A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of PRA-216 in Participants With Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with chronic obstructive pulmonary disease (COPD).
详细描述
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of PRA-216, administered by SC injection in participants with moderate to severe COPD who are on standard of care treatment consisting of dual (ICS/LAMA or ICS/LABA) or triple inhaled maintenance therapy (ICS, LABA and LAMA).
The study will enroll approximately 40 participants at multiple study site and participants will be randomized 1:1 to receive either PRA-216 or placebo subcutaneous injections four times throughout the study 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
- •Age 40-80
- •Willing and able to attend all study visits, comply with study requirements.
- •Able and willing to provide written informed consent
- •Documented COPD diagnosis prior for at least 12 months prior to screening.
- •Currently receiving maintenance COPD medications at a stable dose for at least 2 months prior to visit 1
排除标准
- •Evidence of clinically significant pulmonary condition or disease other than COPD
- •Any physical or psychological condition that prohibits study completion
- •Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism within 12 months prior to the first dose of study agent
- •History of severe allergic reactions or hypersensitivity
- •Receipt of immunosuppressant therapies for asthma within 3 months of screening
- •Major surgery occurring within 8 weeks months prior to first dose of investigational product.
- •Use of any marketed or investigational monoclonal or polyclonal antibody therapy within 4 months or 5 half-lives prior to visit 1.
结局指标
主要结局
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
时间窗: 40 weeks
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of PRA-216 in patients with moderate to severe COPD
次要结局
- The effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in COPD participants(40 weeks)
- Pharmacokinetics of PRA-216: T1/2 in patients with COPD(40 weeks)
- Pharmacokinetics of PRA-216: AUC in patients with COPD(40 weeks)
- Pharmacokinetics of PRA-216: Cmax in patients with COPD(40 weeks)
- Immunogenicity of PRA-216: ADA in patients with COPD(40 weeks)