NCT01545440已完成2 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 258
- 主要终点
- Rate of asthma exacerbations during the 52-week placebo-controlled period
研究概览
简要总结
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.
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
- •Adult patients, 18 to 75 years of age at Visit 1
- •Asthma diagnosis for >/= 12 months prior to the start of screening (Visit 1)
- •Bronchodilator response during screening
- •Pre-bronchodilator FEV1 40%-80% of predicted during screening
- •On ICS (inhaled corticosteroids) 500-2000 mcg/day of fluticasone propionate DPI or equivalent for >/= 6 months prior to the start of screening (Visit 1) with no anticipated changes throughout the study
- •On an eligible second controller medication (LABA, LAMA, LTRA or theophylline within the prescribed dosing range)
- •Uncontrolled asthma as defined by protocol both during screening period and at time of randomization
- •Chest X-ray or computed tomography (CT) scan obtained within 12 months prior to screening or chest X-ray during screening period confirming the absence of other lung disease
- •Demonstrated adherence with controller medication during the screening period
排除标准
- •History of severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- •Use of zileuton or roflumilast within 6 months prior to screening
- •Maintenance oral corticosteroid therapy, defined as daily or alternate day oral corticosteroid maintenance therapy within the 3 months prior to Visit 1
- •Treatment with systemic (oral, intravenous or intramuscular) corticosteroids within the 4 weeks prior to Visit 1
- •Major episode of infection within 4 weeks prior to Visit 1 or treatment with oral antibiotics within 2 weeks prior to Visit 1
- •Active parasitic infection within the 6 months prior to Visit 1
- •Active tuberculosis requiring treatment within the 12 months prior to Visit 1
- •Known immunodeficiency, including, but not limited to, HIV infection
- •Evidence of acute or chronic hepatitis or known liver cirrhosis
- •History of cystic fibrosis, chronic obstructive pulmonary disease, and/or other clinically significant lung disease other than asthma
- •Known malignancy or current evaluation for a potential malignancy
- •Current smoker or former smoker with a history >10 pack years
- •History of alcohol, drug or chemical abuse
- •Initiation or change in allergen immunotherapy within 3 months prior to Visit 1
- •Use of biologic therapy including omalizumab during 6 months prior to Visit 1
- •Receipt of live/attenuated vaccine within 4 weeks prior to Visit 1
- •Pregnant or lactating women
- •Body mass index (BMI) > 38 kg/m2
- •Body weight < 40 kg
研究组 & 干预措施
lebrikizumab - highest dose
Experimental
干预措施: lebrikizumab (Drug)
lebrikizumab - lowest dose
Experimental
干预措施: lebrikizumab (Drug)
lebrikizumab - middle dose
Experimental
干预措施: lebrikizumab (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Rate of asthma exacerbations during the 52-week placebo-controlled period
时间窗: weeks 0-52
次要结局
- Time to first asthma exacerbation(from baseline to week 52)
- Change in fractional exhaled nitric oxide (FeNO)(from baseline to week 52)
- Change in asthma rescue medication use(from baseline to week 52)
- Change in lung function: pre-bronchodilator FEV1(from baseline to week 52)
- Change in asthma-specific health-related quality of life, assessed by the Standardized Asthma Quality of Life Questionnaire (AQLQ[S])(from baseline to week 52)
- Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period(from baseline to week 52)
研究者
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