A Randomized, Double-blind, Placebo- and Comparator-controlled Study Evaluating the Effect of Multiple Doses of QGE031 Compared to Omalizumab in Asthma Induced by Allergen Bronchial Provocation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1)
研究概览
简要总结
This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline will be evaluated.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18 to 65 years
- •Positive skin prick test to one or more common airborne allergens
- •Presence of airway hyperresponsiveness documented by a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20 FEV1) of less than or equal to 16 mg/mL
- •Presence of an early asthmatic response demonstrated by an allergen challenge at screening and including a 15% fall in the FEV1
- •Patients with a body weight and total IgE in a range specified by local country prescribing information for omalizumab
排除标准
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential unless they are using a highly effective method of birth control (as further defined in the study protocol)
- •Patients with poorly controlled asthma or patients who have had an asthma exacerbation within the past year
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
QGE031
During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses). Three dose levels of QGE031 will be offered during the study: low, medium, and high. Participants will be randomized to receive one of these dose levels for all dosing visits.
干预措施: QGE031 (Drug)
omalizumab
During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses) or once every four weeks (total of three doses). The dose that a participant receives will depend upon the participant's body weight and IgE level; dosage will be determined based upon local omalizumab dosing charts.
干预措施: omalizumab (Drug)
placebo
During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses).
干预措施: placebo (Drug)
结局指标
主要结局
Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1)
时间窗: Baseline, 12 weeks
次要结局
- QGE031 blood concentrations(24 weeks)
- Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1) following treatment with placebo and various doses of QGE031(Baseline, 12 weeks)
- Number of participants with adverse events or other safety concerns(24 weeks)