NCT01582503已完成2 期
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of MEMP1972A in Adults With Allergic Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA)
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
- 578
- 主要终点
- Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a second controller medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with a 48-week follow-up.
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 inclusive
- •Body weight >/= 40 kg
- •Physician's diagnosis of asthma for at least 12 months
- •Evidence of documented bronchodilator reversibility as defined by protocol
- •Prebronchodilator FEV1 >/= 40% and </= 80% predicted at Visit 1
- •Required daily use of ICS and a second controller for a minimum of 3 consecutive months prior to Visit 1
- •History of at least one protocol-defined asthma exacerbation in the 18 months prior to Visit 1
- •Inadequately controlled asthma despite compliance with asthma controller therapy
排除标准
- •Asthma exacerbation requiring systemic steroids in the 30 days prior to Visit 1
- •Pre-existing active lung disease other than asthma
- •Any infection
- •Clinically significant medical disease that is uncontrolled despite treatment or is likely to require a change in therapy during study or is of unknown etiology
- •Known immunodeficiency, including but not limited to HIV infection, regardless of treatment status
- •Current substance abuse
- •Former smoker with >10 pack-year history or current smoker; former smokers must have stopped smoking more than 12 months prior to Visit 1
- •History of anaphylaxis
- •Pregnant and lactating women
研究组 & 干预措施
MEMP1972A 450 mg
Experimental
干预措施: MEMP1972A (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
MEMP1972A 300 mg
Experimental
干预措施: MEMP1972A (Drug)
MEMP1972A 150 mg
Experimental
干预措施: MEMP1972A (Drug)
结局指标
主要结局
Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36
时间窗: 36 weeks
次要结局
- Relative change in pre-bronchodilator FEV1 (volume)(from baseline to Week 12)
- Relative change in FEV1 (volume)(from baseline to Week 36)
- Change in asthma symptoms(from baseline to Week 36)
- Proportion of "well-controlled" weeks (no nighttime awakenings due to asthma symptoms and </= 2 days of SABA use per weeks, as documented by patient diary) from Week 24 to Week 36(12 weeks)
- Safety: Incidence of adverse events(48 weeks)
- Incidence of anti-therapeutic antibodies (ATAs)(84 weeks)
- Pharmacokinetics: Area under the concentration-time curve (AUC)(Pre- and post-dose Weeks 0, 4, 12, 24 and 36)
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