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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)
Sponsor: Insmed Incorporated
Summary
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.
Official 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
344
Start Date
2026-01-07
Completion Date
2028-12-30
Last Updated
2026-03-30
Healthy Volunteers
No
Interventions
Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder inhaler device.
Placebo
Oral inhalation using a capsule-based dry powder inhaler device.
Locations (49)
USA001
Santa Barbara, California, United States
USA006
Naples, Florida, United States
USA003
Bend, Oregon, United States
USA008
Richmond, Virginia, United States
ARG003
Río Cuarto, Córdoba Province, Argentina
ARG008
San Miguel de Tucumán, Tucumán Province, Argentina
BEL002
Leuven, Belgium
CZE001
Prague, Czechia
FRA003
Le Kremlin-Bicêtre, France
GEO002
Tbilisi, Georgia
GEO004
Tbilisi, Georgia
GEO003
Tbilisi, Georgia
GEO001
Tbilisi, Georgia
DEU012
Stuttgart, Baden-Wurttemberg, Germany
DEU003
München, Bavaria, Germany
DEU006
München, Bavaria, Germany
DEU005
Immenhausen, Hesse, Germany
DEU008
Bonn, North Rhine-Westphalia, Germany
DEU010
Gauting, Germany
ISR003
Petah Tikva, Central District, Israel
ISR001
Haifa, Israel
ISR002
Jerusalem, Israel
ISR004
Tel Aviv, Israel
ITA012
Sassari, Italy
JPN006
Nagakute, Aichi-ken, Japan
JPN002
Narashino-shi, Chiba, Japan
JPN004
Narita, Chiba, Japan
JPN001
Sapporo, Hokkaido, Japan
JPN007
Yokohama, Kanagawa, Japan
JPN013
Bunkyo-Ku, Tokyo, Japan
JPN008
Kiyose, Tokyo, Japan
JPN003
Shibuya City, Tokyo, Japan
JPN005
Nagano, Japan
NZL001
Christchurch, Canterbury, New Zealand
NZL002
Dunedin, Otago, New Zealand
PRT001
Lisbon, Portugal
KOR001
Seoul, South Korea
KOR006
Seoul, South Korea
KOR005
Wŏnju, South Korea
ESP010
Majadahonda, Madrid, Spain
ESP012
Barcelona, Spain
ESP004
Barcelona, Spain
ESP006
Madrid, Spain
ESP009
Madrid, Spain
ESP003
Madrid, Spain
ESP002
Palma de Mallorca, Spain
ESP011
Santiago de Compostela, Spain
ESP001
Seville, Spain
TWN001
Kaohsiung City, Taiwan