Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT05176951
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2021-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['New Zealand', 'Puerto Rico', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'dispFirstSubmitDate': '2025-03-13', 'completionDateStruct': {'date': '2024-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2021-12-10', 'studyFirstSubmitQcDate': '2022-01-03', 'dispFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Day 140'}, {'measure': 'Number of Participants Who Experience Any Number of Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Day 140'}, {'measure': 'Change from Baseline in Saturation of Peripheral Capillary Oxygenation (SpO2) Levels', 'timeFrame': 'Pre-, during, and post- 6-minute walk test (6MWT) at Baseline, Week 5, Week 10, and Week 16'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of Treprostinil Palmitil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'Cmax of Treprostinil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of Treprostinil Palmitil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'Tmax of Treprostinil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'Area Under Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUCtau) of Treprostinil Palmitil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'AUCtau of Treprostinil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'Area Under Concentration-time Curve From 0 to Infinity (AUC∞) of Treprostinil Palmitil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'AUC∞ of Treprostinil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'Area Under Concentration-time Curve From Time 0 to Last Measurable Concentration (AUClast) of Treprostinil Palmitil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'AUClast of Treprostinil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'Apparent Total Clearance (CL/F) of Treprostinil Palmitil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'CL/F of Treprostinil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'Elimination Half-life (t1/2) of Treprostinil Palmitil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 't1/2 of Treprostinil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'Apparent Volume of Distribution After Terminal Phase (Vd/F) of Treprostinil Palmitil', 'timeFrame': 'Day 1 to Week 16'}, {'measure': 'Vd/F of Treprostinil', 'timeFrame': 'Day 1 to Week 16'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'Interstitial Lung Disease', 'Treprostinil Palmitil'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females must be ≥ 18 to ≤ 80 years of age at the time of signing the informed consent form (ICF).\n* Diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD) (including idiopathic interstitial pneumonia \\[IIP\\], idiopathic pulmonary fibrosis \\[IPF\\], connective tissue disease \\[CTD\\], sarcoidosis).\n* Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Male participants:\n\nMale participants who are not sterile, with female partners of childbearing potential, must be using effective contraception from Day 1 to at least 90 days after the last dose of study drug.\n\nMale participants with women of child bearing potential (WOCBP) partner must use a condom in order to avoid potential exposure to embryo/fetus.\n\n\\- Female participants: Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, (ie,hysterectomy and/or bilateral salpingo-oophorectomy) or using highly effective contraception methods (ie, methods that alone or in combination achieve \\<1% unintended pregnancy rates per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose of study drug.\n\n\\- Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\n* Primary diagnosis of chronic obstructive pulmonary disease (COPD).\n* Allergy, or documented hypersensitivity or contraindication to TPIP or treprostinil (TRE) or mannitol (an excipient of the TPIP formulation).\n* Received or currently treated with riociguat, endothelin receptor antagonists, selexipag, phosphodiesterase 5 (PDE5) inhibitors and/or prostacyclin analogues within 30 days prior to Screening.\n* Started therapy with pirfenidone or nintedanib \\< 90 days prior to Screening, OR, if already receiving either medication, there is a dose change within 30 days of Screening Visit.\n* Any known ventricular or supraventricular tachyarrhythmia (except for paroxysmal atrial fibrillation), and/or any symptomatic bradycardia.\n* History of heart disease including left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc).\n* Participation in a cardiopulmonary rehabilitation program within 30 days of the first Screening Visit. Participation in the maintenance program of a cardiopulmonary rehabilitation program is allowed.\n* Acutely decompensated heart failure within 30 days of Screening Visit.\n* Active and current symptomatic coronavirus disease 2019 (COVID-19) and/or previous diagnosis of moderate to severe disease, or hospitalization due to COVID-19.\n* Supplemental oxygen requirement \\> 10L/min at rest at Screening.\n* Exacerbation of underlying lung disease or active pulmonary or upper respiratory infection within 30 days of the first dose of study drug (may be rescreened at appropriate time).\n* Current or recent (past 30 days) lower respiratory tract infection (may be rescreened at appropriate time).\n* Any form of congenital heart disease or congenital heart defect (repaired or unrepaired) other than a patent foramen ovale.\n* History of alcohol or drug abuse within 6 months prior to Screening.\n* Current use of cigarettes (as defined by Center for Disease Control (CDC)) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days.\n* Participants who currently inhale marijuana (recreational or medical).\n* Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6-minute walk test (6MWT) (eg, angina pectoris, claudication, musculoskeletal disorder, need for walking aids).'}, 'identificationModule': {'nctId': 'NCT05176951', 'briefTitle': 'A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Insmed Incorporated'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease', 'orgStudyIdInfo': {'id': 'INS1009-211'}, 'secondaryIdInfos': [{'id': '2021-003294-66', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treprostinil Palmitil', 'description': 'Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be titrated up to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks.', 'interventionNames': ['Drug: Treprostinil Palmitil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be administered a placebo matching TPIP once daily.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Treprostinil Palmitil', 'type': 'DRUG', 'otherNames': ['INS1009'], 'description': 'Oral inhalation using a capsule-based dry powder inhaler device.', 'armGroupLabels': ['Treprostinil Palmitil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral inhalation using a capsule-based dry powder inhaler device.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1280AEB', 'city': 'Barracas', 'state': 'Ciudad Autónoma de BuenosAires', 'country': 'Argentina', 'facility': 'ARG003', 'geoPoint': {'lat': -34.64966, 'lon': -58.38341}}, {'zip': 'S2013KDS', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'ARG001', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'CI094AAD', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'ARG008', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'AUS003', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2109', 'city': 'Macquarie Park', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'AUS005', 'geoPoint': {'lat': -33.78105, 'lon': 151.12757}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'BEL002', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '69126', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GER006', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '35392', 'city': 'Giessen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'GER010', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '45239', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'GER003', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GER001', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GER002', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GER012', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'GER004', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'facility': 'ITA003', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '20123', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'ITA004', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20900', 'city': 'Monza', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'ITA002', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '90127', 'city': 'Palermo', 'state': 'Sicily', 'country': 'Italy', 'facility': 'ITA001', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '07120', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'ESP003', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'ESP007', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'ESP010', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'ESP005', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '35010', 'city': 'Las Palmas de Gran Canaria', 'country': 'Spain', 'facility': 'ESP006', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'ESP009', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': 'G81 4HX', 'city': 'Glasgow', 'state': 'Lanarkshire', 'country': 'United Kingdom', 'facility': 'GBR003', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'S10 2JF', 'city': 'Sheffield', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'GBR001', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insmed Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}