A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Trepostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

You likely can't join if

• • Diagnosis of PH WHO Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than Interstitial lung disease as described in Inclusion criterion 2 • Primary diagnosis of COPD and/or FEV1/FVC <0.7 (based on screening or historical spirometry within the prior 6 months)
• • Clinically significant left heart disease: • evidence of clinically significant left-sided valvular heart disease, • left ventricular failure with LVEF <45%, or diagnosis of HFpEF • echocardiography findings at Screening suggestive for postcapillary PH • unstable ischemic heart disease • unstable arrhythmia, including uncontrolled atrial fibrillation (rate-controlled arrhythmia or paroxysmal atrial fibrillation is allowed). • Acutely decompensated heart failure within 30 days of Screening or during Screening. • QTcF interval >500 ms at Screening or Baseline, or known medical history of long QT syndrome. • Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism.
• •Platelet count <50.0 x 103/μL at Screening, and/or unexplained coagulation abnormalities in repeated laboratory tests during the screening. •Systolic BP <90 mmHg at Screening and Baseline. •Supplemental oxygen requirement at rest >10 L/min at Screening (otherwise use of supplemental oxygen is allowed). •Active cardiopulmonary rehabilitation program started within 30 days of Screening and planned to continue or be initiated during the study. •Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine). •Exacerbation of underlying lung disease or active respiratory tract infection within 30 days of Screening or during Screening (based on the last dose of therapy or hospitalization, whichever is later).
• •Any acute or chronic musculoskeletal disease, injury, or other condition (eg, arthritis affecting the lower limbs, recent hip or knee joint replacement), other than the disease under study that, in the opinion of the Investigator, might affect the participant’s ability to perform the 6MWT and/or the 6MWT accuracy. •Active liver disease or hepatic dysfunction: • Elevated serum ALT or AST levels >3 × ULN or total bilirubin >1.5 × ULN (except when explained by Gilbert's syndrome) at Screening • Moderate to severe chronic hepatic impairment (Child-Pugh Class B-C) • Hepatitis B and/or hepatitis C with evidence of recent infection and/or active virus replication (participant with undetectable hepatitis B virus DNA and negative hepatitis C virus RNA are acceptable)
• •History of HIV infection or positive serology for HIV-1 or HIV-2. •Severe concomitant illness (other than the disease under study) limiting life expectancy (<6 months). •History of solid organ transplantation, or expected transplant within 24 weeks after randomization(otherwise participant on lung transplant list are accepted). •Any physical limitation that would impair the participant's use of the inhaler device. •Use of any investigational drug/device, or participation in any investigational study within 30 days prior to Screening. •History of alcohol or drug abuse, as judged by the Investigator, within 6 months prior to Screening. •Current use of cigarettes (as defined by CDC) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days (Glossary, CDC Tobacco Glossary, 2017).
• •Current use of inhaled marijuana, recreational or medical (current use defined as used at least one or more times during the past 30 days prior to Screening), or expected use during the study. •Any other medical or psychological condition including relevant laboratory abnormalities at Screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease and/or may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial. •History of malignancy within 5 years prior to Screening Visit, with exception of completely treated in situ carcinoma of the cervix, in situ melanoma, and completely treated non-metastatic squamous or basal cell carcinoma of the skin. •Pregnant or breastfeeding.