92 and 169)
- Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5(Day 92 and 169)
- Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit(Day 1, 92 and 169)
- Serum Concentration for CAT-354(Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169)
- Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit(Day 1, 92 and 169)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)(Day 1 to 169)
- Percentage of Participants With at Least 1 Moderate or Severe Exacerbation(Day 92 and 169)
- Moderate or Severe Asthma Exacerbations Per Person Per Annum(Day 1 to Day 92 and Day 169)
- Time to First Moderate or Severe Asthma Exacerbation(Day 1 to Day 92 and Day 169)
研究者
研究点 (57)
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