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Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

ConditionsPulmonary HypertensionInterstitial Lung Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsmed Incorporated

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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

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

Disqualifiers

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) <0.7 (based on screening or historical spirometry within the prior 6 months).

evidence of clinically significant left-sided valvular heart disease,

left ventricular failure with left ventricular ejection fraction (LVEF) <45%

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treprostinil Palmitil Inhalation Powder

    Drug

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

  • Placebo

    Drug

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

Treatment groups

344 Participants
are divided into 2 treatment groups
Group A: Treprostinil Palmitil Inhalation PowderExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in 6 Minute Walk Distance (6MWD) Measured at Peak Exposure From Baseline to Week 24

Time frame
Baseline, Week 24

Secondary outcomes

1

Time From Randomization to First Clinical Worsening Over the 24-Week Treatment Period

Time frame
Up to Week 24
2

Time From Randomization to First Major Morbidity or Mortality Event Over the 24-Week Treatment Period

Time frame
Up to Week 24
3

Change From Baseline in N-Terminal Pro Hormone Brain Natriuretic Peptide (NT-proBNP) Plasma Concentration Over 24 Weeks

Time frame
Baseline up to Week 24
4

Number of Participants With Greater Than or Equal to (>=) 30% Decrease in NT-proBNP or Who Maintained/Achieved Less Than (<) 300 Nanogram per Liter (ng/L) of NT-proBNP Level at Week 24

Time frame
At Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insmed Incorporated

Lead sponsor

Source ClinicalTrials.gov
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