NCT07039669招募中3 期
A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 594
- 试验地点
- 4
- 主要终点
- Annualized rate of moderate or severe COPD Exacerbations
研究概览
简要总结
The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.
详细描述
The maximum study duration was 66 weeks per participants, including a screening period of up to 6 weeks, a 52-week randomized treatment period, and a 8-week follow-up period.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
- •Male or female adults ages 40 to 85 years old when signing the informed consent.
- •Current or former smokers with a smoking history of ≥10 pack-years.
- •Documented diagnosis of COPD for at least 12 months prior to enrolment
- •Moderate-to-severe COPD.
- •Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
- •Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥ 1 month prior to randomization; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
- •Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose.
排除标准
- •Presence of a known pre-existing, clinically important lung condition other than COPD.
- •A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
- •Diagnosis of α-1 anti-trypsin deficiency.
- •Presence of an active autoimmune disease.
- •Subjects who have any malignant tumors within 5 years prior to enrollment.
- •Known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled.
- •Diagnosed active parasitic infection, suspected or high risk of parasitic infection.
- •Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- •Known with allergic or intolerant to any biological product.
- •Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.
研究组 & 干预措施
611
Experimental
611 Q2W, subcutaneous (SC) injection
干预措施: 611 (Drug)
placebo
Placebo Comparator
placebo Q2W, subcutaneous (SC) injection
干预措施: Placebo (Drug)
结局指标
主要结局
Annualized rate of moderate or severe COPD Exacerbations
时间窗: Baseline to Week 52
Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) event that required systemic corticosteroids with/without antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death.
次要结局
- Change from baseline in pre-bronchodilator FEV1 at Week 24(Baseline, Week 24)
- Change from baseline in pre-bronchodilator FEV1(Baseline to Week 52)
- Change from baseline in post-bronchodilator FEV1(Baseline to Week 52)
- 611 Concentration in Serum(Baseline to Week 60)
- Change in serum concentrations of Pulmonary and activation-regulated chemokine (PARC)(Baseline to Week 60)
- Change in serum concentrations of IgE(Baseline to Week 60)
- Time to first Moderate or severe COPD exacerbation(Baseline to Week 52)
- Change from baseline in SGRQ scores(Baseline to Week 52)
- Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline(Baseline to Week 16)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)(Up to 60 Weeks)
- Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies(Baseline to Week 60)
- Annualized rate of severe COPD Exacerbations(Baseline to Week 52)
研究者
研究点 (4)
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