Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
Study NCT ID:
NCT06635850
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2024-10-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Mosliciguat in PH-ILD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058995', 'term': 'Dry Powder Inhalers'}], 'ancestors': [{'id': 'D009330', 'term': 'Nebulizers and Vaporizers'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2024-10-08', 'studyFirstSubmitQcDate': '2024-10-08', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline to Week 16 in Pulmonary Vascular Resistance (PVR)', 'timeFrame': 'Baseline, Week 16', 'description': 'PVR evaluated using right heart catheterization (RHC).'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline to Week 16 in Distance Achieved on the Six-Minute Walk Test (6MWT)', 'timeFrame': 'Baseline, Week 16', 'description': 'The 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes.'}, {'measure': 'Change from Baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)', 'timeFrame': 'Baseline, Week 16', 'description': 'The NT-proBNP serum concentration 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 16.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['PH', 'ILD', '6 Minute Walk Test', 'mosliciguat'], 'conditions': ['Pulmonary Hypertension', 'Interstitial Lung Disease', 'Lung Diseases', 'Vascular Diseases', 'Cardiovascular Diseases', 'Fibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://phocusstudy.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical study to evaluate the safety and efficacy of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD).', 'detailedDescription': 'This study is a randomized, double-blind, placebo-controlled 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 will receive mosliciguat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants willing and able to provide informed consent\n* Participants with diagnosis of Interstitial Lung Disease (ILD). Diagnosis will be confirmed by a high-resolution computerized tomography (HR-CT) scan showing diffuse parenchymal disease. Eligible diagnosed diseases include:\n\n 1. Idiopathic interstitial pneumonia (IIP)\n 2. Chronic hypersensitivity pneumonitis\n 3. ILD associated with connective tissue disease (CTD) with a forced vital capacity (FVC) \\< 70% of predicted\n* Confirmed pulmonary hypertension (PH) by right heart catheterization (RHC).\n* Ability to perform 6MWD ≥100 meters.\n\nExclusion Criteria:\n\n* Diagnosis of PH Group 1 (eg. pulmonary arterial hypertension), Group 2 (related to left-heart dysfunction), Group 4 (eg, chronic thromboembolic pulmonary hypertension), or Group 5 (eg, unclassified).\n* Exacerbation of underlying lung disease within 28 days prior to randomization.\n* Initiation of pulmonary rehabilitation within 28 days prior to randomization.\n* Receiving \\>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.\n* History or intolerance to or lack of efficacy with mosliciguat or sGC stimulators or activators.\n* Receipt of investigational, or experimental therapy within 42 days OR 5 half-lives prior to randomization.\n\nNote: Other inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06635850', 'acronym': 'PHocus', 'briefTitle': 'A Study of Mosliciguat in PH-ILD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pulmovant, Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Placebo-Controlled Trial to Assess the Efficacy and Safety of Mosliciguat in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease', 'orgStudyIdInfo': {'id': 'RVT-2301-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mosliciguat', 'description': 'Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks', 'interventionNames': ['Drug: Mosliciguat', 'Device: Dry Powder Inhaler']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matched Placebo', 'description': 'Participants will be randomized to receive inhaled mosliciguat or placebo daily for 24 weeks', 'interventionNames': ['Device: Dry Powder Inhaler', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Extension', 'description': 'After Week 24, all participants may receive mosliciguat through an Extension period', 'interventionNames': ['Drug: Mosliciguat', 'Device: Dry Powder Inhaler']}], 'interventions': [{'name': 'Mosliciguat', 'type': 'DRUG', 'description': 'Dose level 1, 2, or 3 for inhalation', 'armGroupLabels': ['Extension', 'Mosliciguat']}, {'name': 'Dry Powder Inhaler', 'type': 'DEVICE', 'description': 'Dry powder inhaler for mosliciguat or placebo delivery', 'armGroupLabels': ['Extension', 'Matched Placebo', 'Mosliciguat']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo for inhalation', 'armGroupLabels': ['Matched Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Isaac Jackson', 'role': 'CONTACT', 'email': 'ijackson@azpulm.com'}], 'facility': 'Arizona Pulmonary Specialists', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jaclene Torres', 'role': 'CONTACT', 'email': 'jaclenetorres@mednet.ucla.edu', 'phone': '602-271-0832'}], 'facility': 'Ronald Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Occhipinti', 'role': 'CONTACT', 'email': 'mocchipinti@ucdavis.edu', 'phone': '916-734-4008'}], 'facility': 'University of California Davis School of Medicine', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dylan Huynh', 'role': 'CONTACT', 'email': 'dylan.huynh@lundquist.org', 'phone': '310-222-3560'}], 'facility': 'Harbor-UCLA Medical Center - Torrance', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '34746', 'city': 'Celebration', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lusmelys Guevara', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'lusmelys@floridalungdoctors.com'}], 'facility': 'Florida Lung, Asthma & Sleep Specialists/Clinical Research Specialists, LLC', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}, {'zip': '60026', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Grace O'Toole", 'role': 'CONTACT', 'email': 'grace.otoole@northwestern.edu', 'phone': '312-503-4545'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kimberly Schiltz', 'role': 'CONTACT', 'email': 'kimberly-schiltz@uiowa.edu', 'phone': '319-353-5225'}], 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Crystal Billings', 'role': 'CONTACT', 'email': 'cbillings4@kumc.edu', 'phone': '913-588-2817'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Robinson', 'role': 'CONTACT', 'email': 'kimberly.robinson@nortonhealthcare.org'}], 'facility': 'Norton Pulmonary Specialists', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Ptashnik', 'role': 'CONTACT', 'email': 'david.ptashnik@duke.edu'}], 'facility': 'Duke University Health System - Duke Clinic', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27403', 'city': 'Greensboro', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Murali Ramaswamy, MD', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'murali.ramaswamy@pulmonix.com', 'phone': '336-522-8870'}], 'facility': 'PulmonIx', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rhiannon Ditmar', 'role': 'CONTACT', 'email': 'ditmarrn@ucmail.uc.edu', 'phone': '513-584-2190'}], 'facility': 'Hoxworth Blood Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97701', 'city': 'Bend', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madison Cox', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'mklinskicox@summithealth.com'}], 'facility': 'Summit Health', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Selwood', 'role': 'CONTACT', 'email': 'kim.selwood@tuhs.temple.edu', 'phone': '215-707-1359'}], 'facility': 'Lewis Katz School of Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02915', 'city': 'East Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Sanders', 'role': 'CONTACT', 'email': 'rsanders1@brownhealth.org'}], 'facility': 'Brown Medicine', 'geoPoint': {'lat': 41.81371, 'lon': -71.37005}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Whitney Brako-Kusi', 'role': 'CONTACT', 'email': 'brakokus@musc.edu', 'phone': '843-792-1820'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Herpreet Sandhu', 'role': 'CONTACT', 'email': 'hsandhu@houstonmethodist.org'}], 'facility': 'Houston Methodist Lung Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132-0001', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashlynn Leavitt', 'role': 'CONTACT', 'email': 'ash.leavitt@hsc.utah.edu'}], 'facility': 'University of Utah Health', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Pulmovant', 'role': 'CONTACT', 'email': 'clinicaltrials@pulmovant.com', 'phone': '+1-919-462-1310'}], 'overallOfficials': [{'name': 'Ubaldo Martin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pulmovant, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pulmovant, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}