An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
Running, not enrolling · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Pulmonary Arterial Hypertension
In brief
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.
Key facts
- Study ID
- NCT05649748
- Run by
- Insmed Incorporated
- People needed
- 91
- Starts
- 2023-03-07
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- USA005 — Jacksonville, Florida, United States
- USA011 — Tampa, Florida, United States
- USA006 — Chicago, Illinois, United States
- USA001 — Chicago, Illinois, United States
- USA102 — New York, New York, United States
- USA016 — Dallas, Texas, United States
- ARG009 — Quilmes, Buenos Aires, Argentina
- ARG006 — Rosario, Santa Fe Province, Argentina
- ARG007 — San Miguel de Tucumán, Tucumán Province, Argentina
- ARG004 — Córdoba, Argentina
- ARG001 — Córdoba, Argentina
- AUT002 — Linz, Upper Austria, Austria
- AUT001 — Vienna, Austria
- BEL003 — Brussels, Belgium
- BRA004 — Belo Horizonte, Minas Gerais, Brazil
- BRA006 — Porto Alegre, Rio Grande do Sul, Brazil
- BRA002 — Blumenau, Santa Catarina, Brazil
- DNK001 — Aarhus, Central Jutland, Denmark
- GER005 — Heidelberg, Baden-Wurttemberg, Germany
- GER003 — München, Bavaria, Germany
- GER002 — Lübeck, Schleswig-Holstein, Germany
- ITA002 — Pavia, Lombardy, Italy
- ITA005 — Monza, Italy
- ITA001 — Palermo, Italy
- ITA004 — Roma, Italy
Full record on ClinicalTrials.gov
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