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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
2026-05-27
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 (109)
USA010
Los Angeles, California, United States
USA001
Santa Barbara, California, United States
USA006
Naples, Florida, United States
USA026
St. Petersburg, Florida, United States
USA002
Kansas City, Kansas, United States
USA003
Bend, Oregon, United States
USA013
Philadelphia, Pennsylvania, United States
USA008
Richmond, Virginia, United States
ARG002
CiudadAutonoma de Buenos Aires, Buenos Aires, Argentina
ARG003
Río Cuarto, Córdoba Province, Argentina
ARG008
San Miguel de Tucumán, Tucumán Province, Argentina
ARG004
Córdoba, Argentina
ARG001
Córdoba, Argentina
AUS001
Camperdown, New South Wales, Australia
AUS006
Kingswood, New South Wales, Australia
AUS005
New Lambton Heights, New South Wales, Australia
AUS003
Westmead, New South Wales, Australia
AUT002
Innsbruck, Austria
BEL002
Leuven, Vlaams Brabant, Belgium
BEL001
Anderlecht, Belgium
CZE001
Prague, Czechia
DNK001
Aarhus N, Central Jutland, Denmark
FRA009
Nice, Alpes-Maritimes, France
FRA002
Marseille, Bouches-du-Rhône, France
FRA004
Angers, Maine-et-Loire, France
FRA007
Lille, Nord, France
FRA008
Saint Priest En Jarez, Pays de la Loire Region, France
FRA003
Le Kremlin-Bicêtre, Val-de-Marne, France
FRA001
Poitiers, Vienne, France
FRA010
Brest, France
FRA011
Bron, France
FRA006
Strasbourg, France
GEO002
Tbilisi, Georgia
GEO004
Tbilisi, Georgia
GEO003
Tbilisi, Georgia
GEO001
Tbilisi, Georgia
DEU005
Immenhausen, Baden-Wurttemberg, Germany
DEU012
Stuttgart, Baden-Wurttemberg, Germany
DEU003
München, Bavaria, Germany
DEU006
München, Bavaria, Germany
DEU008
Bonn, North Rhine-Westphalia, Germany
DEU009
Homburg, Saarland, Germany
DEU011
Lübeck, Schleswig-Holstein, Germany
DEU010
Gauting, Germany
GRC003
Pátrai, Achaia, Greece
GRC002
Athens, Anatoliki Attiki, Greece
ISR003
Petah Tikva, Central District, Israel
ISR002
Jerusalem, Jerusalem, Israel
ISR005
Haifa, Israel
ISR001
Haifa, Israel
ISR004
Tel Aviv, Israel
ITA011
Bologna, Emilia-Romagna, Italy
ITA008
Milan, Italy
ITA001
Pavia, Italy
ITA003
Roma, Italy
ITA012
Sassari, Italy
JPN006
Nagakute, Aichi-ken, Japan
JPN011
Hirosaki, Aomori, Japan
JPN002
Narashino-shi, Chiba, Japan
JPN004
Narita-shi, Chiba, Japan
JPN001
Sapporo, Hokkaido, Japan
JPN007
Yokohama, Kanagawa, Japan
JPN010
Kyotoshi, Kyoto, Japan
JPN005
Nagano, Nagano, Japan
JPN015
Sakai, Osaka, Japan
JPN013
Bunkyo-Ku, Tokyo, Japan
JPN008
Kiyose, Tokyo, Japan
JPN003
Shibuya City, Tokyo, Japan
JPN014
Chiba, Japan
JPN016
Tsukuba, Japan
MYS004
Alor Star, Kedah, Malaysia
MYS001
Kota Bharu, Kelantan, Malaysia
MYS003
Kuantan, Pahang, Malaysia
MYS002
Kuching, Sarawak, Malaysia
MYS005
Kajang, Selangor, Malaysia
NZL001
Christchurch, Canterbury, New Zealand
NZL002
Dunedin, Otago, New Zealand
PRT002
Almada, Setúbal District, Portugal
PRT001
Lisbon, Portugal
ROU002
Târgu Mureş, Mureș County, Romania
ROU001
Timișoara, Timiș County, Romania
KOR002
Incheon, South Korea
KOR001
Seoul, South Korea
KOR004
Seoul, South Korea
KOR006
Seoul, South Korea
KOR003
Seoul, South Korea
KOR005
Wŏnju, South Korea
ESP002
Palma de Mallorca, Balearic Islands, Spain
ESP005
L'Hospitalet de Llobregat, Barcelona, Spain
ESP010
Majadahonda, Madrid, Spain
ESP012
Barcelona, Spain
ESP004
Barcelona, Spain
ESP006
Madrid, Spain
ESP003
Madrid, Spain
ESP009
Madrid, Spain
ESP011
Santiago de Compostela, Spain
ESP001
Seville, Spain
ESP007
Toledo, Spain
CHE001
Basel, Switzerland
CHE002
Zurich, Switzerland
TWN003
Hsinchu, Taiwan
TWN001
Kaohsiung City, Taiwan
TWN005
Taichung, Taiwan
TWN002
Taipei, Taiwan
TWN006
Taipei, Taiwan
GBR009
London, Greater London, United Kingdom
GBR004
Sheffield, Yorkshire, United Kingdom
GBR002
London, United Kingdom
GBR005
Southampton, United Kingdom