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An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)

NCT05649748

Active Not RecruitingPhase 2, Phase 3

Sponsor: Insmed Incorporated

Conditions: Pulmonary Arterial Hypertension

Interventions: Treprostinil Palmitil, Placebo

Countries: United States, Argentina, Austria, Belgium, Brazil, Denmark, Germany, Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Male and female participants who completed end of treatment study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study. Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit.
* Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study.

Exclusion Criteria:

* Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of studies INS1009-201, INS1009-202 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE \[Tyvaso\] or iloprost) and oral prostacyclin analogues (eg, TRE \[Orenitram\]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration.
* Any new ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any new symptomatic bradycardia.
* New-onset 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).
* New evidence of thromboembolic disease as assessed by ventilation/perfusion (VQ) scan, pulmonary angiography, or pulmonary computed tomography (CT) scan.
* Active and current symptomatic coronavirus disease 2019 (COVID-19) or previous severe disease and/or hospitalization due to COVID-19.
* Interval organ transplantation.
* New active liver disease or hepatic dysfunction.
* Interval malignancy with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
* Use of any investigational drug/device or participation in any investigational study within 30 days prior to screening, not including TPIP of the lead-in study.
* Current use of cigarettes (as defined by Centers for Disease Control and Prevention \[CDC\]) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime, who smokes either every day or some days.
* Participants who currently inhale marijuana (recreational or medical).

Note: Other inclusion/exclusion criteria may apply.
Locations (45)
  • Jacksonville, Florida, United States
  • Tampa, Florida, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • New York, New York, United States
  • Dallas, Texas, United States
  • Quilmes, Buenos Aires, Argentina
  • Rosario, Santa Fe Province, Argentina
  • San Miguel de Tucumán, Tucumán Province, Argentina
  • Córdoba, Argentina
  • Córdoba, Argentina
  • Linz, Upper Austria, Austria
  • Vienna, Austria
  • Brussels, Belgium
  • Belo Horizonte, Minas Gerais, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Blumenau, Santa Catarina, Brazil
  • Aarhus, Central Jutland, Denmark
  • Heidelberg, Baden-Wurttemberg, Germany
  • München, Bavaria, Germany
  • Lübeck, Schleswig-Holstein, Germany
  • Pavia, Lombardy, Italy
  • Monza, Italy
  • Palermo, Italy
  • Roma, Italy
  • Sapporo, Hokkaido, Japan
  • Sapporo, Hokkaido, Japan
  • Kurume-shi, Hukuoka, Japan
  • Tsukuba, Ibaraki, Japan
  • Okayama, Okayama-ken, Japan
  • + 15 more on CT.gov