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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05649748
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Insmed Incorporated
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Austria, Brazil, Denmark, Germany, Italy, Japan, Malaysia, Mexico, Philippines, Serbia, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Arms & Interventions

Arms

Experimental: Treprostinil Palmitil Inhalation Powder (TPIP)

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: 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. 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.

Interventions

Drug: - Treprostinil Palmitil

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

Drug: - Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

USA006, Chicago, Illinois

Status

Recruiting

Address

USA006

Chicago, Illinois, 60611

USA001, Chicago, Illinois

Status

Recruiting

Address

USA001

Chicago, Illinois, 60612

USA102, New York, New York

Status

Recruiting

Address

USA102

New York, New York, 10021

USA016, Dallas, Texas

Status

Recruiting

Address

USA016

Dallas, Texas, 75246

International Sites

ARG009, Quilmes, Buenos Aires, Argentina

Status

Recruiting

Address

ARG009

Quilmes, Buenos Aires, B1878GEG

ARG006, Rosario, Santa Fe, Argentina

Status

Recruiting

Address

ARG006

Rosario, Santa Fe, S2013KDS

ARG007, San Miguel de Tucuman, Tucuman, Argentina

Status

Recruiting

Address

ARG007

San Miguel de Tucuman, Tucuman, T4000AXL

ARG004, Córdoba, Argentina

Status

Recruiting

Address

ARG004

Córdoba, , X5000DCE

ARG001, Córdoba, Argentina

Status

Recruiting

Address

ARG001

Córdoba, , X5000FPQ

AUT002, Linz, Oberösterreich, Austria

Status

Not yet recruiting

Address

AUT002

Linz, Oberösterreich, 4020

AUT001, Wien, Austria

Status

Not yet recruiting

Address

AUT001

Wien, , 1090

BRA004, Belo Horizonte, Minas Gerais, Brazil

Status

Recruiting

Address

BRA004

Belo Horizonte, Minas Gerais, 30430-142

BRA006, Porto Alegre, Rio Grande Do Sul, Brazil

Status

Recruiting

Address

BRA006

Porto Alegre, Rio Grande Do Sul, 90035-003

DNK001, Aarhus, Central Jutland, Denmark

Status

Not yet recruiting

Address

DNK001

Aarhus, Central Jutland, 8200

GER005, Heidelberg, Baden-Württemberg, Germany

Status

Recruiting

Address

GER005

Heidelberg, Baden-Württemberg, 69126

GER002, Lübeck, Schleswig-Holstein, Germany

Status

Recruiting

Address

GER002

Lübeck, Schleswig-Holstein, 23562

ITA002, Pavia, Lombardia, Italy

Status

Recruiting

Address

ITA002

Pavia, Lombardia, 27100

ITA005, Monza, Italy

Status

Recruiting

Address

ITA005

Monza, , 20900

JPN005, Sapporo-shi, Hokkaido, Japan

Status

Recruiting

Address

JPN005

Sapporo-shi, Hokkaido, 060-8543

JPN002, Okayama-Shi, Okayama, Japan

Status

Recruiting

Address

JPN002

Okayama-Shi, Okayama, 701-1192

JPN003, Suita-Shi, Osaka, Japan

Status

Recruiting

Address

JPN003

Suita-Shi, Osaka, 564-8565

MYS005, Alor Setar, Kedah, Malaysia

Status

Recruiting

Address

MYS005

Alor Setar, Kedah, 5460

MYS002, Kuantan, Pahang, Malaysia

Status

Recruiting

Address

MYS002

Kuantan, Pahang, 25200

MYS004, Sungai Buloh, Selangor, Malaysia

Status

Recruiting

Address

MYS004

Sungai Buloh, Selangor, 47000

MEX001, Monterrey, Nuevo León, Mexico

Status

Recruiting

Address

MEX001

Monterrey, Nuevo León, 64718

MEX004, San Luis Potosi, Mexico

Status

Recruiting

Address

MEX004

San Luis Potosi, , 78250

PHL002, Makati City, Philippines

Status

Recruiting

Address

PHL002

Makati City, , 1229

SRB003, Belgrade, Serbia

Status

Recruiting

Address

SRB003

Belgrade, , 11000

ESP001, Santander, Spain

Status

Recruiting

Address

ESP001

Santander, , 39008

ESP003, Sevilla, Spain

Status

Recruiting

Address

ESP003

Sevilla, , 41009

GBR001, Bath, Avon, United Kingdom

Status

Recruiting

Address

GBR001

Bath, Avon, BA1 3NG

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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