A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 in Adults With Moderate-to-severe T2-high Asthma Who Are Partially Controlled on Inhaled Corticosteroid and Long-acting Beta 2 Agonist Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 29
- 主要终点
- Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed
研究概览
简要总结
Randomized, multi-center, double-blind, placebo-controlled, parallel group, proof of-concept study with RPT193 in subjects with T2-high, moderate-to-severe asthma who are partially controlled on medium or high doses of inhaled corticosteroids (ICS) in combination with long-acting beta 2 agonist (LABA).
详细描述
Randomized, multi-center, double-blind, placebo-controlled, parallel group, proof of-concept study with RPT193 in subjects with T2-high, moderate-to-severe asthma who are partially controlled on medium or high doses of inhaled corticosteroids (ICS) in combination with long-acting beta 2 agonist (LABA).
After a screening period subjects will receive standardized, inhaled therapy during a run-in period. Subjects will be randomized to receive RPT193 or placebo through Week 14. All enrolled subjects will receive background inhaled therapy with ICS and LABA.
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
- •Physician diagnosis of asthma for ≥6 months
- •Pre-bronchodilator FEV1 of >40% and <80%
- •History of treatment with corticosteroid or hospitalization for worsening asthma
- •Medium- or high-dose inhaled corticosteroid use
排除标准
- •History of smoking/vaping
- •History of severe COVID
- •Serious and/or uncontrolled pulmonary, cardiac, immune system conditions
- •Requires systemic oral or IV corticosteroids in the month prior to screening
研究组 & 干预措施
RPT193 400 mg
干预措施: RPT193 (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed
时间窗: 14 weeks
Participants experiencing LOAC events; ≥ 30% reduction in peak expiratory flow; ≥ 6 additional inhalations of short-acting beta 2 agonist; increase by factor of 4 or more of inhaled corticosteroids; and/or evidence of a severe asthma exacerbation
次要结局
- Change in FEV1 (L) of Week 14 Compared to Baseline(14 Weeks)
- Number of Participants With Non-serious Treatment-Emergent Adverse Events Experienced by ≥5% of Participants - Any TEAEs(14 weeks)