A Multicenter,Randomized,Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Poorly Controlled Severe Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Annual Asthma Exacerbation Rate
研究概览
简要总结
This is a phase II, multicenter, double-blind, randomized, parallel group, placebo-controlled clinical study to evaluate the effect of three doses of TQC2731 on Annualized Asthma Exacerbation Rates(AAER) in adult subjects with poor control of severe asthma. It is estimated that 220 subjects will be included. The subjects will receive TQC2731 (70 mg Q4w, 210 mg Q4w, 420 mg Q4w) or placebo (Q4w) administered by Subcutaneous (SC) in the ratio of 1:1:1:1.
The study comprised a 5 to 6-week screening period, a 52-week treatment period and a 12-week follow-up period. During the treatment period, the study drug will be administered from day 0 until week 48. The study drug was not administered at the 52nd week.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 Age. 18-75
- •2 Documented physician-diagnosed asthma for at least 12 months before visit
- •3 Subjects who have received a physician-prescribed asthma controller medication with medium or high dose inhaled glucocorticosteroid (ICS) for at least 12 months before visit
- •4 Documented treatment with a total daily dose of either medium or high dose ICS for at least 3 months before visit
- •5 At least one additional maintenance asthma controller medication such as Long acting β2 receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, Long-acting muscarinic antagonists (LAMA), sodium cromoglycate, etc. is required according to standard practice of care and must be documented for at least 3 months.
- •6 Morning pre-BD FEV1 <80% predicted normal At visit 2 or visit 2a.
- •7 Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months before visit 1 OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening At visit 2 or visit 2a.
- •8 Documented history of at least 2 asthma exacerbation events within 12 months before visit
- •9 ACQ-6 score ≥1.5 at visit 1
- •10 Body weight ≥ 40 kg at visit 1.
排除标准
- •1 Pulmonary disease other than asthma.
- •2 History of cancer.
- •3 Current smokers or subjects with smoking history ≥10 pack-years.
- •4 Hepatitis B, C, human immunodeficiency virus (HIV) or Syphilis.
- •5 History of anaphylaxis following any biologic therapy.
- •6 History of chronic alcohol or drug abuse within 12 months.
- •7 History of a clinically significant infection.
- •8 Pregnant or breastfeeding.
研究组 & 干预措施
Placebo
Placebo, subcutaneous administration, 4 weeks as a treatment cycle.
干预措施: Placebo (Drug)
TQC2731 injection 70 mg
TQC2731 injection 70 mg, subcutaneous administration, 4 weeks as a treatment cycle.
干预措施: TQC2731 injection (Drug)
TQC2731 injection 210 mg
TQC2731 injection 210 mg, subcutaneous administration, 4 weeks as a treatment cycle.
干预措施: TQC2731 injection (Drug)
TQC2731 injection 420 mg
TQC2731 injection 420 mg, subcutaneous administration, 4 weeks as a treatment cycle.
干预措施: TQC2731 injection (Drug)
结局指标
主要结局
Annual Asthma Exacerbation Rate
时间窗: Baseline up to Study Week 64
The annual exacerbation rate is based on annualized asthma exacerbation rates reported by the investigator in the electronic case report form(eCRF). The analysis is based on the primary population (Full Analysis Set)
次要结局
- Change from baseline in forced expiratory volume in first second(FEV1) of Pre-dose and Pre-bronchodilator (Pre-BD).(Baseline up to Study Week 64)
- Mean Change From Baseline in Weekly Rescue Medication Use(Baseline up to Study Week 64)
- Change From Baseline in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb) .(Baseline up to Study Week 64)
- Time to First Asthma Exacerbation(Baseline up to Study Week 64)
- Mean Change From Baseline in Night Time Awakenings (Weekly Means)(Baseline up to Study Week 64)
- Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ(S)+12) Total Score(Baseline up to Study Week 64)
- abnormal laboratory test indicators(Baseline up to Study Week 64)
- Change From Baseline in Asthma Control Questionnaire-6(ACQ-6)(Baseline up to Study Week 64)
- Mean Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) (Weekly Means).(Baseline up to Study Week 64)
- Mean Change From Baseline in Asthma Symptom Diary(Baseline up to Study Week 52)
- Incidence and severity of adverse events (AE)(Baseline up to Study Week 64)
- Change From Baseline in Blood Eosinophils .(Baseline up to Study Week 64)
- Incidence and severity of serious adverse events (SAE)(Baseline up to Study Week 64)
- Change From Baseline in 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L) VAS(Baseline up to Study Week 64)
- Proportion of subjects with at least one asthma exacerbation(Baseline up to Study Week 64)
- Change From Baseline in Total Serum immunoglobulin E(IgE).(Baseline up to Study Week 64)