A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants With Chronic Obstructive Pulmonary Disease (ZION)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 182
- 试验地点
- 265
- 主要终点
- Change from baseline in blood eosinophil counts
研究概览
简要总结
A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (COPD).
详细描述
This is a 12-week randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 2 dose levels of solrikitug versus placebo on top of standard of care in participants with COPD.
Approximately 171 eligible participants with COPD will be randomized at approximately 60-90 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 12-week treatment period. The study also includes a post-treatment follow-up period of 16 weeks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 40 years of age and no older than 75 years.
- •Documented diagnosis of COPD for at least 12 months prior to Screening, defined by the GOLD Guidelines (2023), and elevated blood eosinophils at screening.
- •At Screening FEV1/FVC ratio must be <0.70, and Post-bronchodilator FEV1 must be ≥40% to <80% predicted normal value calculated using Global Lung Function Initiative (GLI) reference equations (Cooper et al 2017).
- •Symptomatic (COPD Assessment Test [CAT] Score ≥10) at Screening Visit
- •Participants must be on 2 or more inhaled maintenance medications for management of their COPD, for at least 3 months prior to screening.
排除标准
- •Female participant who is pregnant or breastfeeding.
- •Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody.
- •Participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the Investigator or Medical Monitor might obfuscate the study data.
- •Any other pulmonary disease than COPD that in the opinion of the Investigator, the severity of the disorder would impact the conduct of the study.
- •Undergone major lung surgery, within 1 year of Screening Visit
- •Participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to Screening.
研究组 & 干预措施
Biological: Solrikitug High Dose
Solrikitug
干预措施: Biological: Solrikitug high dose (Biological)
Biological: Solrikitug Low Dose
Solrikitug
干预措施: Biological: Solrikitug low dose (Biological)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in blood eosinophil counts
时间窗: Through week 12
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo
次要结局
- Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs)(Through week 12 To week 28)