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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
2026-10-26
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 (186)
USA027
Phoenix, Arizona, United States
USA007
Fresno, California, United States
USA010
Los Angeles, California, United States
USA023
Los Angeles, California, United States
USA020
San Francisco, California, United States
USA001
Santa Barbara, California, United States
USA017
Gainesville, Florida, United States
USA006
Naples, Florida, United States
USA026
St. Petersburg, Florida, United States
USA028
Tampa, Florida, United States
USA002
Kansas City, Kansas, United States
USA005
New York, New York, United States
USA022
Chapel Hill, North Carolina, United States
USA011
Durham, North Carolina, United States
USA015
Cincinnati, Ohio, United States
USA003
Bend, Oregon, United States
USA013
Philadelphia, Pennsylvania, United States
USA025
Salt Lake City, Utah, United States
USA008
Richmond, Virginia, United States
ARG010
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
ARG005
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
ARG002
CiudadAutonoma de Buenos Aires, Buenos Aires, Argentina
ARG003
Río Cuarto, Córdoba Province, Argentina
ARG011
Rosario, Santa Fe 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
AUS004
Auchenflower, Queensland, Australia
AUS002
South Brisbane, Queensland, Australia
AUT002
Innsbruck, Austria
AUT001
Linz, Austria
AUT003
Vienna, Austria
BEL002
Leuven, Vlaams Brabant, Belgium
BEL001
Anderlecht, Belgium
BRA001
Belo Horizonte, Minas Gerais, Brazil
BRA012
Porto Alegre, Rio Grande do Sul, Brazil
BRA007
Porto Alegre, Rio Grande do Sul, Brazil
BRA003
Porto Alegre, Rio Grande do Sul, Brazil
BRA010
Blumenau, Santa Catarina, Brazil
BRA005
Ribeirão Preto, São Paulo, Brazil
BRA002
São Paulo, Brazil
BRA006
São Paulo, Brazil
COL003
Bogotá D.C., Bogota D.C., Colombia
COL004
Bogotá, Cundinamarca, Colombia
COL002
Floridablanca, Santander Department, Colombia
COL001
Cali, Valle del Cauca Department, Colombia
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
FRA005
Pessac, France
FRA006
Strasbourg, France
GEO002
Tbilisi, Georgia
GEO004
Tbilisi, Georgia
GEO003
Tbilisi, Georgia
GEO001
Tbilisi, Georgia
DEU001
Heidelberg, Baden-Wurttemberg, Germany
DEU005
Immenhausen, Baden-Wurttemberg, Germany
DEU012
Stuttgart, Baden-Wurttemberg, Germany
DEU003
München, Bavaria, Germany
DEU006
München, Bavaria, Germany
DEU007
München, Bavaria, Germany
DEU008
Bonn, North Rhine-Westphalia, Germany
DEU002
Essen, North Rhine-Westphalia, Germany
DEU009
Homburg, Saarland, Germany
DEU004
Dresden, Saxony, Germany
DEU011
Lübeck, Schleswig-Holstein, Germany
DEU010
Gauting, Germany
GRC003
Pátrai, Achaia, Greece
GRC002
Athens, Anatoliki Attiki, Greece
GRC005
Kallithea, Attica, Greece
GRC004
Heraklion, Crete, Greece
GRC001
Thessaloniki, 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
ITA010
Catania, Italy
ITA008
Milan, Italy
ITA007
Modena, Italy
ITA005
Monza, Italy
ITA013
Naples, Italy
ITA001
Pavia, Italy
ITA003
Roma, Italy
ITA004
Rozzano, Italy
ITA012
Sassari, Italy
JPN006
Nagakute, Aichi-ken, Japan