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INS1009-311

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.

Details

Full study title A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel group Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease
Protocol number OCR49087
ClinicalTrials.gov ID NCT07179380
Phase Phase 3

Eligibility

Inclusion Criteria

  • Diagnosis of PH World Health Organisation (WHO) Group 3 associated with ILD [including but not limited to idiopathic interstitial pneumonia (IIP), chronic hypersensitivity pneumonitis (HSP), connective tissue disease-associated interstitial lung disease (CTD-ILD), combined pulmonary fibrosis and emphysema (CPFE).

  • Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at Screening or within prior 12 months.

  • PH confirmed by right heart catheterization (RHC) at Screening or within 12 months prior to Screening, with the following hemodynamic findings:

    • Mean pulmonary arterial pressure (mPAP) >20 millimetre of mercury (mmHg) and

    • Pulmonary capillary wedge pressure (PCWP) of ≤15 mmHg and

    • Pulmonary vascular resistance (PVR) ≥4 wood units (WU).

  • 6 Minute walking distance (6MWD) ≥100 and ≤500 meters at two 6 minute walking test (6MWT)s at Screening performed at least 4 hours apart, with the difference between the 2 distances ≤15%.

  • Participants receiving chronic medication for underlying disease (e.g., antifibrotic, immunomodulators, immunosuppressants, etc.) and/or phosphodiesterase 5 (PDE5) inhibitors, should be on this treatment for ≥90 days and on a stable dose for ≥30 days prior to Screening.

  • Capable of giving signed informed consent as described in Section 10.1.5 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion criteria

  • Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5 (including sarcoidosis), or subtypes of PH WHO Group 3 other than interstitial lung disease.

  • Primary diagnosis of chronic obstructive pulmonary disease (COPD) and/or forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC)

Lead researcher

  • Ali Ataya, MD
    Critical Care Medicine Specialist, Pulmonologist (Lung Specialist)

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
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  4. Step
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