NCT07302516尚未招募3 期
A Multi-center, Randomised, Double Blind, Active Controlled Phase III Trial to Compare the Efficacy and Safety of QL2302 With Tezspire® in Adults With Uncontrolled Severe Asthma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 636
- 主要终点
- Primary endpoint ：
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy and safety of QL2302 and Tezspire® in patients with uncontrolled severe asthma. The main questions it aims to answer are:
- if the efficacy of QL2302 and Tezspire® are similar
- if the safety of QL2302 and Tezspire® are similar
Participants will be randomised to QL2302 or Tezspire® group and asked to receive one injection of QL2302 or Tezspire® subcutaneously every four weeks till Week 48, which means participants will receive a total of 13 injections. And be observed for another 12 weeks after the end of treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 year of age
- •Body weight ≥40 kg
- •Diagnosed with asthma ≥12 months
- •Received a total daily dose of medium/high dose of ICS for more than 3 months steadily
- •At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
- •Morning pre-BD FEV1 <80% but ≥35% predicted normal
- •Evidence of asthma as documented by reversibility test or change of PEF.
- •Documented history of at least 1 asthma exacerbation events within 12 months.
- •ACQ-5 score ≥1.5 at screening and on day of randomization
排除标准
- •Pulmonary disease other than asthma.
- •History of cancer within 5 years except those cured.
- •History of a clinically significant infection within 4 weeks.
- •Current smokers or participants with smoking history ≥10 pack-yrs.
- •History of chronic alcohol or drug abuse within 12 months.
- •Positive Hepatitis B, C or HIV infection.
- •Pregnant or breastfeeding.
- •History of anaphylaxis following any biologic therapy.
- •Participant received tezepelumab or other TSLP antibody priorly.
- •Participant received bronchial thermoplasty within 12 months.
研究组 & 干预措施
QL2302
Experimental
干预措施: tezepelumab (Arm1&Arm2) (Biological)
Tezspire®
Active Comparator
干预措施: tezepelumab (Arm1&Arm2) (Biological)
结局指标
主要结局
Primary endpoint ：
时间窗: 52 weeks
Annualized Asthma Exacerbation Rate (AAER)
次要结局
未报告次要终点
研究者
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