Pulmonary Arterial HypertensionPhase 2/3NCT05649748
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
A Phase 2/3 study testing Treprostinil Palmitil in people with Pulmonary Arterial Hypertension, run by Insmed Incorporated at 45 sites in 15 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Treprostinil Palmitil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 45 sitesin 15 countries
- Study dates
- 7 Mar 2023to 31 Dec 2026
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
45 sites in 15 countries.
45 sites in 15 countries
United States6 sites
USA006
Chicago, Illinois, 60611
USA001
Chicago, Illinois, 60612
USA016
Dallas, Texas, 75246
USA005
Jacksonville, Florida, 32224
USA102
New York, New York, 10021
USA011
Tampa, Florida, 33606
Japan6 sites
JPN007
Kurume-shi, Hukuoka, 830-0011
JPN002
Okayama, Okayama-ken, 701-1192
JPN005
Sapporo, Hokkaido, 060-8543
JPN004
Sapporo, Hokkaido, 060-8648
JPN003
Suita-Shi, Osaka, 564-8565
JPN006
Tsukuba, Ibaraki, 305-9576
Argentina5 sites
ARG004
Córdoba, X5000DCE
ARG001
Córdoba, X5000FPQ
ARG009
Quilmes, Buenos Aires, B1878GEG
ARG006
Rosario, Santa Fe Province, S2013KDS
ARG007
San Miguel de Tucumán, Tucumán Province, T4000AXL
Italy4 sites
ITA005
Monza, 20900
ITA001
Palermo, 90127
ITA002
Pavia, Lombardy, 27100
ITA004
Roma, 00161
Mexico4 sites
MEX005
Lomas de Guevara, Jalisco, 44657
MEX003
Mexico City, 14080
MEX001
Monterrey, Nuevo León, 64718
MEX004
San Luis Potosí City, 78250
Brazil3 sites
BRA004
Belo Horizonte, Minas Gerais, 30430-142
BRA002
Blumenau, Santa Catarina, 89030-101
BRA006
Porto Alegre, Rio Grande do Sul, 90035-003
Germany3 sites
GER005
Heidelberg, Baden-Wurttemberg, 69126
GER002
Lübeck, Schleswig-Holstein, 23562
GER003
München, Bavaria, 80639
Malaysia3 sites
MYS005
Alor Star, Kedah, 5460
MYS002
Kuantan, Pahang, 25200
MYS004
Sungai Buloh, Selangor, 47000
Philippines2 sites
PHL002
Makati City, 1229
PHL001
Quezon City, National Capital Region, 1100
About this study
Official title: An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Treprostinil Palmitil, Placebo
- Keywords
- Treprostinil Palmitil
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treprostinil PalmitilDrug
Also called INS1009
Administered by oral inhalation, using a Plastiape capsule-based dry powder inhaler.
PlaceboDrug
Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| 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:
1. TPIP- will be given placebo QD(80 μg upto achieved TPIP dose from previous study)along with achieved TPIP dose from previous study in blinded manner during 3-week titration period.
2. Placebo- will be given TPIP QD (80 μg up to achieved placebo dose from previous study)along with achieved placebo dose from previous study in blinded manner during 3-week titration period.Overall treatment period=24 months. Receives: Drug: Treprostinil Palmitil; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience at Least one Treatment Emergent Adverse Event (TEAE) and TEAEs by Severity
Measured: From screening up to last follow up visit (Up to approximately 26 months)
Secondary outcomes (7)
Absolute Change From Pre-Open Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD)
Measured: Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24
Relative Change From Pre-OLE Baseline in 6MWD
Measured: Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in the Concentration of N-Terminal Fragment B-Type Natriuretic Peptide (NT-proBNP) in Blood
Measured: 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
Measured: 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
Measured: 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.
Measured: OLE Baseline (Day 1) up to Month 24 or early discontinuation
Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Measured: OLE Baseline (Day 1), Months 6, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start7 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Insmed Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649748
- Sponsor's protocol ID
- INS1009-203
- Other IDs
- 2022-001951-18, 2023-505539-11-00, 2023
- Status last verified
- Oct 2026
- First submitted
- 6 Dec 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available