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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Oral inhalation using a capsule-based dry powder inhaler device.
Oral placebo inhalation using a capsule-based dry powder inhaler device.
ARG003
Autonomus City of Buenos Aires, Buenos Aires, Argentina
ARG001
Rosario, Santa Fe Province, Argentina
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 25 months
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
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
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
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
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
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
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
Absolute Change From Pre-OLE Baseline in Lung Diffusion Capacity for Carbon Monoxide (DLCO)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUS005
Macquarie Park, New South Wales, Australia
BEL002
Liège, Belgium
GER006
Heidelberg, Baden-Wurttemberg, Germany
GER004
München, Bavaria, Germany
GER010
Giessen, Hesse, Germany
GER003
Essen, North Rhine-Westphalia, Germany
GER001
Dresden, Saxony, Germany
GER002
Berlin, Germany
...and 12 more locations
Time frame: Pre-OLE Baseline (Baseline of the lead-in TPIP study) to Months 12 and 24
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
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
Annualized Rate of Clinical Worsening Events Based on Percentage of Participants With Clinical Worsening Events
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.
Time frame: Up to Month 24
Annualized Rate of Occurrence of Acute Exacerbations of Underlying Interstitial Lung Disease (AE-ILDs)
Time frame: Up to Month 24
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
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
Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Time frame: OLE Baseline (Day 1), Months 6, 12, 18, and 24