[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655717":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":39,"studyPopulation":27,"armGroups":40,"interventions":58,"overallOfficials":72,"centralContacts":76,"locations":82,"responsibleParty":122,"collaborators":27,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":27,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":27,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":147,"overallStatus":85,"whyStopped":27,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Pulmovant, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in 6-Minute Walk Distance (6MWD)","The 6MWD measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes","Baseline to Week 24",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Time to Clinical Worsening (TTCW)","Time from randomization to first occurrence of any of the following events as adjudicated by the independent Event Adjudication Committee (EAC).\n\n1. Hospitalization \\>24 hours due to a cardiopulmonary indication\n2. Decrease in 6MWD \\>15% from baseline directly related to PH-ILD, at two consecutive visits on a different day but no more than 7 days apart\n3. Death (all causes)\n4. Lung transplantation for worsening PH (except when pre-planned prior to the trial)\n5. Need to initiate additional therapeutic intervention for the treatment of PH","From randomization through Week 24",{"measure":19,"description":20,"timeFrame":12},"Percent Change from Baseline in Pulmonary Vascular Resistance (PVR)","PVR evaluated using right heart catheterization (RHC)",{"measure":22,"description":23,"timeFrame":12},"Change from Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)","The NT-ProBNP serum concentrations is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at Baseline and Week 24.",{"measure":25,"description":26,"timeFrame":12},"Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Total Symptom Score","Change from baseline to Week 24 in L-PF total symptom scores (patient-reported outcome).",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":34},"QUADRUPLE",[35,36,37,38],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This study is a randomized double-blind placebo control study with an extension.\n\nThe study consists of 2 periods: a blinded placebo-controlled period (24 weeks) and an extension (beyond 24 weeks).\n\nParticipants will be randomized to receive mosliciguat or placebo in the 24-week double-blind treatment period.\n\nAll participants who complete the 24-week double-blind period may continue to participate in the extension period where all participants receive mosliciguat.",[41,48,53],{"label":42,"type":43,"description":44,"interventionNames":45},"Mosliciguat","ACTIVE_COMPARATOR","Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks",[46,47],"Drug: Mosliciguat","Device: Dry Powder Inhaler",{"label":49,"type":50,"description":44,"interventionNames":51},"Matched Placebo","PLACEBO_COMPARATOR",[52,47],"Drug: Placebo",{"label":54,"type":55,"description":56,"interventionNames":57},"Extension","EXPERIMENTAL","After Week 24, all participants may receive mosliciguat through an Extension period",[46,47],[59,63,67],{"type":60,"name":42,"description":61,"armGroupLabels":62,"otherNames":27},"DRUG","Dose level 1, 2, or 3 for inhalation",[54,42],{"type":60,"name":64,"description":65,"armGroupLabels":66,"otherNames":27},"Placebo","Matching Placebo for inhalation",[49],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":27},"DEVICE","Dry Powder Inhaler","Administration via dry powder inhaler",[54,49,42],[73],{"name":74,"affiliation":5,"role":75},"Ubaldo Martin","STUDY_DIRECTOR",[77],{"name":78,"role":79,"phone":80,"phoneExt":27,"email":81},"Pulmovant Inc","CONTACT","+1-919-462-1310","clinicaltrials@pulmovant.com",[83,100,111],{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Clinical Research Site","RECRUITING","Kissimmee","Florida","34746","United States","US",{"type":92,"coordinates":93},"Point",[94,95],-81.41667,28.30468,{"lat":95,"lon":94},[98],{"name":99,"role":79,"phone":27,"phoneExt":27,"email":27},"Clinical Site",{"facility":84,"status":85,"city":101,"state":102,"zip":103,"country":89,"countryCode":90,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Louisville","Kentucky","40202",{"type":92,"coordinates":105},[106,107],-85.75941,38.25424,{"lat":107,"lon":106},[110],{"name":99,"role":79,"phone":27,"phoneExt":27,"email":27},{"facility":84,"status":85,"city":112,"state":113,"zip":114,"country":89,"countryCode":90,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Bend","Oregon","97701",{"type":92,"coordinates":116},[117,118],-121.31531,44.05817,{"lat":118,"lon":117},[121],{"name":99,"role":79,"phone":27,"phoneExt":27,"email":27},{"type":123,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100655717","phase-3-a-phase-3-trial-of-inhaled-mosliciguat-in-ph-ild-phrontier-100655717",false,"NCT07816185","A Phase 3 Trial of Inhaled Mosliciguat in PH-ILD (PHrontier)","A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease","Inclusion Criteria:\n\n* Participants willing and able to provide informed consent.\n* Participants with diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed disease include:\n\n  1. Idiopathic interstitial pneumonia (IIP)\n  2. Chronic Hypersensitivity pneumonitis\n  3. ILD associated connective tissue disease (CTD)\n* Confirmed pulmonary hypertension by right heart catheterization (RHC).\n* Ability to perform 6-minute walk distance ≥100 meters.\n\nExclusion Criteria:\n\n* Diagnosis of PH Group 1 (eg, pulmonary arterial hypertension), Group 2 (related to left heart disease), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).\n* Exacerbation of underlying lung disease requiring change in therapy or hospitalization within 28 days prior to randomization\n* Receiving \\>10 L\u002Fmin oxygen supplementation by any mode of delivery at rest\n* History of intolerance to mosliciguat, or sGC stimulators or activators.\n* Initiation of pulmonary rehabilitation or ongoing acute phase of rehabilitation within 28 days prior to randomization.\n* Receipt of investigational or interventional therapy within 42 days OR 5 half-lives (whichever is longer) prior to randomization.","ALL","18 Years","85 Years",{"count":135,"type":136},376,"ESTIMATED","INTERVENTIONAL",[139],"PHASE3","A Phase 3, Multicenter, Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Mosliciguat in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease",[142,143,144,145,146],"Pulmonary Hypertension","Interstitial Lung Disease","Vascular Diseases","Cardiovascular Diseases","Fibrosis",[148,149,150,151],"PH","ILD","6 Minute Walk Distance","mosliciguat","2026-09-07",{"date":154,"type":155},"2026-09-11","ACTUAL",{"date":157,"type":155},"2026-08-31",{"date":159,"type":136},"2029-08-31",{"name":5,"class":6},3]