NCT07234032招募中3 期
A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 344
- 试验地点
- 9
- 主要终点
- Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380).
- •Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study.
排除标准
- •Participants who experienced any adverse events (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant.
- •Current use or expected need for pulmonary arterial hypertension (PAH)-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed.
- •Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema).
- •Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH.
- •Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine).
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Treprostinil Palmitil Inhalation Powder (TPIP)
Experimental
Participants transitioning from study INS1009-311 (NCT07179380) will undergo an initial double-dummy titration with the stable dose from the lead-in study and either TPIP or placebo for 4 weeks. They will then receive open-label TPIP at a stable maintenance dose with optional escalation (80-1280 micrograms once daily) for the remainder of the 104-week treatment period.
干预措施: Placebo (Drug)
Treprostinil Palmitil Inhalation Powder (TPIP)
Experimental
Participants transitioning from study INS1009-311 (NCT07179380) will undergo an initial double-dummy titration with the stable dose from the lead-in study and either TPIP or placebo for 4 weeks. They will then receive open-label TPIP at a stable maintenance dose with optional escalation (80-1280 micrograms once daily) for the remainder of the 104-week treatment period.
干预措施: Treprostinil Palmitil Inhalation Powder (Drug)
结局指标
主要结局
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 108 weeks
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 108 weeks
次要结局
- Change From Baseline in 6-Minute Walk Distance (6MWD) Measured Post-Dose(Up to 104 weeks)
- Absolute Change From Baseline in Forced Vital Capacity (FVC)(Up to 104 weeks)
- Percent Change From Baseline in Forced Vital Capacity (FVC)(Up to 104 weeks)
- Absolute Change From Baseline in Percent Predicted FVC (FVC% pred)(Up to 104 weeks)
- Percent Change From Baseline in Percent Predicted FVC (FVC% pred)(Up to 104 weeks)
- Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)(Up to 104 weeks)
- Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)(Up to 104 weeks)
- Absolute Change From Baseline in Percent Predicted FEV1 (FEV1%)(Up to 104 weeks)
- Percent Change From Baseline in Percent Predicted FEV1 (FEV1%)(Up to 104 weeks)
- Change From Baseline in the Plasma Concentration of N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP)(Up to 104 weeks)
- Annualized Rate of Occurrence of Exacerbations of Interstitial Lung Disease (ILD)(Up to 104 weeks)
- Percentage of Participants With a Clinical Worsening Events(Up to 104 weeks)
- Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Domain Score(Up to 104 weeks)
- Mean Change From Baseline in L-PF Cough Domain Score(Up to 104 weeks)
- Mean Change From Baseline in L-PF Dyspnea Domain Score(Up to 104 weeks)
- Mean Change From Baseline in L-PF Impact Domain Score(Up to 104 weeks)
- Mean Change From Baseline in the EuroQoL- 5 Dimensions (EQ-5D-5L) Index Score(Up to 104 weeks)
- Mean Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS)(Up to 104 weeks)
- Percentage of Participants With Major Morbidity or Mortality Events(Up to 104 weeks)
- Change From Baseline in 6-Minute Walk Distance (6MWD) Measured Post-Dose(Up to 104 weeks)
- Absolute Change From Baseline in Forced Vital Capacity (FVC)(Up to 104 weeks)
- Percent Change From Baseline in Forced Vital Capacity (FVC)(Up to 104 weeks)
- Absolute Change From Baseline in Percent Predicted FVC (FVC% pred)(Up to 104 weeks)
- Percent Change From Baseline in Percent Predicted FVC (FVC% pred)(Up to 104 weeks)
- Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)(Up to 104 weeks)
- Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)(Up to 104 weeks)
- Absolute Change From Baseline in Percent Predicted FEV1 (FEV1%)(Up to 104 weeks)
- Percent Change From Baseline in Percent Predicted FEV1 (FEV1%)(Up to 104 weeks)
- Change From Baseline in the Plasma Concentration of N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP)(Up to 104 weeks)
- Annualized Rate of Occurrence of Exacerbations of Interstitial Lung Disease (ILD)(Up to 104 weeks)
- Percentage of Participants With a Clinical Worsening Events(Up to 104 weeks)
- Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Domain Score(Up to 104 weeks)
- Mean Change From Baseline in L-PF Cough Domain Score(Up to 104 weeks)
- Mean Change From Baseline in L-PF Dyspnea Domain Score(Up to 104 weeks)
- Mean Change From Baseline in L-PF Impact Domain Score(Up to 104 weeks)
- Mean Change From Baseline in the EuroQoL- 5 Dimensions (EQ-5D-5L) Index Score(Up to 104 weeks)
- Mean Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS)(Up to 104 weeks)
- Percentage of Participants With Major Morbidity or Mortality Events(Up to 104 weeks)
研究者
研究点 (9)
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