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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
344
Oral inhalation using a capsule-based dry powder inhaler device.
Oral inhalation using a capsule-based dry powder inhaler device.
Change in 6MWD Measured at Peak Exposure From Baseline to Week 24
Time frame: Baseline, Week 24
Time From Randomization to First Clinical Worsening Over the 24-Week Treatment Period
Time frame: Up to Week 24
Time From Randomization to First Major Morbidity or Mortality Event Over the 24-Week Treatment Period
Time frame: Up to Week 24
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
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
Change in 6MWD Measured at Trough Exposure From Baseline to Week 22
Time frame: Baseline, Week 22
Change From Baseline in 6MWD Measured at Peak Exposure Over 20 Weeks
Time frame: Baseline up to Week 20
Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Total Symptom Domain Score Over 24 Weeks
Time frame: Baseline up to Week 24
Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Time frame: Pre-dose and post-dose at multiple timepoints up to Week 24
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