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NCT07179380PHASE3Recruiting

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

Insmed Incorporated

Start Date

1/7/2026

Completion Date

12/30/2028

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * Diagnosis of PH World Health Organisation (WHO) Group 3 associated with ILD \[including but not limited to idiopathic interstitial pneumonia (IIP), chronic hypersensitivity pneumonitis (HSP), connective tissue disease-associated interstitial lung disease (CTD-ILD), combined pulmonary fibrosis and emphysema (CPFE)\]. * Confirmation of fibrotic interstitial lung disease by centrally overread computed tomography (CT) scan performed at Screening or within prior 12 months. * PH confirmed by right heart catheterization (RHC) at Screening or within 12 months prior to Screening, with the following hemodynamic findings: * Mean pulmonary arterial pressure (mPAP) \>20 millimetre of mercury (mmHg) and * Pulmonary capillary wedge pressure (PCWP) of ≤15 mmHg and * Pulmonary vascular resistance (PVR) ≥4 wood units (WU). * 6 Minute walking distance (6MWD) ≥100 and ≤500 meters at two 6MWTs at Screening performed at least 4 hours apart, with the difference between the 2 distances ≤15%. * Participants receiving chronic medication for underlying disease (e.g., antifibrotic, immunomodulators, immunosuppressants, etc.) and/or phosphodiesterase 5 (PDE5) inhibitors, should be on this treatment for ≥90 days and on a stable dose for ≥30 days prior to Screening. * Capable of giving signed informed consent as described in Section 10.1.5 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion criteria * Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease. * Primary diagnosis of chronic obstructive pulmonary disease (COPD) and/or forced expiratory volume in 1 second (FEV1)/FVC \<0.7 (based on screening or historical spirometry within the prior 6 months). * Clinically significant left heart disease: * evidence of clinically significant left-sided valvular heart disease, * left ventricular failure with left ventricular ejection fraction (LVEF) \<45%, or diagnosis of heart failure with preserved ejection fraction (HFpEF) * echocardiography findings at Screening suggestive for postcapillary PH * unstable ischemic heart disease * unstable arrhythmia, including uncontrolled atrial fibrillation (rate-controlled arrhythmia or paroxysmal atrial fibrillation is allowed) * Evidence of chronic thromboembolic disease or recent (within 6 months of Screening) acute pulmonary embolism. * Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (e.g., mannitol, leucine). * Current use of cigarettes or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime and who currently smokes either every day or some days. * Current use of inhaled marijuana, recreational or medical (current use defined as used at least one or more times during the past 30 days prior to Screening) or expected use during the study. * Any other medical or psychological condition including relevant laboratory abnormalities at Screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease and/or may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may impede their ability complete the study or the study assessments or confound the outcomes of the trial. Note: Other protocol defined inclusion/exclusion criteria may apply.

Interventions

DRUG

Treprostinil Palmitil Inhalation Powder

DRUG

Placebo

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Conditions

Pulmonary HypertensionInterstitial Lung Disease

Locations

USA010

Los Angeles, California 900275969

United States

USA001

Santa Barbara, California 93105-4349

United States

USA006

Naples, Florida 34102-5412

United States

USA026

St. Petersburg, Florida 33707-6129

United States

USA002

Kansas City, Kansas 66160

United States

USA003

Bend, Oregon 97701

United States

USA013

Philadelphia, Pennsylvania 19140

United States

USA008

Richmond, Virginia 23230

United States

ARG002

CiudadAutonoma de Buenos Aires, Buenos Aires C1280AEB

Argentina

ARG003

Río Cuarto, Córdoba Province X5800AEV

Argentina

ARG008

San Miguel de Tucumán, Tucumán Province T4000AXL

Argentina

ARG004

Córdoba, X5000KEH

Argentina

ARG001

Córdoba, X5003DCE

Argentina

AUS001

Camperdown, New South Wales 2050

Australia

AUS006

Kingswood, New South Wales 2747

Australia

AUS005

New Lambton Heights, New South Wales 2305

Australia

AUS003

Westmead, New South Wales 2145

Australia

AUT002

Innsbruck, 6020

Austria

BEL002

Leuven, Vlaams Brabant 3000

Belgium

BEL001

Anderlecht, 1070

Belgium

CZE001

Prague, 14000

Czechia

DNK001

Aarhus N, Central Jutland 8200

Denmark

FRA009

Nice, Alpes-Maritimes 6001

France

FRA002

Marseille, Bouches-du-Rhône 13015

France

FRA004

Angers, Maine-et-Loire 49100

France

FRA007

Lille, Nord 59037

France

FRA008

Saint Priest En Jarez, Pays de la Loire Region 42270

France

FRA003

Le Kremlin-Bicêtre, Val-de-Marne 94270

France

FRA001

Poitiers, Vienne 86000

France

FRA010

Brest, 29200

France

FRA011

Bron, 69500

France

FRA006

Strasbourg, 67091

France

GEO002

Tbilisi, 0144

Georgia

GEO004

Tbilisi, 0159

Georgia

GEO003

Tbilisi, 0180

Georgia

GEO001

Tbilisi, 0186

Georgia

DEU005

Immenhausen, Baden-Wurttemberg 34376

Germany

DEU012

Stuttgart, Baden-Wurttemberg 70376

Germany

DEU003

München, Bavaria 80335

Germany

DEU006

München, Bavaria 80639

Germany

DEU008

Bonn, North Rhine-Westphalia 53127

Germany

DEU009

Homburg, Saarland 66424

Germany

DEU011

Lübeck, Schleswig-Holstein 23562

Germany

DEU010

Gauting, 82131

Germany

GRC003

Pátrai, Achaia 26504

Greece

GRC002

Athens, Anatoliki Attiki 106 76

Greece

ISR003

Petah Tikva, Central District 4941492

Israel

ISR002

Jerusalem, Jerusalem 9112001

Israel

ISR005

Haifa, 3109601

Israel

ISR001

Haifa, 3436212

Israel

ISR004

Tel Aviv, 6423906

Israel

ITA011

Bologna, Emilia-Romagna 40138

Italy

ITA008

Milan, 20123

Italy

ITA001

Pavia, 27100

Italy

ITA003

Roma, 161

Italy

ITA012

Sassari, 07100

Italy

JPN006

Nagakute, Aichi-ken 480-1195

Japan

JPN011

Hirosaki, Aomori 036-8563

Japan

JPN002

Narashino-shi, Chiba 275-0006

Japan

JPN004

Narita-shi, Chiba 286-8520

Japan

JPN001

Sapporo, Hokkaido 060-8648

Japan

JPN007

Yokohama, Kanagawa 236-0051

Japan

JPN010

Kyotoshi, Kyoto 606-8507

Japan

JPN005

Nagano, Nagano 380-0928

Japan

JPN015

Sakai, Osaka 590-0197

Japan

JPN013

Bunkyo-Ku, Tokyo 113-8431

Japan

JPN008

Kiyose, Tokyo 204-0023

Japan

JPN003

Shibuya City, Tokyo 151-8528

Japan

JPN014

Chiba, 260-8677

Japan

JPN016

Tsukuba, 305-8576

Japan

MYS004

Alor Star, Kedah 5460

Malaysia

MYS001

Kota Bharu, Kelantan 15586

Malaysia

MYS003

Kuantan, Pahang 25200

Malaysia

MYS002

Kuching, Sarawak 93586

Malaysia

MYS005

Kajang, Selangor 43000

Malaysia

NZL001

Christchurch, Canterbury 8011

New Zealand

NZL002

Dunedin, Otago 9010

New Zealand

PRT002

Almada, Setúbal District 2805-267

Portugal

PRT001

Lisbon, 1769-001

Portugal

ROU002

Târgu Mureş, Mureș County 540136

Romania

ROU001

Timișoara, Timiș County 300310

Romania

KOR002

Incheon, 21565

South Korea

KOR001

Seoul, 03080

South Korea

KOR004

Seoul, 3722

South Korea

KOR006

Seoul, 6351

South Korea

KOR003

Seoul, 6591

South Korea

KOR005

Wŏnju, 26426

South Korea

ESP002

Palma de Mallorca, Balearic Islands 7120

Spain

ESP005

L'Hospitalet de Llobregat, Barcelona 8907

Spain

ESP010

Majadahonda, Madrid 28222

Spain

ESP012

Barcelona, 8035

Spain

ESP004

Barcelona, 8036

Spain

ESP006

Madrid, 28041

Spain

ESP003

Madrid, 28046

Spain

ESP009

Madrid, 28304

Spain

ESP011

Santiago de Compostela, 15706

Spain

ESP001

Seville, 41009

Spain

ESP007

Toledo, 45007

Spain

CHE001

Basel, 4031

Switzerland

CHE002

Zurich, 8091

Switzerland

TWN003

Hsinchu, 300

Taiwan

TWN001

Kaohsiung City, 80756

Taiwan

TWN005

Taichung, 40447

Taiwan

TWN002

Taipei, 10002

Taiwan

TWN006

Taipei, 104

Taiwan

GBR009

London, Greater London W12 0HS

United Kingdom

GBR004

Sheffield, Yorkshire S10 2JF

United Kingdom

GBR002

London, NW3 2QG

United Kingdom

GBR005

Southampton, SO16 6YD

United Kingdom