[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07473700":3,"trial-entities:NCT07473700":202,"trial-summary:NCT07473700":207},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":47,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":15,"eligibility_criteria":69,"std_ages":80,"locations":83,"central_contacts":193,"overall_officials":199,"references":200,"see_also_links":201},"NCT07473700","TX000045-004","Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease","An Open-Label Study to Assess the Hemodynamic Effect and the Safety of TX000045 After 16 Weeks of Treatment in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease","RECRUITING","2027-12-11","2026-07","2026-07-27","2026-08","Tectonic Operating Company, Inc.","INDUSTRY",false,"The primary purpose of this study is to assess the effect of TX000045 on pulmonary vascular resistance (PVR) in participants with pulmonary hypertension secondary to interstitial lung disease (PH-ILD) and to assess the safety and tolerability of TX000045 in participants with PH-ILD.",null,[19,20],"Hypertension, Pulmonary","Lung Diseases, Interstitial",[22,23],"Interstitial lung disease","pulmonary vascular resistance","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},25,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","TX000045","Subcutaneous Injection.",[37],"TX000045 300 mg",[39,42,45],{"measure":40,"timeFrame":41},"Mean Change from Baseline in PVR up to 16 Weeks","Baseline up to 16 weeks",{"measure":43,"timeFrame":44},"Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)","Baseline up to 21 weeks",{"measure":46,"timeFrame":44},"Number of Participants with Clinically Significant Changes from Baseline in Safety Laboratory Assessments, 12-Lead Electrocardiogram (ECG) Assessments and Vital Sign Assessments",[48,50,52,54,56,58,60,62,64],{"measure":49,"timeFrame":44},"Mean Change from Baseline in Mean Pulmonary Arterial Pressure (mPAP) up to 21 Weeks",{"measure":51,"timeFrame":44},"Mean Change from Baseline in Hemodynamic Parameter: Pulmonary Capillary Wedge Pressure (PCWP)",{"measure":53,"timeFrame":44},"Mean Change from Baseline in Hemodynamic Parameter: Cardiac Output (CO)",{"measure":55,"timeFrame":44},"Mean Change from Baseline in Hemodynamic Parameter: Stroke Volume (SV)",{"measure":57,"timeFrame":44},"Mean Change from Baseline in Resting Arterial Oxygen Saturation (SpO2) up to 21 Weeks",{"measure":59,"timeFrame":44},"Mean Change from Baseline in Supplemental Oxygen Requirement (L\u002Fmin) up to 21 Weeks",{"measure":61,"timeFrame":44},"Mean Change from Baseline in the Nadir of the SpO2 During the 6-minute walk test (6MWT) up to 21 Weeks",{"measure":63,"timeFrame":44},"Mean Change from Baseline in Oxygen Saturation (SpO2)at 1, 2, and 3 Minutes after Completion of the 6-MWT up to 21 Weeks",{"measure":65,"timeFrame":44},"Mean Change from Baseline in Distance Walked During the 6MWT at Which an Absolute Decrease of SpO2>4% for At least 15 Second","ALL","18 Years","80 Years",{"inclusion":70,"exclusion":74,"raw_text":79},[71,72,73],"Confirmed diagnosis of ILD based on imaging: chest computed tomography (CT) performed within the past 12 months with fibrotic lung disease (greater than or equal to (\\>=) 10 percent (%) lung parenchyma with fibrosis) consistent with idiopathic interstitial pneumonia, ILD in association with connective tissue disease, occupational ILD, or chronic hypersensitivity pneumonitis. Chest CTs will be centrally read for eligibility","40% predicted less than or equal to (\\\u003C=) forced vital capacity (FVC) \\\u003C= 80% predicted at screening","At least ONE of the following is required to undergo the first screening visit: Documented diagnostic right heart catheterization (RHC) within 18 months of screening with mean pulmonary arterial pressure (mPAP) \\>= 25 millimeters of mercury (mm Hg), pulmonary capillary wedge pressure (PCWP) \\\u003C=15 mm Hg, and pulmonary vascular resistance (PVR) \\>=4 Wood units; Documented echocardiogram (ECHO) within 18 months of screening with right ventricular (RV) (or pulmonary artery) systolic pressure \\>46 mm Hg or tricuspid annular plane systolic excursion (TAPSE)\u002F systolic pulmonary artery pressure (SPAP) \\\u003C=0.38 and absence of clinically significant left ventricular dysfunction as assessed by the investigator",[75,76,77,78],"Participants have a confirmed or suspected diagnosis of pulmonary hypertension in World Health Organization (WHO) Group 1, WHO Group 2, WHO Group 4, or WHO Group 5","Participants have received phosphodiesterase type 5 inhibitors, endothelin receptor antagonists, soluble guanylate cyclase stimulators, intravenous (IV) or subcutaneous (SC) prostacyclin analogues within 30 days before the first screening visit, or sotatercept within 180 days before the first screening visit","Participants have any type of pulmonary and cardiovascular comorbidities as defined n protocol","Participants who are taking disease-modifying therapy for the underlying interstitial lung disease (ILD) (anti-fibrotics, immunosuppressives, and anti-inflammatory medications) who are not on stable doses for \\>30 days before the first screening visit or have initiated new ILD-directed therapies within 90 days before the first screening visit","Inclusion Criteria:\n\n* Confirmed diagnosis of ILD based on imaging: chest computed tomography (CT) performed within the past 12 months with fibrotic lung disease (greater than or equal to (\\>=) 10 percent (%) lung parenchyma with fibrosis) consistent with idiopathic interstitial pneumonia, ILD in association with connective tissue disease, occupational ILD, or chronic hypersensitivity pneumonitis. Chest CTs will be centrally read for eligibility\n* 40% predicted less than or equal to (\\\u003C=) forced vital capacity (FVC) \\\u003C= 80% predicted at screening\n* At least ONE of the following is required to undergo the first screening visit: Documented diagnostic right heart catheterization (RHC) within 18 months of screening with mean pulmonary arterial pressure (mPAP) \\>= 25 millimeters of mercury (mm Hg), pulmonary capillary wedge pressure (PCWP) \\\u003C=15 mm Hg, and pulmonary vascular resistance (PVR) \\>=4 Wood units; Documented echocardiogram (ECHO) within 18 months of screening with right ventricular (RV) (or pulmonary artery) systolic pressure \\>46 mm Hg or tricuspid annular plane systolic excursion (TAPSE)\u002F systolic pulmonary artery pressure (SPAP) \\\u003C=0.38 and absence of clinically significant left ventricular dysfunction as assessed by the investigator\n\nExclusion Criteria:\n\n* Participants have a confirmed or suspected diagnosis of pulmonary hypertension in World Health Organization (WHO) Group 1, WHO Group 2, WHO Group 4, or WHO Group 5\n* Participants have received phosphodiesterase type 5 inhibitors, endothelin receptor antagonists, soluble guanylate cyclase stimulators, intravenous (IV) or subcutaneous (SC) prostacyclin analogues within 30 days before the first screening visit, or sotatercept within 180 days before the first screening visit\n* Participants have any type of pulmonary and cardiovascular comorbidities as defined n protocol\n* Participants who are taking disease-modifying therapy for the underlying interstitial lung disease (ILD) (anti-fibrotics, immunosuppressives, and anti-inflammatory medications) who are not on stable doses for \\>30 days before the first screening visit or have initiated new ILD-directed therapies within 90 days before the first screening visit",[81,82],"ADULT","OLDER_ADULT",[84,92,99,107,114,121,127,133,140,147,154,160,168,174,181,187],{"facility":85,"status":8,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"Phoenix","Arizona","85020","United States",{"lat":90,"lon":91},33.44838,-112.07404,{"facility":93,"status":8,"city":93,"state":94,"zip":95,"country":88,"geoPoint":96},"San Francisco","California","94143",{"lat":97,"lon":98},37.77493,-122.41942,{"facility":100,"status":101,"city":102,"state":100,"zip":103,"country":88,"geoPoint":104},"Idaho","NOT_YET_RECRUITING","Idaho Falls","83706",{"lat":105,"lon":106},43.46658,-112.03414,{"facility":108,"status":101,"city":108,"state":109,"zip":110,"country":88,"geoPoint":111},"Allen Park","Michigan","48101",{"lat":112,"lon":113},42.25754,-83.21104,{"facility":115,"status":101,"city":115,"zip":116,"country":117,"geoPoint":118},"Krakow","31-202","Poland",{"lat":119,"lon":120},50.06143,19.93658,{"facility":122,"status":101,"city":122,"zip":123,"country":117,"geoPoint":124},"Lublin","20-950",{"lat":125,"lon":126},51.25058,22.57009,{"facility":128,"status":101,"city":128,"zip":129,"country":117,"geoPoint":130},"Wroclaw","50-556",{"lat":131,"lon":132},51.10286,17.03006,{"facility":134,"status":101,"city":134,"zip":135,"country":136,"geoPoint":137},"Bucharest","50159","Romania",{"lat":138,"lon":139},44.43225,26.10626,{"facility":141,"status":101,"city":141,"zip":142,"country":143,"geoPoint":144},"Belgrade","11000","Serbia",{"lat":145,"lon":146},44.80401,20.46513,{"facility":148,"status":101,"city":149,"zip":150,"country":143,"geoPoint":151},"Sremska Kamenica","Kamenitz","21204",{"lat":152,"lon":153},45.22334,19.84263,{"facility":155,"status":101,"city":155,"zip":156,"country":143,"geoPoint":157},"Niš","18000",{"lat":158,"lon":159},43.32472,21.90333,{"facility":161,"status":101,"city":162,"zip":163,"country":164,"geoPoint":165},"Gyeonggi-Do","Gyeonggi-do","14353","South Korea",{"lat":166,"lon":167},37.58944,126.76917,{"facility":169,"status":101,"city":169,"zip":170,"country":164,"geoPoint":171},"Seoul","05505",{"lat":172,"lon":173},37.566,126.9784,{"facility":175,"status":101,"city":175,"zip":176,"country":177,"geoPoint":178},"Barcelona","08002","Spain",{"lat":179,"lon":180},41.38879,2.15899,{"facility":182,"status":101,"city":182,"zip":183,"country":177,"geoPoint":184},"Madrid","28046",{"lat":185,"lon":186},40.4165,-3.70256,{"facility":188,"status":101,"city":188,"zip":189,"country":177,"geoPoint":190},"Santander","39011",{"lat":191,"lon":192},43.46589,-3.80493,[194],{"name":195,"role":196,"phone":197,"email":198},"Clinical Trials","CONTACT","+1 339 337 4053","ClinicalTrials@tectonictx.com",[],[],[],{"nct_id":4,"conditions":203,"biomarkers":206},[204,205],"Interstitial Lung Disease","Pulmonary Hypertension",[],{"nct_id":4,"found":208,"summary":209,"prompt_version":219},true,{"design":210,"status":211,"heading":212,"summary":213,"follow_up":214,"word_count":215,"commitments":216,"compensation":217,"drugs_mentioned":218},"This is an interventional study with an estimated enrollment of 25 participants. The phase of the study is not specified.","completed","Study of TX000045 for Pulmonary Hypertension Due to Interstitial Lung Disease","This study is testing a drug called TX000045, given as an injection under the skin, for people with pulmonary hypertension (high blood pressure in the arteries of the lungs) caused by interstitial lung disease (ILD). Researchers want to see how well TX000045 affects pulmonary vascular resistance (PVR), which is a measure of how hard your heart has to work to pump blood through your lungs. They will also be looking closely at the safety and any side effects of TX000045. You might be able to join if you are between 18 and 80 years old and have a confirmed diagnosis of ILD with fibrosis. The study aims to enroll 25 participants, but its current recruitment status is unclear.","Safety will be monitored up to 21 weeks after the start of the study.",118,"Not specified in the trial record.","Not stated in the trial record.",[34],"v2"]