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Completed

NCT Number: NCT05649722

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

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

ARG003, Autonomus City of Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 INS1009-211, or any other lead-in PH-ILD TPIP study.
  • Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion criteria

  • Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an 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 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.

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 abnormalities at screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease that may present an unreasonable risk to the study participant as a result of participation in the study.

Treatment and study plan

Treprostinil Palmitil Inhalation Powder

Drug

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

Other names: INS1009

Placebo

Drug

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

Primary outcomes

  1. Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)

    Time frame: Up to approximately 25 months

Secondary outcomes

  1. Absolute Change From Pre-Open-Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD)

    Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24

  2. Relative Change From Pre-OLE Baseline in 6-MWD

    Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24

  3. Change From Pre-OLE Baseline in Forced Vital Capacity (FVC)

    Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24

  4. Change From Pre-OLE Baseline in Percent Predicted FVC (FVC%)

    Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24

  5. Change From Pre-OLE Baseline in Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24

  6. Change From Pre-OLE Baseline in Percent Predicted FEV1 (FEV1%)

    Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24

  7. Change From Pre-OLE Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75%)

    Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24

  8. Absolute Change From Pre-OLE Baseline in Lung Diffusion Capacity for Carbon Monoxide (DLCO)

    Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24

  9. Relative Change From Pre-OLE Baseline in Lung DLCO

    Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24

  10. Change From Pre-OLE Baseline in the Concentration of N-Terminal Fragment B-Type Natriuretic Peptide (NT-proBNP) in Blood

    Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 6, 12, 18, and 24

  11. Annualized Rate of Clinical Worsening Events Based on Percentage of Participants With Clinical Worsening Events

    Time frame: Up to Month 24

    Clinical worsening events are defined as one of the following: Hospitalization due to a cardiopulmonary indication; Lung transplantation; Death from any cause; Decrease in 6MWD ≥ 15% from baseline; Directly related to disease under study, at 2 consecutive visits at least 24 hours apart; Need for additional pulmonary hypertension (PH) therapy. Annualized clinical worsening event rate is defined as the total number of clinical worsening events that occurred during the treatment period divided by the total number of participant-years during the treatment period.

  12. Annualized Rate of Occurrence of Acute Exacerbations of Underlying Interstitial Lung Disease (AE-ILDs)

    Time frame: Up to Month 24

  13. Change From OLE Baseline in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Score

    Time frame: OLE Baseline (Day 1) to Months 6, 12, 18, and 24

  14. Change From OLE Baseline in the Euro Quality of Life-5 Dimension-5 Level (EQ-5D-5L) Questionnaire Score

    Time frame: OLE Baseline (Day 1) to Months 6, 12, 18, and 24

  15. Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE)

    Time frame: OLE Baseline (Day 1), Months 6, 12, 18, and 24

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study title

An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term Use of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 14, 2022
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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