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A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

Study Purpose

The primary objective of this study is to evaluate the safety and tolerability of treprostinil palmitil inhalation powder (TPIP) compared with placebo

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 - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Males and females must be ≥ 18 to ≤ 80 years of age at the time of signing the informed consent form (ICF).
  • - Diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD) (including idiopathic interstitial pneumonia [IIP], idiopathic pulmonary fibrosis [IPF], connective tissue disease [CTD], sarcoidosis).
  • - Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • - Male participants: Male participants who are not sterile, with female partners of childbearing potential, must be using effective contraception from Day 1 to at least 90 days after the last dose of study drug.
Male participants with women of child bearing potential (WOCBP) partner must use a condom in order to avoid potential exposure to embryo/fetus.
  • - Female participants: Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, (ie,hysterectomy and/or bilateral salpingo-oophorectomy) or using highly effective contraception methods (ie, methods that alone or in combination achieve <1% unintended pregnancy rates per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose of study drug.
  • - Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

  • - Primary diagnosis of chronic obstructive pulmonary disease (COPD).
  • - Allergy, or documented hypersensitivity or contraindication to TPIP or treprostinil (TRE) or mannitol (an excipient of the TPIP formulation).
  • - Received or currently treated with riociguat, endothelin receptor antagonists, selexipag, phosphodiesterase 5 (PDE5) inhibitors and/or prostacyclin analogues within 30 days prior to Screening.
  • - Started therapy with pirfenidone or nintedanib < 90 days prior to Screening, OR, if already receiving either medication, there is a dose change within 30 days of Screening Visit.
  • - Any known ventricular or supraventricular tachyarrhythmia (except for paroxysmal atrial fibrillation), and/or any symptomatic bradycardia.
  • - History 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).
  • - Participation in a cardiopulmonary rehabilitation program within 30 days of the first Screening Visit.
Participation in the maintenance program of a cardiopulmonary rehabilitation program is allowed.
  • - Acutely decompensated heart failure within 30 days of Screening Visit.
  • - Active and current symptomatic coronavirus disease 2019 (COVID-19) and/or previous diagnosis of moderate to severe disease, or hospitalization due to COVID-19.
  • - Supplemental oxygen requirement > 10L/min at rest at Screening.
  • - Exacerbation of underlying lung disease or active pulmonary or upper respiratory infection within 30 days of the first dose of study drug (may be rescreened at appropriate time).
  • - Current or recent (past 30 days) lower respiratory tract infection (may be rescreened at appropriate time).
  • - Any form of congenital heart disease or congenital heart defect (repaired or unrepaired) other than a patent foramen ovale.
  • - History of alcohol or drug abuse within 6 months prior to Screening.
  • - Current use of cigarettes (as defined by Center for Disease Control (CDC)) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days.
  • - Participants who currently inhale marijuana (recreational or medical).
  • - Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6-minute walk test (6MWT) (eg, angina pectoris, claudication, musculoskeletal disorder, need for walking aids).

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.

NCT05176951
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
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 Active, not recruiting
Countries Argentina, Australia, Belgium, Germany, Italy, New Zealand, Puerto Rico, Spain, United Kingdom, United States
Conditions

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

Pulmonary Hypertension
Arms & Interventions

Arms

Experimental: Treprostinil Palmitil

Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be titrated up to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks.

Placebo Comparator: Placebo

Participants will be administered a placebo matching TPIP once daily.

Interventions

Drug: - Treprostinil Palmitil

Oral inhalation using a capsule-based dry powder inhaler device.

Drug: - Placebo

Oral inhalation using a capsule-based dry powder inhaler device.

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.

USA007, Los Angeles, California

Status

Address

USA007

Los Angeles, California, 90033-5313

USA008, Aurora, Colorado

Status

Address

USA008

Aurora, Colorado, 80045-2541

USA010, Altamonte Springs, Florida

Status

Address

USA010

Altamonte Springs, Florida, 32701-4817

USA017, Tampa, Florida

Status

Address

USA017

Tampa, Florida, 33606

USA002, Atlanta, Georgia

Status

Address

USA002

Atlanta, Georgia, 30309-1281

USA013, Indianapolis, Indiana

Status

Address

USA013

Indianapolis, Indiana, 46260-1992

USA003, Kansas City, Kansas

Status

Address

USA003

Kansas City, Kansas, 66160-8500

USA015, Boston, Massachusetts

Status

Address

USA015

Boston, Massachusetts, 02111-1552

USA006, Springfield, Massachusetts

Status

Address

USA006

Springfield, Massachusetts, 01101

USA001, Houston, Texas

Status

Address

USA001

Houston, Texas, 77070

USA004, McKinney, Texas

Status

Address

USA004

McKinney, Texas, 75069-8085

International Sites

ARG006, Villa Vatteone, Buenos Aires, Argentina

Status

Address

ARG006

Villa Vatteone, Buenos Aires, B1853AIK

ARG003, Barracas, Ciudad Autónoma De BuenosAires, Argentina

Status

Address

ARG003

Barracas, Ciudad Autónoma De BuenosAires, C1280AEB

ARG007, Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina

Status

Address

ARG007

Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, C1425BNG

ARG004, Villa Regina, Río Negro, Argentina

Status

Address

ARG004

Villa Regina, Río Negro, R8336

ARG001, Rosario, Santa Fe, Argentina

Status

Address

ARG001

Rosario, Santa Fe, S2002KDS

ARG002, San Miguel De Tucumán, Tucumán, Argentina

Status

Address

ARG002

San Miguel De Tucumán, Tucumán, T4000AXL

ARG008, Buenos Aires, Argentina

Status

Address

ARG008

Buenos Aires, , CI094AAD

AUS003, Camperdown, New South Wales, Australia

Status

Address

AUS003

Camperdown, New South Wales, 2050

AUS005, Macquarie Park, New South Wales, Australia

Status

Address

AUS005

Macquarie Park, New South Wales, 2109

AUS001, Westmead, New South Wales, Australia

Status

Address

AUS001

Westmead, New South Wales, 2145

AUS004, South Brisbane, Queensland, Australia

Status

Address

AUS004

South Brisbane, Queensland, 4101

BEL001, Anderlecht, Brussels, Belgium

Status

Address

BEL001

Anderlecht, Brussels, 1070

BEL003, Leuven, Vlaams Brabant, Belgium

Status

Address

BEL003

Leuven, Vlaams Brabant, 3000

BEL002, Liège, Belgium

Status

Address

BEL002

Liège, , 4000

GER006, Heidelberg, Baden-Württemberg, Germany

Status

Address

GER006

Heidelberg, Baden-Württemberg, 69126

GER013, München, Bayern, Germany

Status

Address

GER013

München, Bayern, 80335

GER010, Gießen, Hessen, Germany

Status

Address

GER010

Gießen, Hessen, 35392

GER005, Immenhausen, Hessen, Germany

Status

Address

GER005

Immenhausen, Hessen, 34376

GER003, Essen, Nordrhein-Westfalen, Germany

Status

Address

GER003

Essen, Nordrhein-Westfalen, 45239

GER009, Homburg, Saarland, Germany

Status

Address

GER009

Homburg, Saarland, 66424

GER008, Halle, Sachsen-Anhalt, Germany

Status

Address

GER008

Halle, Sachsen-Anhalt, 06120

GER001, Dresden, Sachsen, Germany

Status

Address

GER001

Dresden, Sachsen, 01307

GER002, Berlin, Germany

Status

Address

GER002

Berlin, , 13125

GER012, Berlin, Germany

Status

Address

GER012

Berlin, , 14050

GER004, Munich, Germany

Status

Address

GER004

Munich, , 81377

ITA003, Napoli, Campania, Italy

Status

Address

ITA003

Napoli, Campania, 80131

ITA005, Milano, Lombardia, Italy

Status

Address

ITA005

Milano, Lombardia, 20122

ITA004, Milano, Lombardia, Italy

Status

Address

ITA004

Milano, Lombardia, 20123

ITA002, Monza, Lombardia, Italy

Status

Address

ITA002

Monza, Lombardia, 20900

ITA006, Rozzano, Lombardia, Italy

Status

Address

ITA006

Rozzano, Lombardia, 20089

ITA001, Palermo, Sicilia, Italy

Status

Address

ITA001

Palermo, Sicilia, 90127

NZL001, Christchurch, Canterbury, New Zealand

Status

Address

NZL001

Christchurch, Canterbury, 8011

NZL002, Dunedin, Otago, New Zealand

Status

Address

NZL002

Dunedin, Otago, 9016

NZL003, Hamilton, Waikato, New Zealand

Status

Address

NZL003

Hamilton, Waikato, 3204

USA014, Guaynabo, Puerto Rico

Status

Address

USA014

Guaynabo, , 00926

ESP007, Oviedo, Asturias, Spain

Status

Address

ESP007

Oviedo, Asturias, 33011

ESP003, Palma de Mallorca, Baleares, Spain

Status

Address

ESP003

Palma de Mallorca, Baleares, 07120

ESP001, Santander, Cantabria, Spain

Status

Address

ESP001

Santander, Cantabria, 39008

ESP010, Barcelona, Spain

Status

Address

ESP010

Barcelona, , 08035

ESP005, Barcelona, Spain

Status

Address

ESP005

Barcelona, , 08907

ESP006, las Palmas de Gran Canaria, Spain

Status

Address

ESP006

las Palmas de Gran Canaria, , 35010

ESP002, Madrid, Spain

Status

Address

ESP002

Madrid, , 28046

ESP009, Santiago de Compostela, Spain

Status

Address

ESP009

Santiago de Compostela, , 15706

GBR003, Glasgow, Lanarkshire, United Kingdom

Status

Address

GBR003

Glasgow, Lanarkshire, G81 4HX

GBR002, Salford, Lancashire, United Kingdom

Status

Address

GBR002

Salford, Lancashire, M6 8HD

GBR005, London, London, City Of, United Kingdom

Status

Address

GBR005

London, London, City Of, SW3 6HP

GBR004, London, London, City Of, United Kingdom

Status

Address

GBR004

London, London, City Of, W12 0HS

GBR001, Sheffield, Yorkshire, United Kingdom

Status

Address

GBR001

Sheffield, Yorkshire, S10 2JF