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RECRUITING
NCT07179380
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

Treprostinil Palmitil Inhalation Powder

Oral inhalation using a capsule-based dry powder inhaler device.

DRUG

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