A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 1
- 主要终点
- Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks
研究概览
简要总结
This study will assess the efficacy and safety of GSK3511294 (Depemokimab) as an adjunctive therapy in participants with severe uncontrolled asthma with an eosinophilic phenotype.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GSK3511294
Participants received a 100 milligram (mg) dose of GSK3511294 subcutaneous (SC) injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma standard of care (SOC) treatment throughout the study.
干预措施: GSK3511294 (Biological)
Placebo
Participants received placebo SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance asthma SOC treatment throughout the study.
干预措施: Placebo (Biological)
结局指标
主要结局
Annualized Rate of Clinically Significant Exacerbations up to 52 Weeks
时间窗: Up to Week 52
Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) \[such as intramuscular (IM), intravenous (IV) or oral\] and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the electronic case report form (eCRF) were considered as verified clinically significant exacerbations and included in the primary analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.
次要结局
- Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52(Baseline (Day 1) and Week 52)
- Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52(Baseline (Day 1) and Week 52)
- Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52(Baseline (Day 1) and Week 52)
- Change From Baseline in Asthma Nighttime Symptom Diary (ANSD) Weekly Mean Score at Week 52(Baseline to Week 52)
- Change From Baseline in Asthma Daily Symptom Diary (ADSD) Weekly Mean Score at Week 52(Baseline to Week 52)
- Annualized Rate of Exacerbations Requiring Hospitalization and/or Emergency Department (ED) Visit up to 52 Weeks(Up to Week 52)