An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Last updated: March 28, 2025
Sponsor: Insmed Incorporated
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Stress

Scleroderma

Pulmonary Arterial Hypertension

Treatment

Treprostinil Palmitil Inhalation Powder

Placebo

Clinical Study ID

NCT05649722
INS1009-212
2023-505540-19-00
2022-001950-45
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who completed the end of treatment visit in Study INS1009-211 (NCT05176951). Participants for whom the OLE study was not available at the time oftheir completion of the lead-in study are eligible for enrolment within one year oftheir lead-in end of treatment visit.

  • Complete baseline screening assessments to confirm eligibility to participate ifmore than 30 days have elapsed since the end of the study visit in StudyINS1009-211, or any other lead-in PH-ILD TPIP study.

  • Capable of giving signed informed consent that includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in thisprotocol.

Exclusion

Exclusion Criteria:

  • Participants who experienced any hypersensitivity or adverse drug reaction or werewithdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinionof the Investigator, could indicate that continued treatment with TPIP may presentan unreasonable risk for the participant.

  • Initiation of parenteral administration of prostacyclin analogues (eg, TRE,epoprostenol) since the completion of Study INS1009-211 or other TPIP studies.Initiation of inhaled prostacyclin analogues (eg, TRE [Tyvaso] or iloprost) and oralprostacyclin analogues (eg, TRE [Orenitram]) or receptor agonists (eg, selexipag)are permitted if stopped 24 hours prior to the start of study drug administration.

Pregnant or breastfeeding. Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug.

  • Any medical or psychological condition, including relevant laboratory abnormalitiesat screening that, in the opinion of the Investigator, suggest a new and/orinsufficiently understood disease that may present an unreasonable risk to the studyparticipant as a result of participation in the study.

Study Design

Total Participants: 31
Treatment Group(s): 2
Primary Treatment: Treprostinil Palmitil Inhalation Powder
Phase: 2/3
Study Start date:
May 11, 2023
Estimated Completion Date:
March 14, 2026

Connect with a study center

  • ARG003

    Autonomus City Of Buenos Aires, Buenos Aires C1280AEB
    Argentina

    Site Not Available

  • ARG001

    Rosario, Santa Fe S2013KDS
    Argentina

    Site Not Available

  • AUS005

    Macquarie Park, New South Wales 2109
    Australia

    Site Not Available

  • BEL002

    Liège, 4000
    Belgium

    Site Not Available

  • GER006

    Heidelberg, Baden-Württemberg 69126
    Germany

    Site Not Available

  • GER004

    München, Bayern 81377
    Germany

    Site Not Available

  • GER010

    Gießen, Hessen 35392
    Germany

    Site Not Available

  • GER003

    Essen, Nordrhein-Westfalen 45239
    Germany

    Site Not Available

  • GER001

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • GER002

    Berlin, 13125
    Germany

    Site Not Available

  • GER012

    Berlin, 14050
    Germany

    Site Not Available

  • ITA004

    Milan, Lombardia 20123
    Italy

    Site Not Available

  • ITA002

    Monza, Lombardia 20900
    Italy

    Site Not Available

  • ITA001

    Palermo, Sicilia 90127
    Italy

    Site Not Available

  • ITA003

    Napoli, 80131
    Italy

    Site Not Available

  • ESP007

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • ESP009

    Santiago de Compostela, Galicia 15706
    Spain

    Site Not Available

  • ESP003

    Palma, Islas Baleares 07120
    Spain

    Site Not Available

  • ESP005

    Barcelona, 08907
    Spain

    Site Not Available

  • ESP010

    Barcelona, 8035
    Spain

    Site Not Available

  • GBR003

    Clydebank, Glasgow G81 4DY
    United Kingdom

    Site Not Available

  • GBR001

    Sheffield, South Yorkshire S10 2JF
    United Kingdom

    Site Not Available

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