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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521769-29-00 | Other Identifier | EU CT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treprostinil Palmitil Inhalation Powder (TPIP) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treprostinil Palmitil Inhalation Powder | Drug | Oral inhalation using a capsule-based dry powder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs) | Up to 108 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 6-Minute Walk Distance (6MWD) Measured Post-Dose | Up to 104 weeks | |
| Absolute Change From Baseline in Forced Vital Capacity (FVC) | Up to 104 weeks | |
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Inclusion Criteria
Exclusion Criteria
Note: Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Insmed Incorporated | Contact | 18444467633 | medicalinformation@insmed.com |
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| Placebo | Drug | Oral inhalation in initial double-dummy titration period. |
|
| Percent Change From Baseline in Forced Vital Capacity (FVC) |
| Up to 104 weeks |
| Absolute Change From Baseline in Percent Predicted FVC (FVC% pred) | Up to 104 weeks |
| Percent Change From Baseline in Percent Predicted FVC (FVC% pred) | Up to 104 weeks |
| Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Up to 104 weeks |
| Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Up to 104 weeks |
| Absolute Change From Baseline in Percent Predicted FEV1 (FEV1%) | Up to 104 weeks |
| Percent Change From Baseline in Percent Predicted FEV1 (FEV1%) | Up to 104 weeks |
| Change From Baseline in the Plasma Concentration of N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) | Up to 104 weeks |
| Annualized Rate of Occurrence of Exacerbations of Interstitial Lung Disease (ILD) | Up to 104 weeks |
| Percentage of Participants With a Clinical Worsening Events | Up to 104 weeks |
| Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Domain Score | Up to 104 weeks |
| Mean Change From Baseline in L-PF Cough Domain Score | Up to 104 weeks |
| Mean Change From Baseline in L-PF Dyspnea Domain Score | Up to 104 weeks |
| Mean Change From Baseline in L-PF Impact Domain Score | Up to 104 weeks |
| Mean Change From Baseline in the EuroQoL- 5 Dimensions (EQ-5D-5L) Index Score | Up to 104 weeks |
| Mean Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) | Up to 104 weeks |
| Percentage of Participants With Major Morbidity or Mortality Events | Up to 104 weeks |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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