Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-29 @ 8:17 AM
Study NCT ID:
NCT07234032
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (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'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 344}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'nctId': 'NCT06939647', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-01-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2031-01-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 108 weeks'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 6-Minute Walk Distance (6MWD) Measured Post-Dose', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Absolute Change From Baseline in Forced Vital Capacity (FVC)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Percent Change From Baseline in Forced Vital Capacity (FVC)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Absolute Change From Baseline in Percent Predicted FVC (FVC% pred)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Percent Change From Baseline in Percent Predicted FVC (FVC% pred)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Absolute Change From Baseline in Percent Predicted FEV1 (FEV1%)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Percent Change From Baseline in Percent Predicted FEV1 (FEV1%)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Change From Baseline in the Plasma Concentration of N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Annualized Rate of Occurrence of Exacerbations of Interstitial Lung Disease (ILD)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Percentage of Participants With a Clinical Worsening Events', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Domain Score', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Mean Change From Baseline in L-PF Cough Domain Score', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Mean Change From Baseline in L-PF Dyspnea Domain Score', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Mean Change From Baseline in L-PF Impact Domain Score', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Mean Change From Baseline in the EuroQoL- 5 Dimensions (EQ-5D-5L) Index Score', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Mean Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Percentage of Participants With Major Morbidity or Mortality Events', 'timeFrame': 'Up to 104 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary hypertension, interstitial lung disease'], 'conditions': ['Pulmonary Hypertension', 'Interstitial Lung Disease']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/or 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/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07234032', 'briefTitle': 'An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Insmed Incorporated'}, 'officialTitle': 'A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease', 'orgStudyIdInfo': {'id': 'INS1009-312'}, 'secondaryIdInfos': [{'id': '2025-521769-29-00', 'type': 'OTHER', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treprostinil Palmitil Inhalation Powder (TPIP)', 'description': '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.', 'interventionNames': ['Drug: Treprostinil Palmitil Inhalation Powder', 'Drug: Placebo']}], 'interventions': [{'name': 'Treprostinil Palmitil Inhalation Powder', 'type': 'DRUG', 'otherNames': ['INS1009'], 'description': 'Oral inhalation using a capsule-based dry powder.', 'armGroupLabels': ['Treprostinil Palmitil Inhalation Powder (TPIP)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral inhalation in initial double-dummy titration period.', 'armGroupLabels': ['Treprostinil Palmitil Inhalation Powder (TPIP)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Insmed Incorporated', 'role': 'CONTACT', 'email': 'medicalinformation@insmed.com', 'phone': '18444467633'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insmed Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}