A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ENV-294 in Adult Participants With Moderate-to-Severe Asthma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 21
- 主要终点
- Incidence and Severity of Adverse Events
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of ENV-294 in adults with moderate to severe asthma who are receiving background treatment with inhaled corticosteroids (ICS) and long-acting beta₂-agonists (LABA).
Participants will take oral ENV-294 or placebo once daily for 12 weeks. The study includes a screening period of up to 28 days before randomization to confirm eligibility. Study visits and assessments will be conducted to monitor safety, measure drug levels in the blood, and evaluate effects on asthma control and lung function.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read, understand, and sign an informed consent form before any study procedures
- •Male or female adults aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least 12 months
- •Receiving stable treatment with an inhaled corticosteroid (ICS) plus a long-acting beta₂-agonist (LABA) for at least 2 months before screening
- •Pre-bronchodilator FEV₁ between 50% and 80% of predicted normal at screening and baseline
- •Demonstrated bronchodilator reversibility
- •ACQ-5 score ≥1.25 to ≤3.0 at screening and baseline
- •History of at least one asthma exacerbation in the past 12 months requiring systemic corticosteroids or hospitalization/emergency care
排除标准
- •Recent moderate or severe asthma exacerbation (within 4 weeks before screening)
- •History of life-threatening asthma
- •Other significant pulmonary disease
- •Recent bronchial thermoplasty (within 2 years)
- •Uncontrolled current or recurrent concomitant illness
- •Recent use of biologic therapies for asthma (within 6 months or 5 half-lives)
- •Require immunosuppressive medications or frequent systemic corticosteroids
- •Current smokers or former smokers with significant smoking history
- •Uncontrolled hypertension
- •Significant hepatic impairment
研究组 & 干预措施
Placebo Arm
A placebo will be administered to those participants randomized to the placebo arm.
干预措施: Placebo (Drug)
ENV-294 Treatment Arm
ENV-294 will be administered to those participants randomized to the treatment arm.
干预措施: ENV-294 (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events
时间窗: From first dose through approximately 16 weeks
Number and percentage of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study drug.
次要结局
- Loss of Asthma Control Events(Baseline to Week 12)
- Time to Loss of Asthma Control(Baseline to Week 12)
- To assess the efficacy of ENV-294 in participants with asthma(Baseline to Week 12)
- Plasma concentration of ENV-294(Baseline to Week 12)