NCT07349524招募中2 期
Evaluation of the Efficacy and Safety of RSS0343 Tablets in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Phase II, Randomized, Double-blind, Placebo-controlled Clinical Study.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of RSS0343 tablets in patients with COPD. The study includes 3 study periods: a 4-week screening period, a 48-week treatment period, and a 4-week follow-up period. The primary endpoint is the annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign a written informed consent form.
- •Aged 40 to 80 years, male or female.
- •Body mass index (BMI) ≥18 kg/m².
- •Diagnosed with chronic obstructive pulmonary disease (COPD) as defined by the Chinese Guidelines for the Diagnosis and Management of COPD (2021 Revised Edition), with a documented COPD history of ≥12 months prior to screening.
- •Post-bronchodilator FEV₁/FVC <0.7 at the screening period; and post-bronchodilator FEV₁/FVC <0.7 with FEV₁% predicted ≥20% at baseline.
- •Documented history of at least ≥1 moderate or severe acute exacerbation of COPD (AECOPD) within 12 months prior to screening.
- •On stable doses of triple therapy or dual therapy for COPD maintenance treatment for ≥3 months prior to screening.
- •COPD Assessment Test (CAT) score ≥10 at screening and randomization.
- •Current or former smoking history of ≥10 pack-years at screening.
- •Male and female subjects of childbearing potential and their partners must have no plans for conception or sperm/ova donation for 6 months (female subjects) or 3 months (male subjects) after the last dose and must voluntarily use effective contraception. Female subjects of childbearing potential must have a negative pregnancy test during screening and prior to the first dose and must not be lactating.
排除标准
- •Subjects with systemic immunosuppressants, biologic agents, or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug, whichever is longer.
- •Subjects with medications known to potentially cause skin hyperkeratosis within 4 weeks prior to screening.
- •Subjects with the followings within 4 weeks prior to randomization: systemic corticosteroids, phosphodiesterase inhibitors, xanthine derivatives, leukotriene receptor antagonists, bacterial lysates, antitussive/expectorant medications, infusion of blood products or immunoglobulins.
- •Subjects with strong CYP3A inducers or inhibitors within 14 days or 5 half-lives (whichever is longer) prior to randomization.
- •Administration of live, attenuated live, or viral vector vaccines within 4 weeks prior to randomization.
- •Participation in another clinical trial involving an investigational product with active ingredients within 3 months prior to screening, or still within 5 half-lives of the investigational product at screening.
- •Prior treatment with RSS0343 tablets or treatment with products targeting the same mechanism of action within 3 months prior to screening.
- •Lung surgery or lung volume reduction surgery within 1 year prior to screening; or interventional procedures for chronic bronchitis within 1 year prior to screening.
- •Requirement for supplemental oxygen therapy for ≥15 hours per day or mechanical ventilation; or clinically significant sleep apnea requiring the use of a continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
- •Presence of a moderate or severe acute exacerbation of COPD (AECOPD) from 4 weeks prior to screening up to randomization.
- •Coexisting other respiratory or respiratory-related diseases.
- •Occurrence of pulmonary or other infections requiring systemic anti-infective therapy from 4 weeks prior to screening up to randomization.
- •Presence of autoimmune diseases mediated by eosinophils at screening.
- •Diagnosis of hypothyroidism, myxedema, chronic lymphedema, acromegaly, or livedo reticularis.
- •Diagnosis of psoriasis or lichen planus; Reiter's disease/keratoderma blennorrhagicum, keratoderma hemorrhagicum, or reactive arthritis; systemic lupus erythematosus, atopic dermatitis, chronic hand dermatitis, chronic contact dermatitis, or chronic psoriasis; chloracne, extensive verruca vulgaris, or keratotic dermatitis.
- •Known other severe medical conditions.
- •Laboratory tests, electrocardiogram (ECG), or other auxiliary examinations during the screening or baseline periods meeting the protocol-defined exclusion criteria.
- •Suspected or known hypersensitivity to the investigational product or any of its excipients.
- •Blood donation or blood loss ≥200 mL within 1 month prior to randomization, or ≥400 mL within 3 months prior to the first dose; or receipt of a blood transfusion within 8 weeks prior to the first dose; or difficulty with venipuncture, or physical condition unsuitable for intensive blood sampling.
- •Female subjects who are lactating, have a positive pregnancy test result, or plan to become pregnant during the study period.
- •History of drug abuse or substance abuse within 1 year prior to screening.
- •Any other medical or social reason deemed by the investigator to make the subject unsuitable for participation in the trial.
研究组 & 干预措施
RSS0343 tablets
Experimental
干预措施: RSS0343 tablets (Drug)
RSS0343 tablets Placebo
Placebo Comparator
干预措施: RSS0343 tablets Placebo (Drug)
结局指标
主要结局
Annualized rate of moderate or severe exacerbations of COPD during the 48-week treatment period
时间窗: during the 48-week treatment period
次要结局
- The annualized rate of moderate or severe exacerbations of COPD at week 12, 24, and 36；(at week 12, 24, and 36;)
- The annualized rate of moderate or severe exacerbations of COPD at week 12, 24, 36, and 48;(at week 12, 24, 36, and 48;)
- The time to first moderate or severe exacerbations of COPD at week 24 and 48;(at week 24 and 48;)
- The proportion of patients experiencing moderate or severe exacerbations of COPD at week 24 and 48(at week 24 and 48)
- The change from baseline in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV₁) at week 4, 8, 12, 24, 36, 48, and 52(at week 4, 8, 12, 24, 36, 48, and 52)
- The change from baseline in pre- and post-bronchodilator forced expiratory volume in FEV₁% predicted at week 4, 8, 12, 24, 36, 48, and 52(at week 4, 8, 12, 24, 36, 48, and 52)
- The change from baseline in pre- and post-bronchodilator forced expiratory volume in forced vital capacity (FVC) at week 4, 8, 12, 24, 36, 48, and 52;(at week 4, 8, 12, 24, 36, 48, and 52;)
- The change from baseline in the COPD Assessment Test (CAT) score at week 4, 8, 12, 24, 36, 48, and 52(at week 4, 8, 12, 24, 36, 48, and 52)
- The change from baseline in the Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score at week 4, 8, 12, 24, 36, 48, and 52(at week 4, 8, 12, 24, 36, 48, and 52)
- The change from baseline in the St. George's Respiratory Questionnaire (SGRQ) score at week 4, 8, 12, 24, 36, 48, and 52;(at week 4, 8, 12, 24, 36, 48, and 52;)
- The proportion of patients with a SGRQ response (a ≥4-point decrease from baseline) at week 48;(at week 48;)
研究者
研究点 (1)
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