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

NCT05649748 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: INS1009-2032022-001951-182023-505539-11-00
• Study Type: interventional
• Target: 91
• Locations: 15 countries
• Sites: 45

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Treprostinil Palmitil

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• 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

• 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

Study Arms (1)

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.

Drug: Treprostinil Palmitil; Drug: Placebo

Interventions

Placebo DRUG

Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler

Treprostinil Palmitil Inhalation Powder (TPIP)

Treprostinil Palmitil DRUG

Administered by oral inhalation, using a Plastiape capsule-based dry powder inhaler.

Also known as: INS1009

Treprostinil Palmitil Inhalation Powder (TPIP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (45)

USA005

Jacksonville, Florida, 32224, United States

Location

USA011

Tampa, Florida, 33606, United States

Location

USA006

Chicago, Illinois, 60611, United States

Location

USA001

Chicago, Illinois, 60612, United States

Location

USA102

New York, New York, 10021, United States

Location

USA016

Dallas, Texas, 75246, United States

Location

ARG009

Quilmes, Buenos Aires, B1878GEG, Argentina

Location

ARG006

Rosario, Santa Fe Province, S2013KDS, Argentina

Location

ARG007

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

ARG004

Córdoba, X5000DCE, Argentina

Location

ARG001

Córdoba, X5000FPQ, Argentina

Location

AUT002

Linz, Upper Austria, 4020, Austria

Location

AUT001

Vienna, 1090, Austria

Location

BEL003

Brussels, 1070, Belgium

Location

BRA004

Belo Horizonte, Minas Gerais, 30430-142, Brazil

Location

BRA006

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

BRA002

Blumenau, Santa Catarina, 89030-101, Brazil

Location

DNK001

Aarhus, Central Jutland, 8200, Denmark

Location

GER005

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

GER003

München, Bavaria, 80639, Germany

Location

GER002

Lübeck, Schleswig-Holstein, 23562, Germany

Location

ITA002

Pavia, Lombardy, 27100, Italy

Location

ITA005

Monza, 20900, Italy

Location

ITA001

Palermo, 90127, Italy

Location

ITA004

Roma, 00161, Italy

Location

JPN005

Sapporo, Hokkaido, 060-8543, Japan

Location

JPN004

Sapporo, Hokkaido, 060-8648, Japan

Location

JPN007

Kurume-shi, Hukuoka, 830-0011, Japan

Location

JPN006

Tsukuba, Ibaraki, 305-9576, Japan

Location

JPN002

Okayama, Okayama-ken, 701-1192, Japan

Location

JPN003

Suita-Shi, Osaka, 564-8565, Japan

Location

MYS005

Alor Star, Kedah, 5460, Malaysia

Location

MYS002

Kuantan, Pahang, 25200, Malaysia

Location

MYS004

Sungai Buloh, Selangor, 47000, Malaysia

Location

MEX005

Lomas de Guevara, Jalisco, 44657, Mexico

Location

MEX001

Monterrey, Nuevo León, 64718, Mexico

Location

MEX003

Mexico City, 14080, Mexico

Location

MEX004

San Luis Potosí City, 78250, Mexico

Location

PHL001

Quezon City, National Capital Region, 1100, Philippines

Location

PHL002

Makati City, 1229, Philippines

Location

SRB001

Belgrade, 11000, Serbia

Location

SRB003

Belgrade, 11000, Serbia

Location

ESP001

Santander, 39008, Spain

Location

ESP003

Seville, 41009, Spain

Location

GBR001

Bath, Avon, BA1 3NG, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: March 7, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); JP (6); DE (3); BE (1); PH (2); BR (3); SE (2); ES (2); ME (4); US (6); AR (5); DK (1); MY (3); IT (4); AU (2)