[{"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":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":27,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":27,"enrollmentInfo":44,"targetDuration":27,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":56,"whyStopped":27,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"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","phase-3-an-open-label-extension-study-of-treprostinil-palmitil-inhalation-powder-tpip-in-participants-with-pulmonary-hypertension-associated-with-interstitial-lung-disease-ph-ild-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":45,"type":46},344,"ESTIMATED","INTERVENTIONAL",[49],"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).",[52,53],"Pulmonary Hypertension","Interstitial Lung Disease",[55],"pulmonary hypertension, interstitial lung disease","NOT_YET_RECRUITING","2026-05-21",{"date":59,"type":60},"2026-05-26","ACTUAL",{"date":62,"type":46},"2026-06-05",{"date":64,"type":46},"2031-01-22",{"name":5,"class":6}]