NCT07761572尚未招募2 期
A Phase 2b, Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study, to Compare the Efficacy and Safety/Tolerability of CS1 Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 126
- 主要终点
- Change from baseline in pulmonary vascular resistance (PVR)
研究概览
简要总结
This Phase 2 study (EPIMODE) will evaluate the efficacy and safety of CS1 compared with placebo when added to standard-of-care therapy in participants with pulmonary arterial hypertension.
Participants completing Treatment Period 1 (Week 36) will be re-randomized to continue or switch study treatment for Treatment Period 2 through Week 52.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •WHO Group 1 pulmonary arterial hypertension
- •WHO Functional Class II or III
- •REVEAL Lite 2 score ≥6
- •Receiving stable standard-of-care PAH therapy for at least 90 days prior to screening
- •Hemodynamic confirmation of PAH by right heart catheterization
- •6-minute walk distance ≥150 m and <550 m
排除标准
- •Pulmonary hypertension WHO Group 2, 3, 4, or 5
- •Significant left-sided heart disease
- •Recent major cardiovascular or cerebrovascular event
- •Prior heart or heart-lung transplantation or active lung transplant listing
- •Significant renal or hepatic dysfunction
- •Current use of prohibited medications that cannot be discontinued
- •Pregnant or breastfeeding
研究组 & 干预措施
CS1 320 mg
Experimental
2 capsules of CS1 160 mg and 2 capsules of placebo
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
4 capsules of placebo
干预措施: Placebo (Drug)
CS1 640 mg
Experimental
4 capsules of CS1 160 mg
干预措施: CS1 (Drug)
CS1 320 mg
Experimental
2 capsules of CS1 160 mg and 2 capsules of placebo
干预措施: CS1 (Drug)
结局指标
主要结局
Change from baseline in pulmonary vascular resistance (PVR)
时间窗: Baseline to Week 36
Pulmonary vascular resistance calculated from right heart catheterization measurements using the Thermodilution or Fick method for determination of cardiac output.
次要结局
- Incidence of treatment-emergent adverse events (TEAEs)(Up to Week 56)
- Incidence of serious adverse events (SAEs)(Up to Week 56)
- Change from baseline in 6-minute walk distance (6MWD)(Baseline to Week 36)
- Change from baseline in Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management (REVEAL) Lite 2 score(Baseline to Week 36)
- Change from baseline in REVEAL Risk Score (RRS) 2.0(Baseline to Week 36)
- Change from baseline in tricuspid annular plane systolic excursion (TAPSE)(Baseline to Week 36)
- Change from baseline in right ventricular (RV) strain(Baseline to Week 36)
- Time to first clinical worsening event(Baseline through Week 36)
- Change from baseline in World Health Organization (WHO) Functional Class(Baseline to Week 36)
- Percentage of participants with improvement in WHO Functional Class(Week 36)
- Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) or B-type natriuretic peptide (BNP)(Baseline to Week 36)
- Change from baseline in mean pulmonary arterial pressure (mPAP)(Baseline to Week 36)
- Change from baseline in cardiac output (CO)(Baseline to Week 36)
- Percentage of participants with clinical worsening of pulmonary arterial hypertension (PAH)(Week 36)
- Change from baseline in PAH-SYMPACT (Pulmonary Arterial Hypertension Symptoms and Impact Questionnaire) domain scores(Baseline to Week 36)
- Change in 6MWD from Week 36(Week 36 to Week 52)
- Change in TAPSE from Week 36(Week 36 to Week 52)
- Change in RV strain from Week 36(Week 36 to Week 52)
- Change in NT-proBNP or BNP from Week 36(Week 36 to Week 52)
- Change in WHO Functional Class from Week 36(Week 36 to Week 52)
- Change in REVEAL Lite 2 score from Week 36(Week 36 to Week 52)
研究者
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