[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610934":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":28,"locations":27,"responsibleParty":33,"collaborators":27,"id":35,"slug":27,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":27,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":27,"enrollmentInfo":43,"targetDuration":27,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":55,"whyStopped":27,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":27},{"fullName":5,"class":6},"Insmed Incorporated","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Drug: Treprostinil Palmitil Inhalation Powder","Drug: Placebo",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Treprostinil Palmitil Inhalation Powder","Oral inhalation using a capsule-based dry powder.",[9],[22],"INS1009",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Placebo","Oral inhalation in initial double-dummy titration period.",[9],null,[29],{"name":5,"role":30,"phone":31,"phoneExt":27,"email":32},"CONTACT","18444467633","medicalinformation@insmed.com",{"type":34,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100610934",false,"NCT07234032","An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)","A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease","Inclusion Criteria\n\n* Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380).\n* 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.\n* Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study.\n\nExclusion Criteria\n\n* 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.\n* 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\u002For soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed.\n* 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).\n* Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH.\n* Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine).\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":44,"type":45},344,"ESTIMATED","INTERVENTIONAL",[48],"PHASE3","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).",[51,52],"Pulmonary Hypertension","Interstitial Lung Disease",[54],"pulmonary hypertension, interstitial lung disease","NOT_YET_RECRUITING","2026-05-21",{"date":58,"type":59},"2026-05-26","ACTUAL",{"date":61,"type":45},"2026-06-05",{"date":63,"type":45},"2031-01-22",{"name":5,"class":6}]