A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2,538
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model
研究概览
简要总结
This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma.
The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients:
- Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and
- New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039.
By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.
详细描述
The study comprised 2-treatment period. Treatment Period 1 was a 52-week, double-blind treatment period in which QAW039 450 mg or 150 mg or placebo was added to standard-of-care asthma therapy according to GINA guidelines. Treatment Period 2 was an optional 104-week, single-blind treatment period in which patients received QAW039 450 mg or 150 mg or placebo added to standard-of-care asthma therapy according to GINA guidelines.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients completing a prior Phase 3 study of QAW039:
- •Informed consent and assent (if applicable).
- •Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW
- •Patient is able to safely continue into the study as judged by the investigator.
- •Patients who have not previously participated in a study of QAW039:
- •Written informed consent.
- •A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication.
- •Evidence of airway reversibility or airway hyper- reactivity.
- •FEV1 of ≤85% of the predicted normal value.
- •An ACQ score ≥1.5 prior to entering the study.
排除标准
- •Patients completing a prior phase 3 study of QAW039:
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug
- •Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.
- •Inability to comply with all study requirements.
- •Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in.
- •Patients who have not previously participated in a study of QAW039:
- •Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
- •Subjects who have participated in another trial of QAW039 (i.e.-the patient was randomized in another study).
- •A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
- •History of malignancy with the exception of local basal cell carcinoma of the skin
- •Pregnant or nursing (lactating) women.
- •Serious co-morbidities.
- •Patients on greater than 20 mg of simvastatin> 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.
研究组 & 干预措施
QAW039 150mg
QAW039 Dose 1 once daily
干预措施: QAW039 150 mg (Drug)
QAW039 450 mg
QAW039 Dose 2 once daily
干预措施: QAW039 450 mg (Drug)
Placebo
Placebo once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model
时间窗: 52 weeks
Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs. For this Outcome Measure, AE up to week 52 are reported.
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model
时间窗: 156 weeks
Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs.
Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model
时间窗: 52 weeks
Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation. For this Outcome Measure, AE up to week 52 are reported.
Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model
时间窗: 156 weeks
Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation
Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model
时间窗: 52 weeks
Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs. For this Outcome Measure, AE up to week 52 are reported.
Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model
时间窗: 156 weeks
Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs
次要结局
- Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model(52 weeks)
- Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model(156 weeks)
- Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52(52 weeks)
- Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156(156 weeks)
- Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52(52 weeks)
- Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156(156 weeks)