[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610934":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":128,"collaborators":27,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":27,"eligibilityCriteria":136,"healthyVolunteers":132,"sex":137,"minAge":138,"maxAge":27,"enrollmentInfo":139,"targetDuration":27,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":40,"whyStopped":27,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"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":30,"affiliation":5,"role":31},"Study Director","STUDY_DIRECTOR",[33],{"name":5,"role":34,"phone":35,"phoneExt":27,"email":36},"CONTACT","18444467633","medicalinformation@insmed.com",[38,52,62,75,85,91,102,108,117],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":27},"USA006","RECRUITING","Naples","Florida","34102","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-81.79596,26.14234,{"lat":50,"lon":49},{"facility":53,"status":40,"city":54,"state":55,"zip":56,"country":44,"countryCode":45,"cosmosGeoPoint":57,"geoPoint":61,"contacts":27},"USA003","Bend","Oregon","97701",{"type":47,"coordinates":58},[59,60],-121.31531,44.05817,{"lat":60,"lon":59},{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":27},"JPN004","NOT_YET_RECRUITING","Narita","Chiba","286-8520","Japan","JP",{"type":47,"coordinates":71},[72,73],140.31667,35.78333,{"lat":73,"lon":72},{"facility":76,"status":64,"city":77,"state":27,"zip":78,"country":79,"countryCode":27,"cosmosGeoPoint":80,"geoPoint":84,"contacts":27},"KOR001","Seoul","3080","South Korea",{"type":47,"coordinates":81},[82,83],126.9784,37.566,{"lat":83,"lon":82},{"facility":86,"status":64,"city":77,"state":27,"zip":87,"country":79,"countryCode":27,"cosmosGeoPoint":88,"geoPoint":90,"contacts":27},"KOR006","6351",{"type":47,"coordinates":89},[82,83],{"lat":83,"lon":82},{"facility":92,"status":64,"city":93,"state":27,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":27},"ESP006","Madrid","28041","Spain","ES",{"type":47,"coordinates":98},[99,100],-3.70256,40.4165,{"lat":100,"lon":99},{"facility":103,"status":64,"city":93,"state":27,"zip":104,"country":95,"countryCode":96,"cosmosGeoPoint":105,"geoPoint":107,"contacts":27},"ESP003","28046",{"type":47,"coordinates":106},[99,100],{"lat":100,"lon":99},{"facility":109,"status":64,"city":110,"state":27,"zip":111,"country":95,"countryCode":96,"cosmosGeoPoint":112,"geoPoint":116,"contacts":27},"ESP001","Seville","41009",{"type":47,"coordinates":113},[114,115],-5.97317,37.38283,{"lat":115,"lon":114},{"facility":118,"status":64,"city":119,"state":27,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":127,"contacts":27},"TWN003","Hsinchu","30059","Taiwan","TW",{"type":47,"coordinates":124},[125,126],120.96861,24.80361,{"lat":126,"lon":125},{"type":129,"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":140,"type":141},344,"ESTIMATED","INTERVENTIONAL",[144],"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).",[147,148],"Pulmonary Hypertension","Interstitial Lung Disease",[150],"pulmonary hypertension, interstitial lung disease","2026-08-11",{"date":153,"type":154},"2026-08-13","ACTUAL",{"date":156,"type":154},"2026-07-20",{"date":158,"type":141},"2031-01-22",{"name":5,"class":6},9]