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

Last updated: March 13, 2025
Sponsor: Insmed Incorporated
Overall Status: Completed

Phase

2

Condition

Scleroderma

Williams Syndrome

Pulmonary Arterial Hypertension

Treatment

Treprostinil Palmitil

Placebo

Clinical Study ID

NCT05176951
INS1009-211
2021-003294-66
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females must be ≥ 18 to ≤ 80 years of age at the time of signing theinformed consent form (ICF).

  • Diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD) (including idiopathic interstitial pneumonia [IIP], idiopathic pulmonaryfibrosis [IPF], connective tissue disease [CTD], sarcoidosis).

  • Male and female participants must use contraceptives that are consistent with localregulations regarding the methods of contraception for those participating inclinical 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 12months without an alternative medical cause), surgically sterile, (ie,hysterectomyand/or bilateral salpingo-oophorectomy) or using highly effective contraceptionmethods (ie, methods that alone or in combination achieve <1% unintended pregnancyrates per year when used consistently and correctly) from Day 1 to at least 90 daysafter the last dose of study drug.

  • Capable of giving signed informed consent that includes compliance with therequirements and restrictions listed in the ICF and in this protocol.

Exclusion

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 analogueswithin 30 days prior to Screening.

  • Started therapy with pirfenidone or nintedanib < 90 days prior to Screening, OR, ifalready receiving either medication, there is a dose change within 30 days ofScreening Visit.

  • Any known ventricular or supraventricular tachyarrhythmia (except for paroxysmalatrial fibrillation), and/or any symptomatic bradycardia.

  • History of heart disease including left ventricular ejection fraction (LVEF) ≤ 40%or clinically significant valvular, constrictive, or symptomatic atheroscleroticheart disease (eg, stable angina, myocardial infarction, etc).

  • Participation in a cardiopulmonary rehabilitation program within 30 days of thefirst Screening Visit. Participation in the maintenance program of a cardiopulmonaryrehabilitation program is allowed.

  • Acutely decompensated heart failure within 30 days of Screening Visit.

  • Active and current symptomatic coronavirus disease 2019 (COVID-19) and/or previousdiagnosis 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 respiratoryinfection within 30 days of the first dose of study drug (may be rescreened atappropriate time).

  • Current or recent (past 30 days) lower respiratory tract infection (may berescreened at appropriate time).

  • Any form of congenital heart disease or congenital heart defect (repaired orunrepaired) 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)) ore-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetimeand 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 complywith study requirements, in particular with 6-minute walk test (6MWT) (eg, anginapectoris, claudication, musculoskeletal disorder, need for walking aids).

Study Design

Total Participants: 39
Treatment Group(s): 2
Primary Treatment: Treprostinil Palmitil
Phase: 2
Study Start date:
December 22, 2022
Estimated Completion Date:
March 14, 2024

Connect with a study center

  • ARG006

    Villa Vatteone, Buenos Aires B1853AIK
    Argentina

    Site Not Available

  • ARG003

    Barracas, Ciudad Autónoma De BuenosAires C1280AEB
    Argentina

    Site Not Available

  • ARG007

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

    Site Not Available

  • ARG004

    Villa Regina, Río Negro R8336
    Argentina

    Site Not Available

  • ARG001

    Rosario, Santa Fe S2013KDS
    Argentina

    Site Not Available

  • ARG002

    San Miguel De Tucumán, Tucumán T4000AXL
    Argentina

    Site Not Available

  • ARG002

    San Miguel de Tucuman, Tucumán T4000AXL
    Argentina

    Site Not Available

  • ARG008

    Buenos Aires, CI094AAD
    Argentina

    Site Not Available

  • AUS003

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • AUS005

    Macquarie Park, New South Wales 2109
    Australia

    Site Not Available

  • AUS001

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • AUS002

    Milton, Queensland 4064
    Australia

    Site Not Available

  • AUS004

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • BEL001

    Anderlecht, Brussels 1070
    Belgium

    Site Not Available

  • BEL003

    Leuven, Vlaams Brabant 3000
    Belgium

    Site Not Available

  • BEL002

    Liège, 4000
    Belgium

    Site Not Available

  • GER006

    Heidelberg, Baden-Württemberg 69126
    Germany

    Site Not Available

  • GER013

    München, Bayern 80335
    Germany

    Site Not Available

  • GER010

    Gießen, Hessen 35392
    Germany

    Site Not Available

  • GER005

    Immenhausen, Hessen 34376
    Germany

    Site Not Available

  • GER003

    Essen, Nordrhein-Westfalen 45239
    Germany

    Site Not Available

  • GER009

    Homburg, Saarland 66424
    Germany

    Site Not Available

  • GER001

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • GER008

    Halle, Sachsen-Anhalt 06120
    Germany

    Site Not Available

  • GER002

    Berlin, 13125
    Germany

    Site Not Available

  • GER012

    Berlin, 14050
    Germany

    Site Not Available

  • GER004

    Munich, 81377
    Germany

    Site Not Available

  • ITA003

    Napoli, Campania 80131
    Italy

    Site Not Available

  • ITA007

    Modena, Emilia-Romagna 41124
    Italy

    Site Not Available

  • ITA004

    Milano, Lombardia 20123
    Italy

    Site Not Available

  • ITA005

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • ITA002

    Monza, Lombardia 20900
    Italy

    Site Not Available

  • ITA006

    Rozzano, Lombardia 20089
    Italy

    Site Not Available

  • ITA001

    Palermo, Sicilia 90127
    Italy

    Site Not Available

  • NZL001

    Christchurch, Canterbury 8011
    New Zealand

    Site Not Available

  • NZL002

    Dunedin, Otago 9016
    New Zealand

    Site Not Available

  • NZL003

    Hamilton, Waikato 3204
    New Zealand

    Site Not Available

  • USA014

    Guaynabo, 00926
    Puerto Rico

    Site Not Available

  • ESP007

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • ESP003

    Palma de Mallorca, Baleares 07120
    Spain

    Site Not Available

  • ESP001

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • ESP005

    Barcelona, 08907
    Spain

    Site Not Available

  • ESP010

    Barcelona, 08035
    Spain

    Site Not Available

  • ESP002

    Madrid, 28046
    Spain

    Site Not Available

  • ESP008

    Salamanca, 37007
    Spain

    Site Not Available

  • ESP009

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • ESP006

    las Palmas de Gran Canaria, 35010
    Spain

    Site Not Available

  • GBR007

    Bath, Avon BA1 3NG
    United Kingdom

    Site Not Available

  • GBR008

    Cambridge, Cambridgeshire CB2 0AY
    United Kingdom

    Site Not Available

  • GBR003

    Glasgow, Lanarkshire G81 4HX
    United Kingdom

    Site Not Available

  • GBR002

    Salford, Lancashire M6 8HD
    United Kingdom

    Site Not Available

  • GBR004

    London, London, City Of W12 0HS
    United Kingdom

    Site Not Available

  • GBR005

    London, London, City Of SW3 6HP
    United Kingdom

    Site Not Available

  • GBR006

    Edinburgh, Midlothian EH16 4SA
    United Kingdom

    Site Not Available

  • GBR001

    Sheffield, Yorkshire S10 2JF
    United Kingdom

    Site Not Available

  • USA007

    Los Angeles, California 90033-5313
    United States

    Site Not Available

  • USA008

    Aurora, Colorado 80045-2541
    United States

    Site Not Available

  • USA010

    Altamonte Springs, Florida 32701-4817
    United States

    Site Not Available

  • USA017

    Tampa, Florida 33606
    United States

    Site Not Available

  • USA002

    Atlanta, Georgia 30309-1281
    United States

    Site Not Available

  • USA002

    Austell, Georgia 30106-1110
    United States

    Site Not Available

  • USA013

    Indianapolis, Indiana 46260-1992
    United States

    Site Not Available

  • USA003

    Kansas City, Kansas 66160-8500
    United States

    Site Not Available

  • USA015

    Boston, Massachusetts 02111-1552
    United States

    Site Not Available

  • USA006

    Springfield, Massachusetts 01101
    United States

    Site Not Available

  • USA016

    Mineola, New York 11714
    United States

    Site Not Available

  • USA001

    Houston, Texas 77070
    United States

    Site Not Available

  • USA004

    McKinney, Texas 75069-8085
    United States

    Site Not Available

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