RecruitingPhase 3NCT07179380

Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

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

Sponsor

Insmed Incorporated

Enrollment

344 participants

Start Date

Jan 7, 2026

Study Type

INTERVENTIONAL

Conditions

Interstitial Lung Disease Pulmonary Hypertension

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an inhaled treatment called TPIP (treprostinil palmitil inhalation powder) in people with pulmonary hypertension associated with interstitial lung disease (PH-ILD) — a serious condition where high blood pressure in the lung arteries develops alongside scarring or inflammation in the lung tissue. **You may be eligible if...** - You have been diagnosed with WHO Group 3 pulmonary hypertension connected to interstitial lung disease — which can include idiopathic interstitial pneumonia, hypersensitivity pneumonitis, connective tissue disease-related ILD, or combined pulmonary fibrosis and emphysema - Your ILD has been confirmed by a CT scan (within the last 12 months) - Your pulmonary hypertension has been confirmed by right heart catheterization (within the last 12 months) **You may NOT be eligible if...** - Your pulmonary hypertension is from a different cause (e.g., heart disease or blood clots) - You have ILD that does not show fibrotic features on CT - You do not meet the specific pressure measurements required from right heart catheterization Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTreprostinil Palmitil Inhalation Powder

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

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT07179380

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