NCT06707883进行中（未招募）2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.60 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2024年12月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 258
- 试验地点
- 60
- 主要终点
- Annual rate of acute COPD exacerbation
研究概览
简要总结
To evaluate the efficacy and safety of TQC2731 injection in patients with moderate to severe chronic obstructive pulmonary disease.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide written informed consent and comply with the study protocol;
- •Participant must be ≥40 to ≤80 years of age at the time of signing informed consent.
- •Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease(COPD) and a history of COPD ≥12 months with medical records or related records at the time of screening;
- •Post-bronchodilator FEV1/Forced vital capacity (FVC)<0.70 and post-bronchodilator FEV1 % predicted ≥20% and < 80% during screening.
- •Modified Medical Research Council (mMRC) Dyspnea Scale grade≥2 during screening.
- •Background triple therapy (ICS+long-acting beta-agonists (LABA)+LAMA) for at least 3 months with a stable dose for at least 1 month prior to randomization; Double therapy allowed if ICS is contraindicated.
- •With a history of acute exacerbation of ≥2 moderate or ≥1 severe within the previous 12 months prior to screening. Multiple acute exacerbation events with an interval of less than 14 days are counted as one.
排除标准
- •COPD with asthma;
- •Subjects with active pulmonary diseases other than COPD assessed by the investigator.
- •Moderate to severe Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) occurred within 4 weeks prior to screening or during screening;
- •History of lung transplantation;
- •Previous use of TQC
- •Diagnosis of alpha-1 anti-trypsin deficiency;
- •History of lung volume reduction surgery or pneumonectomy within 6 months prior to randomization, or planned lung volume reduction surgery during the study period;
- •Positive hepatitis B surface antigen, or hepatitis C virus antibody, or syphilis antibody.
- •Diagnosis of immunodeficiency, including but not limited to HIV infection;
- •Infection requiring systemic therapy within 2 weeks prior to randomization.
- •Starting rehabilitation within 4 weeks prior to randomization, or planned rehabilitation during the study period;
- •Treatment with oxygen of more than 12 hours per day.
- •Heart failure New York Heart Association (NYHA) class III or IV during the screening period.
- •History of malignancy within 5 years prior to screening, excluding cervical carcinoma in situ, ductal carcinoma in situ, etc.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
TQC2731 injection
Experimental
TQC2731 injection, 28days as a treatment cycle.
干预措施: TQC2731 injection (Drug)
TQC2731 Placebo
Placebo Comparator
TQC2731 Placebo, 28days as a treatment cycle.
干预措施: TQC2731 Placebo (Drug)
结局指标
主要结局
Annual rate of acute COPD exacerbation
时间窗: Baseline to week 24
Annualized rate of moderate or severe COPD exacerbations over the 24-week treatment period compared to placebo
次要结局
- Change in pre-bronchodilator forced expiratory volume (FEV1)(Baseline to week 24)
- Annual rate of acute COPD exacerbation(Baseline to week 52)
- Improvement in St. George's Respiratory Questionnaire (SGRQ)(Baseline to week 52)
- Change in SGRQ(Baseline to week 52)
- Change in pre-bronchodilator FEV1(Baseline to week 52)
- Change in post-bronchodilator FEV1(Baseline to week 24 and 52)
- Change in EXACT(Baseline to week 52)
- Adverse Events (AE) and Serious Adverse Events (SAE)(Baseline to 64 weeks)
- Anti-drug antibodies (ADA)(Baseline through week 52)
- Immunoglobulin E (IgE)(Baseline to 52 weeks)
- Fractional exhaled nitric oxide (FeNO)(Baseline to 52 weeks)
研究者
研究点 (60)
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