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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001951-18 | EudraCT Number | ||
| 2023-505539-11-00 | Other Identifier | EU CT Number |
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The primary purpose of the study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) and other lead-in studies of TPIP in participants with PAH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treprostinil Palmitil Inhalation Powder (TPIP) | Experimental | Participants who are not transitioning immediately from other TPIP studies:INS1009-201(NCT04791514), INS1009-202(NCT05147805) and other lead-in studies, will be given TPIP, once daily (QD), starting with 80 micrograms (μg), up-titrated to highest tolerated dose between 80 μg and 640 μg during 3-week titration period that maybe increased upto maximum dose of 1280 μg QD post initial titration, per investigator's assessment. Overall treatment period=24 months. Participants transitioning immediately from randomized blinded lead-in TPIP study and who previously received:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treprostinil Palmitil | Drug | Administered by oral inhalation, using a Plastiape capsule-based dry powder inhaler. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience at Least one Treatment Emergent Adverse Event (TEAE) and TEAEs by Severity | From screening up to last follow up visit (Up to approximately 26 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), Months 6, 12, 18, and 24 | |
| Relative Change From Pre-OLE Baseline in 6MWD | Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Insmed Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA005 | Jacksonville | Florida | 32224 | United States | ||
| USA011 |
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| Placebo | Drug | Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler |
|
| 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), Months 6, 12, 18, and 24 |
| Change From Pre-OLE Baseline in the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Score | Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24 |
| Change From Pre-OLE Baseline in New York Heart Association/ World Health Organization (NYHA/WHO) Functional Capacity Class | Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24 |
| Annualized Clinical Worsening Event Rate | 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. Clinical worsening events are one of the following: All-cause death, or onset of TEAE with a fatal outcome occurring ≤ 14 days after study drug discontinuation; Hospitalization for right heart failure (for > 48 hours), heart-lung or lung transplant, or atrial septostomy; Addition (or increase in dose) of specified PAH-specific medications; Combined occurrence of events including ≥20% decrease in 6MWD, worsening WHO/NYHA functional capacity class, and appearance of or worsening of signs/symptoms of right heart failure from baseline. | OLE Baseline (Day 1) up to Month 24 or early discontinuation |
| Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE) | OLE Baseline (Day 1), Months 6, 12, 18, and 24 |
| Tampa |
| Florida |
| 33606 |
| United States |
| USA006 | Chicago | Illinois | 60611 | United States |
| USA001 | Chicago | Illinois | 60612 | United States |
| USA102 | New York | New York | 10021 | United States |
| USA016 | Dallas | Texas | 75246 | United States |
| ARG009 | Quilmes | Buenos Aires | B1878GEG | Argentina |
| ARG006 | Rosario | Santa Fe Province | S2013KDS | Argentina |
| ARG007 | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| ARG004 | Córdoba | X5000DCE | Argentina |
| ARG001 | Córdoba | X5000FPQ | Argentina |
| AUT002 | Linz | Upper Austria | 4020 | Austria |
| AUT001 | Vienna | 1090 | Austria |
| BEL003 | Brussels | 1070 | Belgium |
| BRA004 | Belo Horizonte | Minas Gerais | 30430-142 | Brazil |
| BRA006 | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| BRA002 | Blumenau | Santa Catarina | 89030-101 | Brazil |
| DNK001 | Aarhus | Central Jutland | 8200 | Denmark |
| GER005 | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| GER003 | München | Bavaria | 80639 | Germany |
| GER002 | Lübeck | Schleswig-Holstein | 23562 | Germany |
| ITA002 | Pavia | Lombardy | 27100 | Italy |
| ITA005 | Monza | 20900 | Italy |
| ITA001 | Palermo | 90127 | Italy |
| ITA004 | Roma | 00161 | Italy |
| JPN005 | Sapporo | Hokkaido | 060-8543 | Japan |
| JPN004 | Sapporo | Hokkaido | 060-8648 | Japan |
| JPN007 | Kurume-shi | Hukuoka | 830-0011 | Japan |
| JPN006 | Tsukuba | Ibaraki | 305-9576 | Japan |
| JPN002 | Okayama | Okayama-ken | 701-1192 | Japan |
| JPN003 | Suita-Shi | Osaka | 564-8565 | Japan |
| MYS005 | Alor Star | Kedah | 5460 | Malaysia |
| MYS002 | Kuantan | Pahang | 25200 | Malaysia |
| MYS004 | Sungai Buloh | Selangor | 47000 | Malaysia |
| MEX005 | Lomas de Guevara | Jalisco | 44657 | Mexico |
| MEX001 | Monterrey | Nuevo León | 64718 | Mexico |
| MEX003 | Mexico City | 14080 | Mexico |
| MEX004 | San Luis Potosí City | 78250 | Mexico |
| PHL001 | Quezon City | National Capital Region | 1100 | Philippines |
| PHL002 | Makati City | 1229 | Philippines |
| SRB001 | Belgrade | 11000 | Serbia |
| SRB003 | Belgrade | 11000 | Serbia |
| ESP001 | Santander | 39008 | Spain |
| ESP003 | Seville | 41009 | Spain |
| GBR001 | Bath | Avon | BA1 3NG | United Kingdom |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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