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
- 395
- 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 is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) 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 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: GSK3511294 (Depemokimab) (Biological)
Placebo
Participants received placebo 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: Placebo (Drug)
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)