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

NCT07179380 | Recruiting Phase 3 DMC FDA Drug

• 4 other identifiers: INS1009-3112025-521558-40-00jRCT20312505062025
• Study Type: interventional
• Target: 344
• Locations: 29 countries
• Sites: 182

Brief 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.

Conditions

Pulmonary Hypertension; Interstitial Lung Disease

Keywords

pulmonary hypertension; interstitial lung disease

Outcome Measures

Primary Outcomes (1)

• Change in 6 Minute Walk Distance (6MWD) Measured at Peak Exposure From Baseline to Week 24

  Baseline, Week 24

Secondary Outcomes (8)

• Time From Randomization to First Clinical Worsening Over the 24-Week Treatment Period

  Up to Week 24

• Time From Randomization to First Major Morbidity or Mortality Event Over the 24-Week Treatment Period

  Up to Week 24

• Change From Baseline in N-Terminal Pro Hormone Brain Natriuretic Peptide (NT-proBNP) Plasma Concentration Over 24 Weeks

  Baseline up to Week 24

• Number of Participants With Greater Than or Equal to (>=) 30% Decrease in NT-proBNP or Who Maintained/Achieved Less Than (<) 300 Nanogram per Liter (ng/L) of NT-proBNP Level at Week 24

  At Week 24

• Change in 6MWD Measured at Trough Exposure From Baseline to Week 22

  Baseline, Week 22

Study Arms (2)

Treprostinil Palmitil Inhalation Powder

EXPERIMENTAL

Participants will receive TPIP, once daily (QD), at a starting dose of 80 micrograms (μg) to maximum tolerated dose up to 1280 μg for 24 weeks.

Drug: Treprostinil Palmitil Inhalation Powder

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo matching TPIP QD for 24 weeks.

Drug: Placebo

Interventions

Treprostinil Palmitil Inhalation Powder DRUG

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

Also known as: INS1009

Treprostinil Palmitil Inhalation Powder

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Minute walking distance (6MWD) ≥100 and ≤500 meters at two 6 minute walking test (6MWT)s 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.

You may not qualify if:

• Diagnosis of Pulmonary Hypertension WHO Groups 1, 2, 4, or 5 (including sarcoidosis), 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)/ forced vital capacity (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%
• echocardiography findings at Screening suggestive for postcapillary (or combined pre and postcapillary) PH, heart failure with preserved ejection fraction (HFpEF), or heart failure with mildly reduced ejection fraction (HFmrEF), including left atrial volume index (LAVI) \>34 millilitres per metre square (mL/m\^2)
• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (185)

USA027

Phoenix, Arizona, 85013, United States

NOT YET RECRUITING

USA007

Fresno, California, 93720, United States

NOT YET RECRUITING

USA010

Los Angeles, California, 900275969, United States

NOT YET RECRUITING

USA023

Los Angeles, California, 90095, United States

NOT YET RECRUITING

USA020

San Francisco, California, 94143, United States

NOT YET RECRUITING

USA001

Santa Barbara, California, 93105-4349, United States

RECRUITING

USA017

Gainesville, Florida, 32610, United States

NOT YET RECRUITING

USA006

Naples, Florida, 34102-5412, United States

RECRUITING

USA026

St. Petersburg, Florida, 33707-6129, United States

RECRUITING

USA028

Tampa, Florida, 33606, United States

NOT YET RECRUITING

USA002

Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

USA005

New York, New York, 10016, United States

NOT YET RECRUITING

USA011

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

USA015

Cincinnati, Ohio, 45267, United States

NOT YET RECRUITING

USA003

Bend, Oregon, 97701, United States

RECRUITING

USA013

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

USA025

Salt Lake City, Utah, 84018, United States

NOT YET RECRUITING

USA008

Richmond, Virginia, 23230, United States

RECRUITING

ARG010

Ciudad Autónoma de Buenos Aires, Buenos Aires, 01093, Argentina

NOT YET RECRUITING

ARG005

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1060ABN, Argentina

RECRUITING

ARG002

CiudadAutonoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina

RECRUITING

ARG003

Río Cuarto, Córdoba Province, X5800AEV, Argentina

RECRUITING

ARG011

Rosario, Santa Fe Province, S2002KDS, Argentina

NOT YET RECRUITING

ARG008

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

RECRUITING

ARG004

Córdoba, X5000KEH, Argentina

RECRUITING

ARG001

Córdoba, X5003DCE, Argentina

NOT YET RECRUITING

AUS001

Camperdown, New South Wales, 2050, Australia

RECRUITING

AUS006

Kingswood, New South Wales, 2747, Australia

RECRUITING

AUS005

New Lambton Heights, New South Wales, 2305, Australia

RECRUITING

AUS003

Westmead, New South Wales, 2145, Australia

RECRUITING

AUS004

Auchenflower, Queensland, 4066, Australia

NOT YET RECRUITING

AUS002

South Brisbane, Queensland, 4101, Australia

NOT YET RECRUITING

AUT002

Innsbruck, 6020, Austria

NOT YET RECRUITING

AUT001

Linz, 4021, Austria

NOT YET RECRUITING

AUT003

Vienna, 1090, Austria

NOT YET RECRUITING

BEL002

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

BEL001

Anderlecht, 1070, Belgium

RECRUITING

BRA001

Belo Horizonte, Minas Gerais, 30441-070, Brazil

RECRUITING

BRA012

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

RECRUITING

BRA007

Porto Alegre, Rio Grande do Sul, 90560-030, Brazil

NOT YET RECRUITING

BRA003

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

BRA010

Blumenau, Santa Catarina, 89030-101, Brazil

NOT YET RECRUITING

BRA005

Ribeirão Preto, São Paulo, 14085-000, Brazil

NOT YET RECRUITING

BRA002

São Paulo, 04024-002, Brazil

RECRUITING

BRA006

São Paulo, 05403-000, Brazil

NOT YET RECRUITING

COL003

Bogotá D.C., Bogota D.C., 110131, Colombia

NOT YET RECRUITING

COL004

Bogotá, Cundinamarca, 111211, Colombia

NOT YET RECRUITING

COL002

Floridablanca, Santander Department, 681004, Colombia

NOT YET RECRUITING

COL001

Cali, Valle del Cauca Department, 760042, Colombia

RECRUITING

CZE001

Prague, 14000, Czechia

RECRUITING

DNK001

Aarhus N, Central Jutland, 8200, Denmark

RECRUITING

FRA009

Nice, Alpes-Maritimes, 6001, France

RECRUITING

FRA002

Marseille, Bouches-du-Rhône, 13015, France

RECRUITING

FRA004

Angers, Maine-et-Loire, 49100, France

RECRUITING

FRA007

Lille, Nord, 59037, France

RECRUITING

FRA008

Saint Priest En Jarez, Pays de la Loire Region, 42270, France

RECRUITING

FRA003

Le Kremlin-Bicêtre, Val-de-Marne, 94270, France

RECRUITING

FRA001

Poitiers, Vienne, 86000, France

RECRUITING

FRA010

Brest, 29200, France

RECRUITING

FRA011

Bron, 69500, France

RECRUITING

FRA005

Pessac, 33604, France

RECRUITING

FRA006

Strasbourg, 67091, France

RECRUITING

GEO002

Tbilisi, 0144, Georgia

RECRUITING

GEO004

Tbilisi, 0159, Georgia

RECRUITING

GEO003

Tbilisi, 0180, Georgia

RECRUITING

GEO001

Tbilisi, 0186, Georgia

RECRUITING

DEU001

Heidelberg, Baden-Wurttemberg, 69126, Germany

RECRUITING

DEU005

Immenhausen, Baden-Wurttemberg, 34376, Germany

RECRUITING

DEU012

Stuttgart, Baden-Wurttemberg, 70376, Germany

RECRUITING

DEU003

München, Bavaria, 80335, Germany

NOT YET RECRUITING

DEU006

München, Bavaria, 80639, Germany

RECRUITING

DEU007

München, Bavaria, 81377, Germany

NOT YET RECRUITING

DEU008

Bonn, North Rhine-Westphalia, 53127, Germany

NOT YET RECRUITING

DEU002

Essen, North Rhine-Westphalia, 45239, Germany

NOT YET RECRUITING

DEU009

Homburg, Saarland, 66424, Germany

NOT YET RECRUITING

DEU004

Dresden, Saxony, 1307, Germany

NOT YET RECRUITING

DEU011

Lübeck, Schleswig-Holstein, 23562, Germany

RECRUITING

DEU010

Gauting, 82131, Germany

RECRUITING

GRC003

Pátrai, Achaia, 26504, Greece

NOT YET RECRUITING

GRC002

Athens, Anatoliki Attiki, 106 76, Greece

RECRUITING

GRC005

Kallithea, Attica, 17674, Greece

NOT YET RECRUITING

GRC004

Heraklion, Crete, 71500, Greece

RECRUITING

GRC001

Thessaloniki, 54636, Greece

RECRUITING

ISR003

Petah Tikva, Central District, 4941492, Israel

RECRUITING

ISR002

Jerusalem, Jerusalem, 9112001, Israel

NOT YET RECRUITING

ISR005

Haifa, 3109601, Israel

RECRUITING

ISR001

Haifa, 3436212, Israel

RECRUITING

ISR004

Tel Aviv, 6423906, Israel

NOT YET RECRUITING

ITA011

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

ITA010

Catania, 95123, Italy

NOT YET RECRUITING

ITA008

Milan, 20123, Italy

NOT YET RECRUITING

ITA007

Modena, 41124, Italy

NOT YET RECRUITING

ITA005

Monza, 20900, Italy

RECRUITING

ITA013

Naples, 80131, Italy

NOT YET RECRUITING

ITA001

Pavia, 27100, Italy

RECRUITING

ITA003

Roma, 161, Italy

RECRUITING

ITA004

Rozzano, 20089, Italy

RECRUITING

ITA012

Sassari, 07100, Italy

NOT YET RECRUITING

JPN006

Nagakute, Aichi-ken, 480-1195, Japan

RECRUITING

JPN012

Seto, Aichi-ken, 489-8642, Japan

RECRUITING

JPN011

Hirosaki, Aomori, 036-8563, Japan

RECRUITING

JPN002

Narashino-shi, Chiba, 275-0006, Japan

RECRUITING

JPN004

Narita-shi, Chiba, 286-8520, Japan

RECRUITING

JPN001

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

JPN007

Yokohama, Kanagawa, 236-0051, Japan

RECRUITING

JPN010

Kyotoshi, Kyoto, 606-8507, Japan

RECRUITING

JPN009

Matsumoto, Nagano, 390-8621, Japan

NOT YET RECRUITING

JPN005

Nagano, Nagano, 380-0928, Japan

RECRUITING

JPN015

Sakai, Osaka, 590-0197, Japan

RECRUITING

JPN017

Suita, Osaka, 564-8565, Japan

RECRUITING

JPN013

Bunkyo-Ku, Tokyo, 113-8431, Japan

NOT YET RECRUITING

JPN008

Kiyose, Tokyo, 204-0023, Japan

NOT YET RECRUITING

JPN003

Shibuya City, Tokyo, 151-8528, Japan

RECRUITING

JPN014

Chiba, 260-8677, Japan

NOT YET RECRUITING

JPN016

Tsukuba, 305-8576, Japan

NOT YET RECRUITING

MYS004

Alor Star, Kedah, 5460, Malaysia

RECRUITING

MYS001

Kota Bharu, Kelantan, 15586, Malaysia

NOT YET RECRUITING

MYS003

Kuantan, Pahang, 25200, Malaysia

RECRUITING

MYS002

Kuching, Sarawak, 93586, Malaysia

NOT YET RECRUITING

MYS005

Kajang, Selangor, 43000, Malaysia

RECRUITING

MEX002

Monterrey, Nuevo León, 64460, Mexico

NOT YET RECRUITING

MEX001

Monterrey, Nuevo León, 64718, Mexico

NOT YET RECRUITING

MEX003

Mexico City, 14080, Mexico

NOT YET RECRUITING

NZL001

Christchurch, Canterbury, 8011, New Zealand

RECRUITING

NZL002

Dunedin, Otago, 9010, New Zealand

RECRUITING

PHL002

Iloilo City, 5000, Philippines

RECRUITING

PHL001

Makati City, 1229, Philippines

NOT YET RECRUITING

PHL003

Manila, 1015, Philippines

RECRUITING

PHL004

Quezon City, 1100, Philippines

NOT YET RECRUITING

POL002

Bialystok, 15276, Poland

NOT YET RECRUITING

POL006

Krakow, 31-202, Poland

NOT YET RECRUITING

POL004

Lublin, 20-718, Poland

NOT YET RECRUITING

POL001

Warsaw, 02-005, Poland

NOT YET RECRUITING

PRT002

Almada, Setúbal District, 2805-267, Portugal

RECRUITING

PRT001

Lisbon, 1769-001, Portugal

RECRUITING

ROU004

Cluj-Napoca, Cluj, 400371, Romania

RECRUITING

ROU002

Târgu Mureş, Mureș County, 540136, Romania

RECRUITING

ROU001

Timișoara, Timiș County, 300310, Romania

RECRUITING

ROU003

Bucharest, 11461, Romania

NOT YET RECRUITING

SRB001

Belgrade, 11000, Serbia

RECRUITING

SRB004

Belgrade, 11000, Serbia

NOT YET RECRUITING

SRB002

Kamenitz, 21102, Serbia

NOT YET RECRUITING

SRB003

Kragujevac, 34000, Serbia

RECRUITING

KOR002

Incheon, 21565, South Korea

RECRUITING

KOR001

Seoul, 03080, South Korea

RECRUITING

KOR004

Seoul, 3722, South Korea

RECRUITING

KOR006

Seoul, 6351, South Korea

RECRUITING

KOR003

Seoul, 6591, South Korea

RECRUITING

KOR005

Wŏnju, 26426, South Korea

RECRUITING

ESP002

Palma de Mallorca, Balearic Islands, 7120, Spain

RECRUITING

ESP005

L'Hospitalet de Llobregat, Barcelona, 8907, Spain

RECRUITING

ESP010

Majadahonda, Madrid, 28222, Spain

RECRUITING

ESP012

Barcelona, 8035, Spain

RECRUITING

ESP004

Barcelona, 8036, Spain

RECRUITING

ESP006

Madrid, 28041, Spain

RECRUITING

ESP003

Madrid, 28046, Spain

RECRUITING

ESP009

Madrid, 28304, Spain

RECRUITING

ESP011

Santiago de Compostela, 15706, Spain

RECRUITING

ESP001

Seville, 41009, Spain

RECRUITING

ESP007

Toledo, 45007, Spain

RECRUITING

CHE001

Basel, 4031, Switzerland

RECRUITING

CHE002

Zurich, 8091, Switzerland

RECRUITING

TWN004

Douliu City Yunlin County, 640, Taiwan

RECRUITING

TWN003

Hsinchu, 300, Taiwan

RECRUITING

TWN001

Kaohsiung City, 80756, Taiwan

RECRUITING

TWN005

Taichung, 40447, Taiwan

RECRUITING

TWN002

Taipei, 10002, Taiwan

NOT YET RECRUITING

TWN006

Taipei, 104, Taiwan

NOT YET RECRUITING

TUR003

Adana, 1250, Turkey (Türkiye)

RECRUITING

TUR004

Ankara, 6010, Turkey (Türkiye)

RECRUITING

TUR008

Ankara, 6560, Turkey (Türkiye)

NOT YET RECRUITING

TUR001

Bursa, 16059, Turkey (Türkiye)

NOT YET RECRUITING

TUR012

Eskişehir, 26040, Turkey (Türkiye)

RECRUITING

TUR005

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

TUR009

Kocaeli, 41380, Turkey (Türkiye)

RECRUITING

TUR011

Trabzon, 61080, Turkey (Türkiye)

NOT YET RECRUITING

GBR009

London, Greater London, W12 0HS, United Kingdom

NOT YET RECRUITING

GBR004

Sheffield, Yorkshire, S10 2JF, United Kingdom

RECRUITING

GBR001

Bath, BA1 3NG, United Kingdom

NOT YET RECRUITING

GBR008

Belfast, BT9 7AB, United Kingdom

NOT YET RECRUITING

GBR007

Glasgow, G81 4DY, United Kingdom

NOT YET RECRUITING

GBR002

London, NW3 2QG, United Kingdom

NOT YET RECRUITING

GBR003

London, SW3 6NP, United Kingdom

NOT YET RECRUITING

GBR010

Salford, M6 8HD, United Kingdom

NOT YET RECRUITING

GBR005

Southampton, SO16 6YD, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Study Director

  Insmed Incorporated

  STUDY DIRECTOR

Central Study Contacts

Insmed Medical Information

CONTACT

18444467633; medicalinformation@insmed.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); MY (5); GB (9); DE (12); KR (6); PT (2); NZ (2); US (18); TW (6); FR (11); IL (5); BE (2); ES (11); CZ (1); IT (10); AR (8); JP (17); BR (8); TU (8); SE (4); PH (4); ME (3); CH (2); PL (4); GE (4); CO (4); AU (6); RO (4); GR (5)