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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001950-45 | EudraCT Number | ||
| 2023-505540-19-00 | 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 INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treprostinil Palmitil Inhalation Powder | Experimental | Participants who are not transitioning immediately from INS1009-211 and other lead-in studies, will be administered TPIP, once daily (QD), during 3-week titration period. Participants who are transitioning immediately from a randomized blinded lead-in TPIP study and who previously received:
The overall treatment period will be 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treprostinil Palmitil Inhalation Powder | Drug | Oral inhalation using a capsule-based dry powder inhaler device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE) | Up to approximately 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Pre-Open-Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD) | Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24 | |
| Relative Change From Pre-OLE Baseline in 6-MWD | Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24 |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or breastfeeding. Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug.
- Any medical or psychological condition, including relevant laboratory abnormalities at screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease that may present an unreasonable risk to the study participant as a result of participation in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARG003 | Autonomus City of Buenos Aires | Buenos Aires | C1280AEB | Argentina | ||
| ARG001 |
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| Placebo | Drug | Oral placebo inhalation using a capsule-based dry powder inhaler device. |
|
| Change From Pre-OLE Baseline in Forced Vital Capacity (FVC) | Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24 |
| Change From Pre-OLE Baseline in Percent Predicted FVC (FVC%) | Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24 |
| Change From Pre-OLE Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24 |
| Change From Pre-OLE Baseline in Percent Predicted FEV1 (FEV1%) | Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24 |
| Change From Pre-OLE Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75%) | Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24 |
| Absolute Change From Pre-OLE Baseline in Lung Diffusion Capacity for Carbon Monoxide (DLCO) | Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24 |
| Relative Change From Pre-OLE Baseline in Lung DLCO | Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24 |
| Change From Pre-OLE Baseline in the Concentration of N-Terminal Fragment B-Type Natriuretic Peptide (NT-proBNP) in Blood | Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24 |
| Annualized Rate of Clinical Worsening Events Based on Percentage of Participants With Clinical Worsening Events | Clinical worsening events are defined as one of the following: Hospitalization due to a cardiopulmonary indication; Lung transplantation; Death from any cause; Decrease in 6MWD ≥ 15% from baseline; Directly related to disease under study, at 2 consecutive visits at least 24 hours apart; Need for additional pulmonary hypertension (PH) therapy. Annualized clinical worsening event rate is defined as the total number of clinical worsening events that occurred during the treatment period divided by the total number of participant-years during the treatment period. | Up to Month 24 |
| Annualized Rate of Occurrence of Acute Exacerbations of Underlying Interstitial Lung Disease (AE-ILDs) | Up to Month 24 |
| Change From OLE Baseline in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Score | OLE Baseline (Day 1) to Months 6, 12, 18, and 24 |
| Change From OLE Baseline in the Euro Quality of Life-5 Dimension-5 Level (EQ-5D-5L) Questionnaire Score | OLE Baseline (Day 1) to Months 6, 12, 18, and 24 |
| Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE) | OLE Baseline (Day 1), Months 6, 12, 18, and 24 |
| Rosario |
| Santa Fe Province |
| S2013KDS |
| Argentina |
| AUS005 | Macquarie Park | New South Wales | 2109 | Australia |
| BEL002 | Liège | 4000 | Belgium |
| GER006 | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| GER004 | München | Bavaria | 81377 | Germany |
| GER010 | Giessen | Hesse | 35392 | Germany |
| GER003 | Essen | North Rhine-Westphalia | 45239 | Germany |
| GER001 | Dresden | Saxony | 01307 | Germany |
| GER002 | Berlin | 13125 | Germany |
| GER012 | Berlin | 14050 | Germany |
| ITA004 | Milan | Lombardy | 20123 | Italy |
| ITA002 | Monza | Lombardy | 20900 | Italy |
| ITA001 | Palermo | Sicily | 90127 | Italy |
| ITA003 | Naples | 80131 | Italy |
| ESP003 | Palma | Balearic Islands | 07120 | Spain |
| ESP009 | Santiago de Compostela | Galicia | 15706 | Spain |
| ESP007 | Oviedo | Principality of Asturias | 33011 | Spain |
| ESP005 | Barcelona | 08907 | Spain |
| ESP010 | Barcelona | 8035 | Spain |
| GBR003 | Clydebank | Glasgow | G81 4DY | United Kingdom |
| GBR001 | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
| 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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